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New dietary guidelines omit recommended cuts to sugar, alcohol intake
Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.
The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.
The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions:
- Follow a healthy dietary pattern at every life stage.
- Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
- Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
- Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.
The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
Proposed cutoffs rejected
The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.
It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.
The agencies published a document explaining why they omitted the advisory committee›s conclusions.
The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.
In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.
“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
Guidance for infants and toddlers
The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise.
At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk.
The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.
Dr. Elkind highlighted the significance of these additions.
“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
For all ages
From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.
According to the guidelines, core elements of a healthy diet include:
- Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
- Fruits (especially whole fruit).
- Grains, at least half of which are whole grain.
- Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
- Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
- Oils, including vegetable oils and oils in food, such as seafood and nuts.
The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.
Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.
“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”
An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.
The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.
A version of this article first appeared on Medscape.com.
Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.
The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.
The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions:
- Follow a healthy dietary pattern at every life stage.
- Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
- Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
- Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.
The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
Proposed cutoffs rejected
The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.
It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.
The agencies published a document explaining why they omitted the advisory committee›s conclusions.
The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.
In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.
“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
Guidance for infants and toddlers
The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise.
At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk.
The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.
Dr. Elkind highlighted the significance of these additions.
“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
For all ages
From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.
According to the guidelines, core elements of a healthy diet include:
- Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
- Fruits (especially whole fruit).
- Grains, at least half of which are whole grain.
- Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
- Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
- Oils, including vegetable oils and oils in food, such as seafood and nuts.
The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.
Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.
“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”
An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.
The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.
A version of this article first appeared on Medscape.com.
Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.
The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.
The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions:
- Follow a healthy dietary pattern at every life stage.
- Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
- Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
- Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.
The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
Proposed cutoffs rejected
The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.
It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.
The agencies published a document explaining why they omitted the advisory committee›s conclusions.
The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.
In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.
“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
Guidance for infants and toddlers
The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise.
At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk.
The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.
Dr. Elkind highlighted the significance of these additions.
“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
For all ages
From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.
According to the guidelines, core elements of a healthy diet include:
- Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
- Fruits (especially whole fruit).
- Grains, at least half of which are whole grain.
- Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
- Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
- Oils, including vegetable oils and oils in food, such as seafood and nuts.
The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.
Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.
“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”
An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.
The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.
A version of this article first appeared on Medscape.com.
Teenage bone density declines following sleeve gastrectomy
Adolescents who undergo sleeve gastrectomy have lower bone density and higher bone marrow fat at 1 year following surgery, new research shows.
“It’s almost paradoxical,” Miriam Bredella, MD, of Massachusetts General Hospital in Boston, told Medscape Medical News. “Despite marked loss of body fat, these children have more fat in their bones and decreased bone density.”
She explained that the dissected part of the stomach is filled with anabolic cells that are important for building bone mass. “When those cells are cut out, the body cannot produce the hormones for building up bone.” It’s a malabsorption problem, she added. “Cutting out parts of the stomach or gut leads to less absorption.”
It is well known that bariatric surgery in adults has long-term effects on bone, she said, but this is the first time it has been studied in children.
“Nobody thinks about bone loss in children, but it’s extremely important,” Bredella reports. “The adolescent years up to age 25 are when we accrue bone density, so if something happens during this critical time, it can lead to weak bones later in life.” In the case of these adolescents, peak bone mass is never reached.
To investigate the effects of sleeve gastrectomy on bone density and marrow adipose tissue in extremely obese teenagers, researchers at Massachusetts General Hospital and Harvard Medical School recruited 52 adolescents with a mean body mass index (BMI) of 45. They measured volumetric bone mineral density using quantitative computer tomography (QCT) of the lumbar spine.
“We used QCT instead of DEXA [dual energy x-ray absorptiometry] scan because it isn’t affected by changes in soft tissue; it’s less susceptible to extreme changes in body weight,” Bredella said. “With DEXA scan there are too many artifacts.”
Half of the group (n = 26) underwent surgery. At 1 year, those who underwent surgery lost an average of 34 kg (75 lb). Adolescents in the control group lost an average of 0.2 kg (0.5 lb) (P < .0001).
Both groups repeated the QCT scan at the 1-year follow-up. Researchers found a decrease in bone density in those who underwent sleeve gastrectomy vs. controls (P = .046).
In her presentation, Bredella showed the QCT of the L2 spine in a 17-year old female before surgery and 12 months later. Her volumetric bone mineral density decreased from 183 mg/cm3 to 146 mg/cm3.
“Sleeve gastrectomy in children is bad for bones,” Bradella said. “You have to take care of your bones. This is something people are not thinking about and it probably won’t be a problem when they’re young but will likely affect these patients with osteoporosis when they are older.”
Patients need to be aware of this, she warns, and take steps to combat the bone loss. “Drinking milk, taking vitamin D, and doing weight-bearing exercise may help increase the bone density,” she said.
The increased fat in the bone is also concerning, she said. “Increased fat in the bone is a phenomenon that we see in anorexic patients,” Bredella explained.
The body appears to store the fat in bone in case of need later on, she explained. “We know that in severe states of malnutrition the body has the ability to metabolize the fat in the bones.”
The obesity epidemic in America has given way to a 100-fold increase in sleeve gastrectomy procedures in teenagers between 2005 and 2014. “These patients need this surgery so they don›t die of cardiac arrest or diabetes,” she said. “But we need to make sure they get their bone mineral density checked frequently.”
“The results of this study are important,” Marc Michalsky, MD, Nationwide Children’s Hospital, Columbus, Ohio, told Medscape Medical News. “But they need to be put into context.”
“There is an impetus and argument to support bariatric surgery as it offers a significant reduction in BMI and an associated reversal and complete amelioration of obesity related diseases.”
What this study doesn’t address, he said, is whether this population will experience an increase in bone density-related fractures down the road.
“These results are a snapshot in time — a picture of one postoperative time point,” Michalsky pointed out. “Are we seeing a process that represents continued change in bone mineralization? It’s not unreasonable to assume that the radiological findings here may lead to real clinical impact, but we don’t know.”
Bredella and Michalsky have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Adolescents who undergo sleeve gastrectomy have lower bone density and higher bone marrow fat at 1 year following surgery, new research shows.
“It’s almost paradoxical,” Miriam Bredella, MD, of Massachusetts General Hospital in Boston, told Medscape Medical News. “Despite marked loss of body fat, these children have more fat in their bones and decreased bone density.”
She explained that the dissected part of the stomach is filled with anabolic cells that are important for building bone mass. “When those cells are cut out, the body cannot produce the hormones for building up bone.” It’s a malabsorption problem, she added. “Cutting out parts of the stomach or gut leads to less absorption.”
It is well known that bariatric surgery in adults has long-term effects on bone, she said, but this is the first time it has been studied in children.
“Nobody thinks about bone loss in children, but it’s extremely important,” Bredella reports. “The adolescent years up to age 25 are when we accrue bone density, so if something happens during this critical time, it can lead to weak bones later in life.” In the case of these adolescents, peak bone mass is never reached.
To investigate the effects of sleeve gastrectomy on bone density and marrow adipose tissue in extremely obese teenagers, researchers at Massachusetts General Hospital and Harvard Medical School recruited 52 adolescents with a mean body mass index (BMI) of 45. They measured volumetric bone mineral density using quantitative computer tomography (QCT) of the lumbar spine.
“We used QCT instead of DEXA [dual energy x-ray absorptiometry] scan because it isn’t affected by changes in soft tissue; it’s less susceptible to extreme changes in body weight,” Bredella said. “With DEXA scan there are too many artifacts.”
Half of the group (n = 26) underwent surgery. At 1 year, those who underwent surgery lost an average of 34 kg (75 lb). Adolescents in the control group lost an average of 0.2 kg (0.5 lb) (P < .0001).
Both groups repeated the QCT scan at the 1-year follow-up. Researchers found a decrease in bone density in those who underwent sleeve gastrectomy vs. controls (P = .046).
In her presentation, Bredella showed the QCT of the L2 spine in a 17-year old female before surgery and 12 months later. Her volumetric bone mineral density decreased from 183 mg/cm3 to 146 mg/cm3.
“Sleeve gastrectomy in children is bad for bones,” Bradella said. “You have to take care of your bones. This is something people are not thinking about and it probably won’t be a problem when they’re young but will likely affect these patients with osteoporosis when they are older.”
Patients need to be aware of this, she warns, and take steps to combat the bone loss. “Drinking milk, taking vitamin D, and doing weight-bearing exercise may help increase the bone density,” she said.
The increased fat in the bone is also concerning, she said. “Increased fat in the bone is a phenomenon that we see in anorexic patients,” Bredella explained.
The body appears to store the fat in bone in case of need later on, she explained. “We know that in severe states of malnutrition the body has the ability to metabolize the fat in the bones.”
The obesity epidemic in America has given way to a 100-fold increase in sleeve gastrectomy procedures in teenagers between 2005 and 2014. “These patients need this surgery so they don›t die of cardiac arrest or diabetes,” she said. “But we need to make sure they get their bone mineral density checked frequently.”
“The results of this study are important,” Marc Michalsky, MD, Nationwide Children’s Hospital, Columbus, Ohio, told Medscape Medical News. “But they need to be put into context.”
“There is an impetus and argument to support bariatric surgery as it offers a significant reduction in BMI and an associated reversal and complete amelioration of obesity related diseases.”
What this study doesn’t address, he said, is whether this population will experience an increase in bone density-related fractures down the road.
“These results are a snapshot in time — a picture of one postoperative time point,” Michalsky pointed out. “Are we seeing a process that represents continued change in bone mineralization? It’s not unreasonable to assume that the radiological findings here may lead to real clinical impact, but we don’t know.”
Bredella and Michalsky have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Adolescents who undergo sleeve gastrectomy have lower bone density and higher bone marrow fat at 1 year following surgery, new research shows.
“It’s almost paradoxical,” Miriam Bredella, MD, of Massachusetts General Hospital in Boston, told Medscape Medical News. “Despite marked loss of body fat, these children have more fat in their bones and decreased bone density.”
She explained that the dissected part of the stomach is filled with anabolic cells that are important for building bone mass. “When those cells are cut out, the body cannot produce the hormones for building up bone.” It’s a malabsorption problem, she added. “Cutting out parts of the stomach or gut leads to less absorption.”
It is well known that bariatric surgery in adults has long-term effects on bone, she said, but this is the first time it has been studied in children.
“Nobody thinks about bone loss in children, but it’s extremely important,” Bredella reports. “The adolescent years up to age 25 are when we accrue bone density, so if something happens during this critical time, it can lead to weak bones later in life.” In the case of these adolescents, peak bone mass is never reached.
To investigate the effects of sleeve gastrectomy on bone density and marrow adipose tissue in extremely obese teenagers, researchers at Massachusetts General Hospital and Harvard Medical School recruited 52 adolescents with a mean body mass index (BMI) of 45. They measured volumetric bone mineral density using quantitative computer tomography (QCT) of the lumbar spine.
“We used QCT instead of DEXA [dual energy x-ray absorptiometry] scan because it isn’t affected by changes in soft tissue; it’s less susceptible to extreme changes in body weight,” Bredella said. “With DEXA scan there are too many artifacts.”
Half of the group (n = 26) underwent surgery. At 1 year, those who underwent surgery lost an average of 34 kg (75 lb). Adolescents in the control group lost an average of 0.2 kg (0.5 lb) (P < .0001).
Both groups repeated the QCT scan at the 1-year follow-up. Researchers found a decrease in bone density in those who underwent sleeve gastrectomy vs. controls (P = .046).
In her presentation, Bredella showed the QCT of the L2 spine in a 17-year old female before surgery and 12 months later. Her volumetric bone mineral density decreased from 183 mg/cm3 to 146 mg/cm3.
“Sleeve gastrectomy in children is bad for bones,” Bradella said. “You have to take care of your bones. This is something people are not thinking about and it probably won’t be a problem when they’re young but will likely affect these patients with osteoporosis when they are older.”
Patients need to be aware of this, she warns, and take steps to combat the bone loss. “Drinking milk, taking vitamin D, and doing weight-bearing exercise may help increase the bone density,” she said.
The increased fat in the bone is also concerning, she said. “Increased fat in the bone is a phenomenon that we see in anorexic patients,” Bredella explained.
The body appears to store the fat in bone in case of need later on, she explained. “We know that in severe states of malnutrition the body has the ability to metabolize the fat in the bones.”
The obesity epidemic in America has given way to a 100-fold increase in sleeve gastrectomy procedures in teenagers between 2005 and 2014. “These patients need this surgery so they don›t die of cardiac arrest or diabetes,” she said. “But we need to make sure they get their bone mineral density checked frequently.”
“The results of this study are important,” Marc Michalsky, MD, Nationwide Children’s Hospital, Columbus, Ohio, told Medscape Medical News. “But they need to be put into context.”
“There is an impetus and argument to support bariatric surgery as it offers a significant reduction in BMI and an associated reversal and complete amelioration of obesity related diseases.”
What this study doesn’t address, he said, is whether this population will experience an increase in bone density-related fractures down the road.
“These results are a snapshot in time — a picture of one postoperative time point,” Michalsky pointed out. “Are we seeing a process that represents continued change in bone mineralization? It’s not unreasonable to assume that the radiological findings here may lead to real clinical impact, but we don’t know.”
Bredella and Michalsky have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
FDA approves liraglutide for adolescents with obesity
The Food and Drug Administration’s new indication for liraglutide (Saxenda) for weight loss in adolescents with obesity, announced on Dec. 4, received welcome as a milestone for advancing a field that’s seen no new drug options since 2003 and boosted by 50% the list of agents indicated for weight loss in this age group.
But liraglutide’s track record in adolescents in the key study published earlier in 2020 left some experts unconvinced that liraglutide’s modest effects would have much impact on blunting the expanding cohort of teens who are obese.
“Until now, we’ve had phentermine and orlistat with FDA approval” for adolescents with obesity, and phentermine’s label specifies only patients older than 16 years. “It’s important that the FDA deemed liraglutide’s benefits greater than its risks for adolescents,” said Aaron S. Kelly, PhD, leader of the 82-week, multicenter, randomized study of liraglutide in 251 adolescents with obesity that directly led to the FDA’s action.
“We have results from a strong, published randomized trial, and the green light from the FDA, and that should give clinicians reassurance and confidence to use liraglutide clinically,” said Dr. Kelly, professor of pediatrics and codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota in Minneapolis.
An ‘unimpressive’ drop in BMI
Sonia Caprio, MD, had a more skeptical take on liraglutide’s role with its new indication: “Approval of higher-dose liraglutide is an improvement that reflects a willingness to accept adolescent obesity as a disease that needs treatment with pharmacological agents. However, the study, published in New England Journal of Medicine, was not impressive in terms of weight loss, and more importantly liraglutide was not associated with any significant changes in metabolic markers” such as insulin resistance, high-sensitivity C-reactive protein, lipoproteins and triglycerides, and hemoglobin A1c.
The observed average 5% drop in body mass index seen after a year on liraglutide treatment, compared with baseline and relative to no average change from baseline in the placebo arm, was “totally insufficient, and will not diminish any of the metabolic complications in youth with obesity,” commented Dr. Caprio, an endocrinologist and professor of pediatrics at Yale University in New Haven, Conn.
Results from the study led by Dr. Kelly also showed that liraglutide for 56 weeks cut BMI by 5% in 43% of patients, and by 10% in 26%, compared with respective rates of 19% and 8% among those in the placebo-control arm. He took a more expansive view of the potential benefits from weight loss of the caliber demonstrated by liraglutide in the study.
“In general, we wait too long with obesity in children; the earlier the intervention the better. A 3% or 4% reduction in BMI at 12 or 13 years old can pay big dividends down the road” when a typical adolescent trajectory of steadily rising weight can be flattened, he said in an interview.
Bariatric and metabolic surgery, although highly effective and usually safe, is seen by many clinicians, patients, and families as an “intervention of last resort,” and its very low level of uptake in adolescents bears witness to that reputation. It also creates an important niche for safe and effective drugs to fill as an adjunct to lifestyle changes, which are often ineffective when used by themselves. Liraglutide’s main mechanism for weight loss is depressing hunger, Dr. Kelly noted.
Existing meds have limitations
The existing medical treatments, orlistat and phentermine, both have significant drawbacks that limit their use. Orlistat (Xenical, Alli), FDA approved for adolescents 12-16 years old since 2003, limits intestinal fat absorption and as a result often produces unwanted GI effects. Phentermine’s approval for older adolescents dates from 1959 and has a weak evidence base, its label limits it to “short-term” use that’s generally taken to mean a maximum of 12 weeks. And, as a stimulant, phentermine has often been regarded as potentially dangerous, although Dr. Kelly noted that stimulants are well-accepted treatments for other disorders in children and adolescents.
“The earlier we treat obesity in youth, the better, given that it tends to track into adulthood,” agreed Dr. Caprio. “However, it remains to be seen whether weight reduction with a pharmacological agent is going to help prevent the intractable trajectories of weight and its complications. So far, it looks like surgery may be more efficacious,” she said in an interview.
Another drawback for the near future with liraglutide will likely be its cost for many patients, more than $10,000/year at full retail prices for the weight-loss formulation, given that insurers have had a poor record of covering the drug for this indication in adults, both Dr. Caprio and Dr. Kelly noted.
Compliance with liraglutide is also important. Dr. Kelly’s study followed patients for their first 26 weeks off treatment after 56 weeks on the drug, and showed that on average weights rebounded to virtually baseline levels by 6 months after treatment stopped.
Obesity treatment lasts a lifetime
“Obesity is a chronic disease, that requires chronic treatment, just like hypertension,” Dr. Kelly stressed, and cited the rebound seen in his study when liraglutide stopped as further proof of that concept. “All obesity treatment is lifelong,” he maintained.
He highlighted the importance of clinicians discussing with adolescent patients and their families the prospect of potentially remaining on liraglutide treatment for years to maintain weight loss. His experience with the randomized study convinced him that many adolescents with obesity are amenable to daily subcutaneous injection using the pen device that liraglutide comes in, but he acknowledged that some teens find this off-putting.
For the near term, Dr. Kelly foresaw liraglutide treatment of adolescents as something that will mostly be administered to patients who seek care at centers that specialize in obesity management. “I’ll think we’ll eventually see it move to more primary care settings, but that will be down the road.”
The study of liraglutide in adolescents was sponsored by Novo Nordisk, the company that markets liraglutide (Saxenda). Dr. Kelly has been a consultant to Novo Nordisk and also to Orexigen Therapeutics, Vivus, and WW, and he has received research funding from AstraZeneca. Dr. Caprio had no disclosures.
The Food and Drug Administration’s new indication for liraglutide (Saxenda) for weight loss in adolescents with obesity, announced on Dec. 4, received welcome as a milestone for advancing a field that’s seen no new drug options since 2003 and boosted by 50% the list of agents indicated for weight loss in this age group.
But liraglutide’s track record in adolescents in the key study published earlier in 2020 left some experts unconvinced that liraglutide’s modest effects would have much impact on blunting the expanding cohort of teens who are obese.
“Until now, we’ve had phentermine and orlistat with FDA approval” for adolescents with obesity, and phentermine’s label specifies only patients older than 16 years. “It’s important that the FDA deemed liraglutide’s benefits greater than its risks for adolescents,” said Aaron S. Kelly, PhD, leader of the 82-week, multicenter, randomized study of liraglutide in 251 adolescents with obesity that directly led to the FDA’s action.
“We have results from a strong, published randomized trial, and the green light from the FDA, and that should give clinicians reassurance and confidence to use liraglutide clinically,” said Dr. Kelly, professor of pediatrics and codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota in Minneapolis.
An ‘unimpressive’ drop in BMI
Sonia Caprio, MD, had a more skeptical take on liraglutide’s role with its new indication: “Approval of higher-dose liraglutide is an improvement that reflects a willingness to accept adolescent obesity as a disease that needs treatment with pharmacological agents. However, the study, published in New England Journal of Medicine, was not impressive in terms of weight loss, and more importantly liraglutide was not associated with any significant changes in metabolic markers” such as insulin resistance, high-sensitivity C-reactive protein, lipoproteins and triglycerides, and hemoglobin A1c.
The observed average 5% drop in body mass index seen after a year on liraglutide treatment, compared with baseline and relative to no average change from baseline in the placebo arm, was “totally insufficient, and will not diminish any of the metabolic complications in youth with obesity,” commented Dr. Caprio, an endocrinologist and professor of pediatrics at Yale University in New Haven, Conn.
Results from the study led by Dr. Kelly also showed that liraglutide for 56 weeks cut BMI by 5% in 43% of patients, and by 10% in 26%, compared with respective rates of 19% and 8% among those in the placebo-control arm. He took a more expansive view of the potential benefits from weight loss of the caliber demonstrated by liraglutide in the study.
“In general, we wait too long with obesity in children; the earlier the intervention the better. A 3% or 4% reduction in BMI at 12 or 13 years old can pay big dividends down the road” when a typical adolescent trajectory of steadily rising weight can be flattened, he said in an interview.
Bariatric and metabolic surgery, although highly effective and usually safe, is seen by many clinicians, patients, and families as an “intervention of last resort,” and its very low level of uptake in adolescents bears witness to that reputation. It also creates an important niche for safe and effective drugs to fill as an adjunct to lifestyle changes, which are often ineffective when used by themselves. Liraglutide’s main mechanism for weight loss is depressing hunger, Dr. Kelly noted.
Existing meds have limitations
The existing medical treatments, orlistat and phentermine, both have significant drawbacks that limit their use. Orlistat (Xenical, Alli), FDA approved for adolescents 12-16 years old since 2003, limits intestinal fat absorption and as a result often produces unwanted GI effects. Phentermine’s approval for older adolescents dates from 1959 and has a weak evidence base, its label limits it to “short-term” use that’s generally taken to mean a maximum of 12 weeks. And, as a stimulant, phentermine has often been regarded as potentially dangerous, although Dr. Kelly noted that stimulants are well-accepted treatments for other disorders in children and adolescents.
“The earlier we treat obesity in youth, the better, given that it tends to track into adulthood,” agreed Dr. Caprio. “However, it remains to be seen whether weight reduction with a pharmacological agent is going to help prevent the intractable trajectories of weight and its complications. So far, it looks like surgery may be more efficacious,” she said in an interview.
Another drawback for the near future with liraglutide will likely be its cost for many patients, more than $10,000/year at full retail prices for the weight-loss formulation, given that insurers have had a poor record of covering the drug for this indication in adults, both Dr. Caprio and Dr. Kelly noted.
Compliance with liraglutide is also important. Dr. Kelly’s study followed patients for their first 26 weeks off treatment after 56 weeks on the drug, and showed that on average weights rebounded to virtually baseline levels by 6 months after treatment stopped.
Obesity treatment lasts a lifetime
“Obesity is a chronic disease, that requires chronic treatment, just like hypertension,” Dr. Kelly stressed, and cited the rebound seen in his study when liraglutide stopped as further proof of that concept. “All obesity treatment is lifelong,” he maintained.
He highlighted the importance of clinicians discussing with adolescent patients and their families the prospect of potentially remaining on liraglutide treatment for years to maintain weight loss. His experience with the randomized study convinced him that many adolescents with obesity are amenable to daily subcutaneous injection using the pen device that liraglutide comes in, but he acknowledged that some teens find this off-putting.
For the near term, Dr. Kelly foresaw liraglutide treatment of adolescents as something that will mostly be administered to patients who seek care at centers that specialize in obesity management. “I’ll think we’ll eventually see it move to more primary care settings, but that will be down the road.”
The study of liraglutide in adolescents was sponsored by Novo Nordisk, the company that markets liraglutide (Saxenda). Dr. Kelly has been a consultant to Novo Nordisk and also to Orexigen Therapeutics, Vivus, and WW, and he has received research funding from AstraZeneca. Dr. Caprio had no disclosures.
The Food and Drug Administration’s new indication for liraglutide (Saxenda) for weight loss in adolescents with obesity, announced on Dec. 4, received welcome as a milestone for advancing a field that’s seen no new drug options since 2003 and boosted by 50% the list of agents indicated for weight loss in this age group.
But liraglutide’s track record in adolescents in the key study published earlier in 2020 left some experts unconvinced that liraglutide’s modest effects would have much impact on blunting the expanding cohort of teens who are obese.
“Until now, we’ve had phentermine and orlistat with FDA approval” for adolescents with obesity, and phentermine’s label specifies only patients older than 16 years. “It’s important that the FDA deemed liraglutide’s benefits greater than its risks for adolescents,” said Aaron S. Kelly, PhD, leader of the 82-week, multicenter, randomized study of liraglutide in 251 adolescents with obesity that directly led to the FDA’s action.
“We have results from a strong, published randomized trial, and the green light from the FDA, and that should give clinicians reassurance and confidence to use liraglutide clinically,” said Dr. Kelly, professor of pediatrics and codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota in Minneapolis.
An ‘unimpressive’ drop in BMI
Sonia Caprio, MD, had a more skeptical take on liraglutide’s role with its new indication: “Approval of higher-dose liraglutide is an improvement that reflects a willingness to accept adolescent obesity as a disease that needs treatment with pharmacological agents. However, the study, published in New England Journal of Medicine, was not impressive in terms of weight loss, and more importantly liraglutide was not associated with any significant changes in metabolic markers” such as insulin resistance, high-sensitivity C-reactive protein, lipoproteins and triglycerides, and hemoglobin A1c.
The observed average 5% drop in body mass index seen after a year on liraglutide treatment, compared with baseline and relative to no average change from baseline in the placebo arm, was “totally insufficient, and will not diminish any of the metabolic complications in youth with obesity,” commented Dr. Caprio, an endocrinologist and professor of pediatrics at Yale University in New Haven, Conn.
Results from the study led by Dr. Kelly also showed that liraglutide for 56 weeks cut BMI by 5% in 43% of patients, and by 10% in 26%, compared with respective rates of 19% and 8% among those in the placebo-control arm. He took a more expansive view of the potential benefits from weight loss of the caliber demonstrated by liraglutide in the study.
“In general, we wait too long with obesity in children; the earlier the intervention the better. A 3% or 4% reduction in BMI at 12 or 13 years old can pay big dividends down the road” when a typical adolescent trajectory of steadily rising weight can be flattened, he said in an interview.
Bariatric and metabolic surgery, although highly effective and usually safe, is seen by many clinicians, patients, and families as an “intervention of last resort,” and its very low level of uptake in adolescents bears witness to that reputation. It also creates an important niche for safe and effective drugs to fill as an adjunct to lifestyle changes, which are often ineffective when used by themselves. Liraglutide’s main mechanism for weight loss is depressing hunger, Dr. Kelly noted.
Existing meds have limitations
The existing medical treatments, orlistat and phentermine, both have significant drawbacks that limit their use. Orlistat (Xenical, Alli), FDA approved for adolescents 12-16 years old since 2003, limits intestinal fat absorption and as a result often produces unwanted GI effects. Phentermine’s approval for older adolescents dates from 1959 and has a weak evidence base, its label limits it to “short-term” use that’s generally taken to mean a maximum of 12 weeks. And, as a stimulant, phentermine has often been regarded as potentially dangerous, although Dr. Kelly noted that stimulants are well-accepted treatments for other disorders in children and adolescents.
“The earlier we treat obesity in youth, the better, given that it tends to track into adulthood,” agreed Dr. Caprio. “However, it remains to be seen whether weight reduction with a pharmacological agent is going to help prevent the intractable trajectories of weight and its complications. So far, it looks like surgery may be more efficacious,” she said in an interview.
Another drawback for the near future with liraglutide will likely be its cost for many patients, more than $10,000/year at full retail prices for the weight-loss formulation, given that insurers have had a poor record of covering the drug for this indication in adults, both Dr. Caprio and Dr. Kelly noted.
Compliance with liraglutide is also important. Dr. Kelly’s study followed patients for their first 26 weeks off treatment after 56 weeks on the drug, and showed that on average weights rebounded to virtually baseline levels by 6 months after treatment stopped.
Obesity treatment lasts a lifetime
“Obesity is a chronic disease, that requires chronic treatment, just like hypertension,” Dr. Kelly stressed, and cited the rebound seen in his study when liraglutide stopped as further proof of that concept. “All obesity treatment is lifelong,” he maintained.
He highlighted the importance of clinicians discussing with adolescent patients and their families the prospect of potentially remaining on liraglutide treatment for years to maintain weight loss. His experience with the randomized study convinced him that many adolescents with obesity are amenable to daily subcutaneous injection using the pen device that liraglutide comes in, but he acknowledged that some teens find this off-putting.
For the near term, Dr. Kelly foresaw liraglutide treatment of adolescents as something that will mostly be administered to patients who seek care at centers that specialize in obesity management. “I’ll think we’ll eventually see it move to more primary care settings, but that will be down the road.”
The study of liraglutide in adolescents was sponsored by Novo Nordisk, the company that markets liraglutide (Saxenda). Dr. Kelly has been a consultant to Novo Nordisk and also to Orexigen Therapeutics, Vivus, and WW, and he has received research funding from AstraZeneca. Dr. Caprio had no disclosures.
Endoscopic intragastric balloon improved NASH parameters
Endoscopically placed intragastric balloons were safe and effective for managing nonalcoholic fatty liver disease (NAFLD), according to the findings of an open-label, prospective study of 21 patients.
Six months after balloon placement, nonalcoholic fatty liver disease activity scores (NAS) had improved in 18 of 20 biopsied patients (90%), with a median decrease of 3 points (range, 1-4 points). Magnetic resonance elastography showed that fibrosis had improved by 1.5 stages in half of patients (10 of 20). “Other than postprocedural pain (in 5% of patients), no serious adverse events were reported,” Fateh Bazerbachi, MD, of Massachusetts General Hospital in Boston, and associates wrote in Clinical Gastroenterology and Hepatology.
Nonalcoholic fatty liver disease affects approximately 70% of obese adults and half of obese children, meaning that tens of millions of individuals are affected in the United States alone. Lifestyle changes rarely induce more than 10% body weight loss, the threshold for “meaningful improvement in NASH,” and bariatric surgery is not recommended for managing mild or moderate obesity and often is not desired by patients who do qualify, the researchers noted. “Endoscopic bariatric therapies are garnering more attention as potential strategies to address these shortcomings in obesity care and its comorbidities [, but] their influences on the driving and prognostic parameters of NAFLD remain unclear.”
In all, 81% of the study participants were women, with a mean age of 54 years and an average body mass index (BMI) of 44 kg/m2. At baseline, more than half had NAS scores of 4 or 5 and histologic fibrosis scores of 2 or 3. Baseline hemoglobin A1c levels averaged 7.4% (range, 5.1%-11.1%) and 29% of patients had impaired glucose tolerance. After receiving endoscopic ultrasound (EUS)–guided core liver biopsies, patients received an endoscopically placed fluid-filled intragastric balloon (Orbera, Apollo Endosurgery, Austin, Tex.). The balloon was removed 6 months later and magnetic resonance elastography and a second core biopsy were performed. One patient did not receive an exit biopsy (because of starting antithrombotic therapy) and thus was excluded from the final analysis.
Of 20 patients, 16 (80%) had at least a two-point improvement in NAS at 6 months, and half had NAS scores of less than 2, indicating remission of NASH. Three of 20 patients (15%) showed improvements in mild fibrosis, 12 showed no change, and 5 showed worsening. Patients lost an average of 11.7% of body weight (standard deviation, 7.7%; P = .01), BMI dropped by a mean of 5.2 (SD, 0.75; P = .01) and A1c fell by an average of 1.3% (SD, 0.5%; P = .02). Waist circumference also decreased significantly (mean, –14.4 cm; SD, –2.2 cm; P = .001), as did hip circumference, fasting glucose, AST, ALT, and AST-to-platelet ratio index. “Percent total body weight loss did not correlate with reductions in NAS or fibrosis,” the researchers noted.
Together, these findings suggest that intragastric balloon placement “may allow a reversal in the natural history of NAFLD and NASH, despite the short duration of the intervention,” they concluded. “The logistics of IGB [intragastric balloon] placement will enable accurate risk stratification of these patients in a safe and reproducible manner, obviating the need for additional investigations, and clarifying the real risk of patients afflicted with NAFLD.”
Apollo Endosurgery provided intragastric balloons, and Medtronic provided SharkCore needles. The senior author and two coinvestigators disclosed ties to Apollo Endosurgery, Medtronic, Metamodix, Boston Scientific, Cairn Diagnostics, Aspire Bariatrics, Johnson and Johnson, AstraZeneca, Genfit, Gila Therapeutics, and several other companies. The other investigators reported having no conflicts of interest.
SOURCE: Bazerbachi F et al. Clin Gastroenterol Hepatol. 2020 Apr 30. doi: 10.1016/j.cgh.2020.04.068.
Obesity a well-known risk factor for the development of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis, the latter of which is expected to become the leading indication for liver transplantation. As such addressing the steatosis in these patients is critical. A drop of even 5%-10% of total body weight with diet and exercise can result in significant improvement in liver disease.
In this article, Dr. Bazerbachi and colleagues work to advance the case for intragastric balloons as a successful treatment option for NAFLD. They performed a prospective, open-label study on 21 patients treated with an intragastric balloon for 6 months. Using gold-standard histology and noninvasive magnetic resonance elastography before and after therapy, they show significant improvement in NAFLD activity score (median change, 3 points; range, 1-4) over a short duration of treatment. Interestingly, the collection of the liver biopsy sample is done via endoscopic ultrasound, which can be easily performed during placement and removal of this intragastric balloon. While promising, follow-up studies are needed to show sustained improvement in NAFLD after the balloon is removed.
Wasif M. Abidi, MD, PhD, is assistant professor of medicine, gastroenterology, Baylor College of Medicine, Houston.
Obesity a well-known risk factor for the development of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis, the latter of which is expected to become the leading indication for liver transplantation. As such addressing the steatosis in these patients is critical. A drop of even 5%-10% of total body weight with diet and exercise can result in significant improvement in liver disease.
In this article, Dr. Bazerbachi and colleagues work to advance the case for intragastric balloons as a successful treatment option for NAFLD. They performed a prospective, open-label study on 21 patients treated with an intragastric balloon for 6 months. Using gold-standard histology and noninvasive magnetic resonance elastography before and after therapy, they show significant improvement in NAFLD activity score (median change, 3 points; range, 1-4) over a short duration of treatment. Interestingly, the collection of the liver biopsy sample is done via endoscopic ultrasound, which can be easily performed during placement and removal of this intragastric balloon. While promising, follow-up studies are needed to show sustained improvement in NAFLD after the balloon is removed.
Wasif M. Abidi, MD, PhD, is assistant professor of medicine, gastroenterology, Baylor College of Medicine, Houston.
Obesity a well-known risk factor for the development of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis, the latter of which is expected to become the leading indication for liver transplantation. As such addressing the steatosis in these patients is critical. A drop of even 5%-10% of total body weight with diet and exercise can result in significant improvement in liver disease.
In this article, Dr. Bazerbachi and colleagues work to advance the case for intragastric balloons as a successful treatment option for NAFLD. They performed a prospective, open-label study on 21 patients treated with an intragastric balloon for 6 months. Using gold-standard histology and noninvasive magnetic resonance elastography before and after therapy, they show significant improvement in NAFLD activity score (median change, 3 points; range, 1-4) over a short duration of treatment. Interestingly, the collection of the liver biopsy sample is done via endoscopic ultrasound, which can be easily performed during placement and removal of this intragastric balloon. While promising, follow-up studies are needed to show sustained improvement in NAFLD after the balloon is removed.
Wasif M. Abidi, MD, PhD, is assistant professor of medicine, gastroenterology, Baylor College of Medicine, Houston.
Endoscopically placed intragastric balloons were safe and effective for managing nonalcoholic fatty liver disease (NAFLD), according to the findings of an open-label, prospective study of 21 patients.
Six months after balloon placement, nonalcoholic fatty liver disease activity scores (NAS) had improved in 18 of 20 biopsied patients (90%), with a median decrease of 3 points (range, 1-4 points). Magnetic resonance elastography showed that fibrosis had improved by 1.5 stages in half of patients (10 of 20). “Other than postprocedural pain (in 5% of patients), no serious adverse events were reported,” Fateh Bazerbachi, MD, of Massachusetts General Hospital in Boston, and associates wrote in Clinical Gastroenterology and Hepatology.
Nonalcoholic fatty liver disease affects approximately 70% of obese adults and half of obese children, meaning that tens of millions of individuals are affected in the United States alone. Lifestyle changes rarely induce more than 10% body weight loss, the threshold for “meaningful improvement in NASH,” and bariatric surgery is not recommended for managing mild or moderate obesity and often is not desired by patients who do qualify, the researchers noted. “Endoscopic bariatric therapies are garnering more attention as potential strategies to address these shortcomings in obesity care and its comorbidities [, but] their influences on the driving and prognostic parameters of NAFLD remain unclear.”
In all, 81% of the study participants were women, with a mean age of 54 years and an average body mass index (BMI) of 44 kg/m2. At baseline, more than half had NAS scores of 4 or 5 and histologic fibrosis scores of 2 or 3. Baseline hemoglobin A1c levels averaged 7.4% (range, 5.1%-11.1%) and 29% of patients had impaired glucose tolerance. After receiving endoscopic ultrasound (EUS)–guided core liver biopsies, patients received an endoscopically placed fluid-filled intragastric balloon (Orbera, Apollo Endosurgery, Austin, Tex.). The balloon was removed 6 months later and magnetic resonance elastography and a second core biopsy were performed. One patient did not receive an exit biopsy (because of starting antithrombotic therapy) and thus was excluded from the final analysis.
Of 20 patients, 16 (80%) had at least a two-point improvement in NAS at 6 months, and half had NAS scores of less than 2, indicating remission of NASH. Three of 20 patients (15%) showed improvements in mild fibrosis, 12 showed no change, and 5 showed worsening. Patients lost an average of 11.7% of body weight (standard deviation, 7.7%; P = .01), BMI dropped by a mean of 5.2 (SD, 0.75; P = .01) and A1c fell by an average of 1.3% (SD, 0.5%; P = .02). Waist circumference also decreased significantly (mean, –14.4 cm; SD, –2.2 cm; P = .001), as did hip circumference, fasting glucose, AST, ALT, and AST-to-platelet ratio index. “Percent total body weight loss did not correlate with reductions in NAS or fibrosis,” the researchers noted.
Together, these findings suggest that intragastric balloon placement “may allow a reversal in the natural history of NAFLD and NASH, despite the short duration of the intervention,” they concluded. “The logistics of IGB [intragastric balloon] placement will enable accurate risk stratification of these patients in a safe and reproducible manner, obviating the need for additional investigations, and clarifying the real risk of patients afflicted with NAFLD.”
Apollo Endosurgery provided intragastric balloons, and Medtronic provided SharkCore needles. The senior author and two coinvestigators disclosed ties to Apollo Endosurgery, Medtronic, Metamodix, Boston Scientific, Cairn Diagnostics, Aspire Bariatrics, Johnson and Johnson, AstraZeneca, Genfit, Gila Therapeutics, and several other companies. The other investigators reported having no conflicts of interest.
SOURCE: Bazerbachi F et al. Clin Gastroenterol Hepatol. 2020 Apr 30. doi: 10.1016/j.cgh.2020.04.068.
Endoscopically placed intragastric balloons were safe and effective for managing nonalcoholic fatty liver disease (NAFLD), according to the findings of an open-label, prospective study of 21 patients.
Six months after balloon placement, nonalcoholic fatty liver disease activity scores (NAS) had improved in 18 of 20 biopsied patients (90%), with a median decrease of 3 points (range, 1-4 points). Magnetic resonance elastography showed that fibrosis had improved by 1.5 stages in half of patients (10 of 20). “Other than postprocedural pain (in 5% of patients), no serious adverse events were reported,” Fateh Bazerbachi, MD, of Massachusetts General Hospital in Boston, and associates wrote in Clinical Gastroenterology and Hepatology.
Nonalcoholic fatty liver disease affects approximately 70% of obese adults and half of obese children, meaning that tens of millions of individuals are affected in the United States alone. Lifestyle changes rarely induce more than 10% body weight loss, the threshold for “meaningful improvement in NASH,” and bariatric surgery is not recommended for managing mild or moderate obesity and often is not desired by patients who do qualify, the researchers noted. “Endoscopic bariatric therapies are garnering more attention as potential strategies to address these shortcomings in obesity care and its comorbidities [, but] their influences on the driving and prognostic parameters of NAFLD remain unclear.”
In all, 81% of the study participants were women, with a mean age of 54 years and an average body mass index (BMI) of 44 kg/m2. At baseline, more than half had NAS scores of 4 or 5 and histologic fibrosis scores of 2 or 3. Baseline hemoglobin A1c levels averaged 7.4% (range, 5.1%-11.1%) and 29% of patients had impaired glucose tolerance. After receiving endoscopic ultrasound (EUS)–guided core liver biopsies, patients received an endoscopically placed fluid-filled intragastric balloon (Orbera, Apollo Endosurgery, Austin, Tex.). The balloon was removed 6 months later and magnetic resonance elastography and a second core biopsy were performed. One patient did not receive an exit biopsy (because of starting antithrombotic therapy) and thus was excluded from the final analysis.
Of 20 patients, 16 (80%) had at least a two-point improvement in NAS at 6 months, and half had NAS scores of less than 2, indicating remission of NASH. Three of 20 patients (15%) showed improvements in mild fibrosis, 12 showed no change, and 5 showed worsening. Patients lost an average of 11.7% of body weight (standard deviation, 7.7%; P = .01), BMI dropped by a mean of 5.2 (SD, 0.75; P = .01) and A1c fell by an average of 1.3% (SD, 0.5%; P = .02). Waist circumference also decreased significantly (mean, –14.4 cm; SD, –2.2 cm; P = .001), as did hip circumference, fasting glucose, AST, ALT, and AST-to-platelet ratio index. “Percent total body weight loss did not correlate with reductions in NAS or fibrosis,” the researchers noted.
Together, these findings suggest that intragastric balloon placement “may allow a reversal in the natural history of NAFLD and NASH, despite the short duration of the intervention,” they concluded. “The logistics of IGB [intragastric balloon] placement will enable accurate risk stratification of these patients in a safe and reproducible manner, obviating the need for additional investigations, and clarifying the real risk of patients afflicted with NAFLD.”
Apollo Endosurgery provided intragastric balloons, and Medtronic provided SharkCore needles. The senior author and two coinvestigators disclosed ties to Apollo Endosurgery, Medtronic, Metamodix, Boston Scientific, Cairn Diagnostics, Aspire Bariatrics, Johnson and Johnson, AstraZeneca, Genfit, Gila Therapeutics, and several other companies. The other investigators reported having no conflicts of interest.
SOURCE: Bazerbachi F et al. Clin Gastroenterol Hepatol. 2020 Apr 30. doi: 10.1016/j.cgh.2020.04.068.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Autologous fecal microbiota transplantation helped maintain weight loss after ‘green’ Mediterranean diet
A high-polyphenol, calorie-restricted Mediterranean diet supplemented with green tea and the Mankai strain of duckweed optimized the microbiome for autologous fecal microbiota transplantation, which maintained both weight loss and insulin sensitivity after the diet ended, according to the findings of a novel clinical trial.
Eight months after the diet ended, 17% of individuals in the autologous fecal microbiota transplantation (aFMT) group had regained weight, compared with 50% of those who received oral placebo (P = .02). Gains in weight circumference were 1.89 cm and 5.05 cm, respectively (P = .01), and changes in fasting insulin levels were 1.46 (standard deviation, 3.6 mIU/mL) and 1.64 mIU/mL (standard deviation, 4.7 mIU/mL; P = .04). Notably, aFMT did not achieve these results after weight loss on a typical Mediterranean diet, with or without calorie restriction. “Diet-induced weight loss can be preserved, along with glycemic control, for months after a diet via aFMT capsules. A high-polyphenols, green plant-based or Mankai diet better optimizes the microbiome for an aFMT procedure,” Ehud Rinott, an MD, PhD student at Ben-Gurion University of the Negev in Beer-Sheva, Israel, and his associates wrote in Gastroenterology.
Significant weight regain after dieting is common and undermines cardiometabolic strides. In animal studies, FMT from lean to obese individuals induces both weight loss and metabolic improvements, and limited data point to similar benefits in humans. However, allogenic FMT in humans raises safety concerns and “practical barriers,” Mr. Rinott and his associates noted. Hypothesizing that aFMT of microbiota obtained at nadir weight might prevent postdiet rebounds, they randomly assigned 294 obese or dyslipidemic adults (average age, 52 years) to receive the calorie-restricted “green” Mediterranean diet or a standard Mediterranean diet with or without calorie restrictions for 6 months. At this time, microbiota obtained from fecal samples were frozen in colorless, odorless oral capsules that were considered indistinguishable from placebo capsules. Ninety participants who had lost at least 3.5% of their body weight (average loss, 8.3 kg) were then rerandomized in a double-blinded manner to receive once-daily aFMT or placebo capsules during months 8 through 14.
In all, 96% of participants consumed at least 80% of the capsules, a high rate of compliance. No adverse events from aFMT were reported. Metagenomic sequencing and 16s ribosomal RNA sequencing showed that only the “green” Mediterranean diet induced significant alterations in the gut microbiome during the weight-loss phase. In a complementary study of obese mice, autologous transplantation of microbiota obtained at nadir weight confirmed that adding Mankai during weight loss helped protect against subsequent regain and loss of insulin sensitivity.
All diets in this study emphasized vegetables while reducing sugars, salt, dietary cholesterol, trans and saturated fats, and poultry, and omitting processed and red meats. The “green” and standard calorie-restricted Mediterranean diets both limited calories to 1,500-1,800 per day for men and 1,200-1,400 per day for women (women comprised only 9% of study participants). In these two diets, fats – mainly monounsaturated and polyunsaturated – made up 40% of calories (including 28 g walnuts per day, containing 440 mg polyphenols), while carbohydrates were limited to less than 40 g per day in the first 2 months and then gradually increased to 80 g per day. The green Mediterranean diet added 3-4 cups of green tea daily and a shake containing 100 g of Mankai, which provided another 800 mg of polyphenols. All participants received free gym memberships and were told to exercise throughout the study (aerobic exercise for 45-60 minutes three to four times weekly, and resistance exercise two to three times weekly).
Funders included the Israeli Science Foundation, Israeli Ministry of Health, Israel Ministry of Science and Technology, German Research Foundation, California Walnuts Commission, and others. Mr. Rinott had no conflicts. Three coinvestigators disclosed ties to CoreBiome, Hinoman, and Mybiotics.
SOURCE: Rinott E et al. Gastroenterology. 2020 Aug 25. doi: 10.1053/j.gastro.2020.08.041.
In their recent publication in Gastroenterology, Rinott and Youngster et al. investigated whether autologous transplantation of diet-modified microbiota, delivered through oral capsules, prevented weight regain in abdominally obese individuals that were subjected to dietary regimens to induce weight loss. Transplantation of one’s own fecal microbiota collected after a calorie-restricted green Mediterranean diet (containing extra polyphenols) seemed to maintain metabolic improvements in comparison to placebo treatments during weight regain.
Nordin M.J. Hanssen, MD, is in the department of internal medicine, school for cardiovascular diseases, faculty of health, medicine and life sciences, Maastricht University, Amsterdam. He has no conflicts of interest relevant to this publication.
In their recent publication in Gastroenterology, Rinott and Youngster et al. investigated whether autologous transplantation of diet-modified microbiota, delivered through oral capsules, prevented weight regain in abdominally obese individuals that were subjected to dietary regimens to induce weight loss. Transplantation of one’s own fecal microbiota collected after a calorie-restricted green Mediterranean diet (containing extra polyphenols) seemed to maintain metabolic improvements in comparison to placebo treatments during weight regain.
Nordin M.J. Hanssen, MD, is in the department of internal medicine, school for cardiovascular diseases, faculty of health, medicine and life sciences, Maastricht University, Amsterdam. He has no conflicts of interest relevant to this publication.
In their recent publication in Gastroenterology, Rinott and Youngster et al. investigated whether autologous transplantation of diet-modified microbiota, delivered through oral capsules, prevented weight regain in abdominally obese individuals that were subjected to dietary regimens to induce weight loss. Transplantation of one’s own fecal microbiota collected after a calorie-restricted green Mediterranean diet (containing extra polyphenols) seemed to maintain metabolic improvements in comparison to placebo treatments during weight regain.
Nordin M.J. Hanssen, MD, is in the department of internal medicine, school for cardiovascular diseases, faculty of health, medicine and life sciences, Maastricht University, Amsterdam. He has no conflicts of interest relevant to this publication.
A high-polyphenol, calorie-restricted Mediterranean diet supplemented with green tea and the Mankai strain of duckweed optimized the microbiome for autologous fecal microbiota transplantation, which maintained both weight loss and insulin sensitivity after the diet ended, according to the findings of a novel clinical trial.
Eight months after the diet ended, 17% of individuals in the autologous fecal microbiota transplantation (aFMT) group had regained weight, compared with 50% of those who received oral placebo (P = .02). Gains in weight circumference were 1.89 cm and 5.05 cm, respectively (P = .01), and changes in fasting insulin levels were 1.46 (standard deviation, 3.6 mIU/mL) and 1.64 mIU/mL (standard deviation, 4.7 mIU/mL; P = .04). Notably, aFMT did not achieve these results after weight loss on a typical Mediterranean diet, with or without calorie restriction. “Diet-induced weight loss can be preserved, along with glycemic control, for months after a diet via aFMT capsules. A high-polyphenols, green plant-based or Mankai diet better optimizes the microbiome for an aFMT procedure,” Ehud Rinott, an MD, PhD student at Ben-Gurion University of the Negev in Beer-Sheva, Israel, and his associates wrote in Gastroenterology.
Significant weight regain after dieting is common and undermines cardiometabolic strides. In animal studies, FMT from lean to obese individuals induces both weight loss and metabolic improvements, and limited data point to similar benefits in humans. However, allogenic FMT in humans raises safety concerns and “practical barriers,” Mr. Rinott and his associates noted. Hypothesizing that aFMT of microbiota obtained at nadir weight might prevent postdiet rebounds, they randomly assigned 294 obese or dyslipidemic adults (average age, 52 years) to receive the calorie-restricted “green” Mediterranean diet or a standard Mediterranean diet with or without calorie restrictions for 6 months. At this time, microbiota obtained from fecal samples were frozen in colorless, odorless oral capsules that were considered indistinguishable from placebo capsules. Ninety participants who had lost at least 3.5% of their body weight (average loss, 8.3 kg) were then rerandomized in a double-blinded manner to receive once-daily aFMT or placebo capsules during months 8 through 14.
In all, 96% of participants consumed at least 80% of the capsules, a high rate of compliance. No adverse events from aFMT were reported. Metagenomic sequencing and 16s ribosomal RNA sequencing showed that only the “green” Mediterranean diet induced significant alterations in the gut microbiome during the weight-loss phase. In a complementary study of obese mice, autologous transplantation of microbiota obtained at nadir weight confirmed that adding Mankai during weight loss helped protect against subsequent regain and loss of insulin sensitivity.
All diets in this study emphasized vegetables while reducing sugars, salt, dietary cholesterol, trans and saturated fats, and poultry, and omitting processed and red meats. The “green” and standard calorie-restricted Mediterranean diets both limited calories to 1,500-1,800 per day for men and 1,200-1,400 per day for women (women comprised only 9% of study participants). In these two diets, fats – mainly monounsaturated and polyunsaturated – made up 40% of calories (including 28 g walnuts per day, containing 440 mg polyphenols), while carbohydrates were limited to less than 40 g per day in the first 2 months and then gradually increased to 80 g per day. The green Mediterranean diet added 3-4 cups of green tea daily and a shake containing 100 g of Mankai, which provided another 800 mg of polyphenols. All participants received free gym memberships and were told to exercise throughout the study (aerobic exercise for 45-60 minutes three to four times weekly, and resistance exercise two to three times weekly).
Funders included the Israeli Science Foundation, Israeli Ministry of Health, Israel Ministry of Science and Technology, German Research Foundation, California Walnuts Commission, and others. Mr. Rinott had no conflicts. Three coinvestigators disclosed ties to CoreBiome, Hinoman, and Mybiotics.
SOURCE: Rinott E et al. Gastroenterology. 2020 Aug 25. doi: 10.1053/j.gastro.2020.08.041.
A high-polyphenol, calorie-restricted Mediterranean diet supplemented with green tea and the Mankai strain of duckweed optimized the microbiome for autologous fecal microbiota transplantation, which maintained both weight loss and insulin sensitivity after the diet ended, according to the findings of a novel clinical trial.
Eight months after the diet ended, 17% of individuals in the autologous fecal microbiota transplantation (aFMT) group had regained weight, compared with 50% of those who received oral placebo (P = .02). Gains in weight circumference were 1.89 cm and 5.05 cm, respectively (P = .01), and changes in fasting insulin levels were 1.46 (standard deviation, 3.6 mIU/mL) and 1.64 mIU/mL (standard deviation, 4.7 mIU/mL; P = .04). Notably, aFMT did not achieve these results after weight loss on a typical Mediterranean diet, with or without calorie restriction. “Diet-induced weight loss can be preserved, along with glycemic control, for months after a diet via aFMT capsules. A high-polyphenols, green plant-based or Mankai diet better optimizes the microbiome for an aFMT procedure,” Ehud Rinott, an MD, PhD student at Ben-Gurion University of the Negev in Beer-Sheva, Israel, and his associates wrote in Gastroenterology.
Significant weight regain after dieting is common and undermines cardiometabolic strides. In animal studies, FMT from lean to obese individuals induces both weight loss and metabolic improvements, and limited data point to similar benefits in humans. However, allogenic FMT in humans raises safety concerns and “practical barriers,” Mr. Rinott and his associates noted. Hypothesizing that aFMT of microbiota obtained at nadir weight might prevent postdiet rebounds, they randomly assigned 294 obese or dyslipidemic adults (average age, 52 years) to receive the calorie-restricted “green” Mediterranean diet or a standard Mediterranean diet with or without calorie restrictions for 6 months. At this time, microbiota obtained from fecal samples were frozen in colorless, odorless oral capsules that were considered indistinguishable from placebo capsules. Ninety participants who had lost at least 3.5% of their body weight (average loss, 8.3 kg) were then rerandomized in a double-blinded manner to receive once-daily aFMT or placebo capsules during months 8 through 14.
In all, 96% of participants consumed at least 80% of the capsules, a high rate of compliance. No adverse events from aFMT were reported. Metagenomic sequencing and 16s ribosomal RNA sequencing showed that only the “green” Mediterranean diet induced significant alterations in the gut microbiome during the weight-loss phase. In a complementary study of obese mice, autologous transplantation of microbiota obtained at nadir weight confirmed that adding Mankai during weight loss helped protect against subsequent regain and loss of insulin sensitivity.
All diets in this study emphasized vegetables while reducing sugars, salt, dietary cholesterol, trans and saturated fats, and poultry, and omitting processed and red meats. The “green” and standard calorie-restricted Mediterranean diets both limited calories to 1,500-1,800 per day for men and 1,200-1,400 per day for women (women comprised only 9% of study participants). In these two diets, fats – mainly monounsaturated and polyunsaturated – made up 40% of calories (including 28 g walnuts per day, containing 440 mg polyphenols), while carbohydrates were limited to less than 40 g per day in the first 2 months and then gradually increased to 80 g per day. The green Mediterranean diet added 3-4 cups of green tea daily and a shake containing 100 g of Mankai, which provided another 800 mg of polyphenols. All participants received free gym memberships and were told to exercise throughout the study (aerobic exercise for 45-60 minutes three to four times weekly, and resistance exercise two to three times weekly).
Funders included the Israeli Science Foundation, Israeli Ministry of Health, Israel Ministry of Science and Technology, German Research Foundation, California Walnuts Commission, and others. Mr. Rinott had no conflicts. Three coinvestigators disclosed ties to CoreBiome, Hinoman, and Mybiotics.
SOURCE: Rinott E et al. Gastroenterology. 2020 Aug 25. doi: 10.1053/j.gastro.2020.08.041.
FROM GASTROENTEROLOGY
FDA clears first drug for rare genetic causes of severe obesity
The Food and Drug Administration has approved setmelanotide (Imcivree, Rhythm Pharmaceuticals) for weight management in adults and children as young as 6 years with obesity because of proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing.
Individuals with these rare genetic causes of severe obesity have a normal weight at birth but develop persistent severe obesity within months because of insatiable hunger (hyperphagia).
Setmelanotide, a melanocortin-4 receptor (MC4R) agonist, is the first FDA-approved therapy for these disorders.
“Many patients and families who live with these diseases face an often-burdensome stigma associated with severe obesity. To manage this obesity and control disruptive food-seeking behavior, caregivers often lock cabinets and refrigerators and significantly limit social activities,” said Jennifer Miller, MD, a pediatric endocrinologist at University of Florida Health, Gainesville, in a press release issued by the company.
“This FDA approval marks an important turning point, providing a much needed therapy and supporting the use of genetic testing to identify and properly diagnose patients with these rare genetic diseases of obesity,” she noted.
David Meeker, MD, chair, president, and CEO of Rhythm Pharmaceuticals, added: “We are advancing a first-in-class, precision medicine that is designed to directly address the underlying cause of obesities driven by genetic deficits in the MC4R pathway.”
Setmelanotide was evaluated in two phase 3 clinical trials. In one trial, 80% of patients with obesity caused by POMC or PCSK1 deficiency achieved greater than 10% weight loss after 1 year of treatment.
In the other trial, 45.5% of patients with obesity caused by LEPR deficiency achieved greater than 10% weight loss with 1 year of treatment.
Results for the two trials were recently published in The Lancet Diabetes & Endocrinology and discussed at the ObesityWeek Interactive 2020 meeting.
Setmelanotide was generally well tolerated in both trials. The most common adverse events were injection-site reactions, skin hyperpigmentation, and nausea.
The drug label notes that disturbances in sexual arousal, depression, and suicidal ideation; skin pigmentation; and darkening of preexisting nevi may occur with setmelanotide treatment.
The drug label also notes a risk for serious adverse reactions because of benzyl alcohol preservative in neonates and low-birth-weight infants. Setmelanotide is not approved for use in neonates or infants.
The company expects the drug to be commercially available in the United States in the first quarter of 2021.
Setmelanotide for the treatment of obesity associated with rare genetic defects had FDA breakthrough therapy designation as well as orphan drug designation.
The company is also evaluating setmelanotide for reduction in hunger and body weight in a pivotal phase 3 trial in people living with Bardet-Biedl or Alström syndrome, and top-line data are due soon.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration has approved setmelanotide (Imcivree, Rhythm Pharmaceuticals) for weight management in adults and children as young as 6 years with obesity because of proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing.
Individuals with these rare genetic causes of severe obesity have a normal weight at birth but develop persistent severe obesity within months because of insatiable hunger (hyperphagia).
Setmelanotide, a melanocortin-4 receptor (MC4R) agonist, is the first FDA-approved therapy for these disorders.
“Many patients and families who live with these diseases face an often-burdensome stigma associated with severe obesity. To manage this obesity and control disruptive food-seeking behavior, caregivers often lock cabinets and refrigerators and significantly limit social activities,” said Jennifer Miller, MD, a pediatric endocrinologist at University of Florida Health, Gainesville, in a press release issued by the company.
“This FDA approval marks an important turning point, providing a much needed therapy and supporting the use of genetic testing to identify and properly diagnose patients with these rare genetic diseases of obesity,” she noted.
David Meeker, MD, chair, president, and CEO of Rhythm Pharmaceuticals, added: “We are advancing a first-in-class, precision medicine that is designed to directly address the underlying cause of obesities driven by genetic deficits in the MC4R pathway.”
Setmelanotide was evaluated in two phase 3 clinical trials. In one trial, 80% of patients with obesity caused by POMC or PCSK1 deficiency achieved greater than 10% weight loss after 1 year of treatment.
In the other trial, 45.5% of patients with obesity caused by LEPR deficiency achieved greater than 10% weight loss with 1 year of treatment.
Results for the two trials were recently published in The Lancet Diabetes & Endocrinology and discussed at the ObesityWeek Interactive 2020 meeting.
Setmelanotide was generally well tolerated in both trials. The most common adverse events were injection-site reactions, skin hyperpigmentation, and nausea.
The drug label notes that disturbances in sexual arousal, depression, and suicidal ideation; skin pigmentation; and darkening of preexisting nevi may occur with setmelanotide treatment.
The drug label also notes a risk for serious adverse reactions because of benzyl alcohol preservative in neonates and low-birth-weight infants. Setmelanotide is not approved for use in neonates or infants.
The company expects the drug to be commercially available in the United States in the first quarter of 2021.
Setmelanotide for the treatment of obesity associated with rare genetic defects had FDA breakthrough therapy designation as well as orphan drug designation.
The company is also evaluating setmelanotide for reduction in hunger and body weight in a pivotal phase 3 trial in people living with Bardet-Biedl or Alström syndrome, and top-line data are due soon.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration has approved setmelanotide (Imcivree, Rhythm Pharmaceuticals) for weight management in adults and children as young as 6 years with obesity because of proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing.
Individuals with these rare genetic causes of severe obesity have a normal weight at birth but develop persistent severe obesity within months because of insatiable hunger (hyperphagia).
Setmelanotide, a melanocortin-4 receptor (MC4R) agonist, is the first FDA-approved therapy for these disorders.
“Many patients and families who live with these diseases face an often-burdensome stigma associated with severe obesity. To manage this obesity and control disruptive food-seeking behavior, caregivers often lock cabinets and refrigerators and significantly limit social activities,” said Jennifer Miller, MD, a pediatric endocrinologist at University of Florida Health, Gainesville, in a press release issued by the company.
“This FDA approval marks an important turning point, providing a much needed therapy and supporting the use of genetic testing to identify and properly diagnose patients with these rare genetic diseases of obesity,” she noted.
David Meeker, MD, chair, president, and CEO of Rhythm Pharmaceuticals, added: “We are advancing a first-in-class, precision medicine that is designed to directly address the underlying cause of obesities driven by genetic deficits in the MC4R pathway.”
Setmelanotide was evaluated in two phase 3 clinical trials. In one trial, 80% of patients with obesity caused by POMC or PCSK1 deficiency achieved greater than 10% weight loss after 1 year of treatment.
In the other trial, 45.5% of patients with obesity caused by LEPR deficiency achieved greater than 10% weight loss with 1 year of treatment.
Results for the two trials were recently published in The Lancet Diabetes & Endocrinology and discussed at the ObesityWeek Interactive 2020 meeting.
Setmelanotide was generally well tolerated in both trials. The most common adverse events were injection-site reactions, skin hyperpigmentation, and nausea.
The drug label notes that disturbances in sexual arousal, depression, and suicidal ideation; skin pigmentation; and darkening of preexisting nevi may occur with setmelanotide treatment.
The drug label also notes a risk for serious adverse reactions because of benzyl alcohol preservative in neonates and low-birth-weight infants. Setmelanotide is not approved for use in neonates or infants.
The company expects the drug to be commercially available in the United States in the first quarter of 2021.
Setmelanotide for the treatment of obesity associated with rare genetic defects had FDA breakthrough therapy designation as well as orphan drug designation.
The company is also evaluating setmelanotide for reduction in hunger and body weight in a pivotal phase 3 trial in people living with Bardet-Biedl or Alström syndrome, and top-line data are due soon.
A version of this article originally appeared on Medscape.com.
Age no barrier to weight loss in those with morbid obesity
Older adults should be recommended for hospital-based lifestyle interventions to reduce weight, say U.K. investigators after finding there was no difference in weight loss between older and younger individuals in their program for those with morbid obesity.
Thomas M. Barber, PhD, and colleagues looked back at nearly 250 randomly selected adults who attended their obesity service over an 11-year period.
Older individuals, defined as aged 60 years and over, had higher rates of type 2 diabetes but experienced a similar percentage weight loss and reduction in body mass index (BMI) as younger patients over the course of around 40 months.
“Age should be no barrier to lifestyle management of obesity,” said Dr. Barber, of University Hospitals Coventry (England) and Warwickshire, in a news release from his institution. “Rather than putting up barriers to older people accessing weight-loss programs, we should be proactively facilitating that process. To do otherwise would risk further and unnecessary neglect of older people through societal ageist misconceptions.”
He urged service providers and policy makers to “appreciate the importance of weight loss in older people with obesity for the maintenance of health and well-being and the facilitation of healthy aging. Furthermore, age per se should not contribute toward clinical decisions regarding the implementation of lifestyle management of older people.”
The research was published online Nov. 22 in Clinical Endocrinology.
Real-world data will inform clinical practice
Jason Halford, PhD, a professor of biological psychology and health behavior, said in an interview: “The fear is that older patients are perceived not to respond” to lifestyle interventions to control obesity, “and that’s clearly a fallacy, according to this study.”
The findings are strengthened by the fact that these are real-world data, “and so it will inform clinical practice,” he added.
And one of the “more interesting” findings was that [type 2] diabetes was “more prevalent” in the older group “but they’re still losing weight,” he noted.
“Traditionally it’s been thought that people with type 2 diabetes find it more difficult to lose weight because you’re trying to manage two conditions,” said Dr. Halford, of the University of Leeds (England), who is also president-elect of the European Association for the Study of Obesity.
Don’t discount older patients
The researchers note that many of the comorbidities associated with obesity “develop over time” and that “no one is immune to obesity,” regardless of their age, sex, ethnicity, and socioeconomic status.
Barber said there are “a number of reasons” why health care professionals “may discount weight loss in older people,” including “an ‘ageist’ perspective that weight-loss is not relevant to older people and misconceptions of reduced ability of older people to lose weight through dietary modification and increased exercise.”
And “older people may feel that hospital-based obesity services are not for them,” he noted.
To determine the effect of age on the ability to lose weight through lifestyle interventions, Dr. Barber and colleagues randomly selected 242 patients with morbid obesity who attended their hospital-based service between 2005 and 2016.
Of these, 167 were aged 18-60 years and 75 were aged 60 years and older. Most participants were women (75.4% of the younger patients and 60.0% of the older patients).
The proportion of patients with confirmed diabetes was markedly higher in the older group, compared with the younger group, at 62.7% versus 35.3%, although older patients had a significantly lower baseline BMI, at 46.9 versus 49.7 kg/m2 (P < .05).
The average duration of the lifestyle intervention was over 3 years (41.5 months) in the younger patients and 33.6 months in the older patients.
There was no significant difference in percentage weight loss between younger and older patients, at 6.9% and 7.3%, respectively, and no difference in percentage reduction in BMI, at 8.1% versus 7.8%.
Further analysis demonstrated that there was no significant correlation between age at referral to the hospital-based service and percentage weight loss (correlation coefficient, –0.13).
Dr. Halford said it would have been “useful” to know the proportion of patients achieving 5% and 10% weight loss because, if a third of patients lost more than 10% of their weight, “even in an elderly population, that would suggest there’d be real benefits in terms of things like type 2 diabetes,” he noted.
And he would like to have seen more data around how long participants had been struggling with obesity, as it’s “just an assumption that the second group is further down the path because they’re older, but we can’t be 100% sure.”
The team noted the study is limited by being retrospective and including a random selection of patients attending the service rather than the entire cohort.
Dr. Halford agreed but said the analysis is a “starting point” and could be used as a platform to conduct “much more systematic research on this area.”
No funding or relevant financial relationships were declared.
A version of this article originally appeared on Medscape.com.
Older adults should be recommended for hospital-based lifestyle interventions to reduce weight, say U.K. investigators after finding there was no difference in weight loss between older and younger individuals in their program for those with morbid obesity.
Thomas M. Barber, PhD, and colleagues looked back at nearly 250 randomly selected adults who attended their obesity service over an 11-year period.
Older individuals, defined as aged 60 years and over, had higher rates of type 2 diabetes but experienced a similar percentage weight loss and reduction in body mass index (BMI) as younger patients over the course of around 40 months.
“Age should be no barrier to lifestyle management of obesity,” said Dr. Barber, of University Hospitals Coventry (England) and Warwickshire, in a news release from his institution. “Rather than putting up barriers to older people accessing weight-loss programs, we should be proactively facilitating that process. To do otherwise would risk further and unnecessary neglect of older people through societal ageist misconceptions.”
He urged service providers and policy makers to “appreciate the importance of weight loss in older people with obesity for the maintenance of health and well-being and the facilitation of healthy aging. Furthermore, age per se should not contribute toward clinical decisions regarding the implementation of lifestyle management of older people.”
The research was published online Nov. 22 in Clinical Endocrinology.
Real-world data will inform clinical practice
Jason Halford, PhD, a professor of biological psychology and health behavior, said in an interview: “The fear is that older patients are perceived not to respond” to lifestyle interventions to control obesity, “and that’s clearly a fallacy, according to this study.”
The findings are strengthened by the fact that these are real-world data, “and so it will inform clinical practice,” he added.
And one of the “more interesting” findings was that [type 2] diabetes was “more prevalent” in the older group “but they’re still losing weight,” he noted.
“Traditionally it’s been thought that people with type 2 diabetes find it more difficult to lose weight because you’re trying to manage two conditions,” said Dr. Halford, of the University of Leeds (England), who is also president-elect of the European Association for the Study of Obesity.
Don’t discount older patients
The researchers note that many of the comorbidities associated with obesity “develop over time” and that “no one is immune to obesity,” regardless of their age, sex, ethnicity, and socioeconomic status.
Barber said there are “a number of reasons” why health care professionals “may discount weight loss in older people,” including “an ‘ageist’ perspective that weight-loss is not relevant to older people and misconceptions of reduced ability of older people to lose weight through dietary modification and increased exercise.”
And “older people may feel that hospital-based obesity services are not for them,” he noted.
To determine the effect of age on the ability to lose weight through lifestyle interventions, Dr. Barber and colleagues randomly selected 242 patients with morbid obesity who attended their hospital-based service between 2005 and 2016.
Of these, 167 were aged 18-60 years and 75 were aged 60 years and older. Most participants were women (75.4% of the younger patients and 60.0% of the older patients).
The proportion of patients with confirmed diabetes was markedly higher in the older group, compared with the younger group, at 62.7% versus 35.3%, although older patients had a significantly lower baseline BMI, at 46.9 versus 49.7 kg/m2 (P < .05).
The average duration of the lifestyle intervention was over 3 years (41.5 months) in the younger patients and 33.6 months in the older patients.
There was no significant difference in percentage weight loss between younger and older patients, at 6.9% and 7.3%, respectively, and no difference in percentage reduction in BMI, at 8.1% versus 7.8%.
Further analysis demonstrated that there was no significant correlation between age at referral to the hospital-based service and percentage weight loss (correlation coefficient, –0.13).
Dr. Halford said it would have been “useful” to know the proportion of patients achieving 5% and 10% weight loss because, if a third of patients lost more than 10% of their weight, “even in an elderly population, that would suggest there’d be real benefits in terms of things like type 2 diabetes,” he noted.
And he would like to have seen more data around how long participants had been struggling with obesity, as it’s “just an assumption that the second group is further down the path because they’re older, but we can’t be 100% sure.”
The team noted the study is limited by being retrospective and including a random selection of patients attending the service rather than the entire cohort.
Dr. Halford agreed but said the analysis is a “starting point” and could be used as a platform to conduct “much more systematic research on this area.”
No funding or relevant financial relationships were declared.
A version of this article originally appeared on Medscape.com.
Older adults should be recommended for hospital-based lifestyle interventions to reduce weight, say U.K. investigators after finding there was no difference in weight loss between older and younger individuals in their program for those with morbid obesity.
Thomas M. Barber, PhD, and colleagues looked back at nearly 250 randomly selected adults who attended their obesity service over an 11-year period.
Older individuals, defined as aged 60 years and over, had higher rates of type 2 diabetes but experienced a similar percentage weight loss and reduction in body mass index (BMI) as younger patients over the course of around 40 months.
“Age should be no barrier to lifestyle management of obesity,” said Dr. Barber, of University Hospitals Coventry (England) and Warwickshire, in a news release from his institution. “Rather than putting up barriers to older people accessing weight-loss programs, we should be proactively facilitating that process. To do otherwise would risk further and unnecessary neglect of older people through societal ageist misconceptions.”
He urged service providers and policy makers to “appreciate the importance of weight loss in older people with obesity for the maintenance of health and well-being and the facilitation of healthy aging. Furthermore, age per se should not contribute toward clinical decisions regarding the implementation of lifestyle management of older people.”
The research was published online Nov. 22 in Clinical Endocrinology.
Real-world data will inform clinical practice
Jason Halford, PhD, a professor of biological psychology and health behavior, said in an interview: “The fear is that older patients are perceived not to respond” to lifestyle interventions to control obesity, “and that’s clearly a fallacy, according to this study.”
The findings are strengthened by the fact that these are real-world data, “and so it will inform clinical practice,” he added.
And one of the “more interesting” findings was that [type 2] diabetes was “more prevalent” in the older group “but they’re still losing weight,” he noted.
“Traditionally it’s been thought that people with type 2 diabetes find it more difficult to lose weight because you’re trying to manage two conditions,” said Dr. Halford, of the University of Leeds (England), who is also president-elect of the European Association for the Study of Obesity.
Don’t discount older patients
The researchers note that many of the comorbidities associated with obesity “develop over time” and that “no one is immune to obesity,” regardless of their age, sex, ethnicity, and socioeconomic status.
Barber said there are “a number of reasons” why health care professionals “may discount weight loss in older people,” including “an ‘ageist’ perspective that weight-loss is not relevant to older people and misconceptions of reduced ability of older people to lose weight through dietary modification and increased exercise.”
And “older people may feel that hospital-based obesity services are not for them,” he noted.
To determine the effect of age on the ability to lose weight through lifestyle interventions, Dr. Barber and colleagues randomly selected 242 patients with morbid obesity who attended their hospital-based service between 2005 and 2016.
Of these, 167 were aged 18-60 years and 75 were aged 60 years and older. Most participants were women (75.4% of the younger patients and 60.0% of the older patients).
The proportion of patients with confirmed diabetes was markedly higher in the older group, compared with the younger group, at 62.7% versus 35.3%, although older patients had a significantly lower baseline BMI, at 46.9 versus 49.7 kg/m2 (P < .05).
The average duration of the lifestyle intervention was over 3 years (41.5 months) in the younger patients and 33.6 months in the older patients.
There was no significant difference in percentage weight loss between younger and older patients, at 6.9% and 7.3%, respectively, and no difference in percentage reduction in BMI, at 8.1% versus 7.8%.
Further analysis demonstrated that there was no significant correlation between age at referral to the hospital-based service and percentage weight loss (correlation coefficient, –0.13).
Dr. Halford said it would have been “useful” to know the proportion of patients achieving 5% and 10% weight loss because, if a third of patients lost more than 10% of their weight, “even in an elderly population, that would suggest there’d be real benefits in terms of things like type 2 diabetes,” he noted.
And he would like to have seen more data around how long participants had been struggling with obesity, as it’s “just an assumption that the second group is further down the path because they’re older, but we can’t be 100% sure.”
The team noted the study is limited by being retrospective and including a random selection of patients attending the service rather than the entire cohort.
Dr. Halford agreed but said the analysis is a “starting point” and could be used as a platform to conduct “much more systematic research on this area.”
No funding or relevant financial relationships were declared.
A version of this article originally appeared on Medscape.com.
Obesity phenotyping matches patients with more effective interventions
A phenotype-guided strategy for systematically matching weight-loss patients to their potentially ideal weight-loss drug roughly doubled treatment efficacy, compared with usual practice, in a single-center, randomized study with 268 patients.
In contrast, in 200 patients who received weight loss–drug therapy selected by routine means, 35% achieved greater than 10% loss compared with their starting weight, Andres J. Acosta, MD, said at the virtual ObesityWeek® Interactive 2020 meeting.
The phenotype-guided strategy also led to an average 16% weight loss from baseline after 12 months, compared with a 9% average loss among the usual-care controls, reported Dr. Acosta, a gastroenterologist at the Mayo Clinic in Rochester, Minn.
A “one-size-fits-all approach to weight loss treatment is not working,” he declared. “Our long-term goal is to develop a personalized approach to obesity management.”
Personalized weight loss treatment isn’t new
“The better we can match treatment to a patient’s needs, the more likely it will succeed. That’s not a brand new idea. They are trying to standardize the way that we classify the disorders that play a role in why a person gains weight or has trouble losing weight,” commented John D. Clark III, MD, an internal medicine physician and weight-management specialist at UT Southwestern Medical Center in Dallas.
The increased weight loss levels that Dr. Acosta reported in patients who underwent the study’s phenotyping protocol and received tailored treatment “are similar to the numbers we see when a patient’s treatment is the right fit for them. You see weight loss in these ranges,” Dr. Clark said in an interview.
The study run by Dr. Acosta and his associates consisted of two phases. First, they established normal and abnormal ranges for four different obesity phenotypes by studying 100 patients with obesity. The patients underwent an extensive and uniform workup designed to classify their obesity phenotype.
Four obesity phenotypes
The researchers categorized patients into one of four types:
- Disordered initial eating satiation, called ‘hungry brain,” and assessed by measuring food intake at a buffet, ad libidum meal.
- Disordered maintenance of satiety, called “hungry gut,” assessed by both a gastric-emptying study as well as patient self-assessment for postprandial fullness.
- “Emotional hunger,” assessed with two questionnaires.
- Disordered energy expenditure, called “slow burn,” assessed by measuring basal metabolic rate, and self-reports of both exercise and nonexercise activity.
Dr. Acosta estimated that the complete workup to assess all four potential phenotypes costs about $1,200.
The researchers then applied the 75th percentile value from each of these assessments to 450 patients with obesity in their clinic to see the prevalence of the four phenotypes. They identified a single phenotype in 58% of these patients, including 18% with hungry gut, 16% with hungry brain, 12% with emotional hunger, and 12% with slow burn. An additional 27% of the patients were positive for two or more phenotypes (including 9% who were positive for all four phenotypes), and 15% did not test positive for any of the four phenotypes.
Phenotype-guided treatments
They then applied their findings in a prospective randomized study that matched a drug intervention to each of the four phenotypes during a year-long, comprehensive weight-loss program at the Mayo Clinic’s Weight Management Clinic. The study randomized 100 patients to the phenotype-driven arm, with 68 of these patients receiving their assigned drug, and 200 patients served as controls. Patients averaged about 47 years old, and their average body mass index was about 41 kg/m2.
The investigational arm included 30 patients classified as having a hungry brain, with 20 of these patients treated with phentermine plus topiramate and 10 treated with lorcaserin (before it was withdrawn by the Food and Drug Administration); 12 with hungry gut and treated with liraglutide (Saxenda); 19 with emotional hunger who received naltrexone SR/bupropion SR (Contrave); and seven with slow burn who received phentermine.
The control arm included 200 patients seeking weight loss treatment at Mayo who did not undergo phenotyping and received their drug treatment based on their personal preference in consultation with their Mayo physician. In this group, drug treatment broke down as 106 patients (53%) on phentermine plus topiramate, 41 (21%) on liraglutide, 34 (17%) on phentermine alone, 14 (7%) on naltrexone SR/bupropion SR, and 5 patients (3%) on locaserin (percentages total 101% because of rounding).
Overall, phenotyping led to more patients treated with naltrexone SR/buproprion SR and lorcaserin and fewer treated with phentermine or phentermine and topiramate ER. All patients were eligible to also receive behavioral interventions as needed.
“We do a lot of testing to identify the phenotype,” in addition to gathering additional clues from a detailed history, said Dr. Acosta. Patients identified with more than one phenotype in routine practice at Mayo are often begun on more than one drug. When phenotyping fails to classify a patient, Dr. Acosta puts the patient on a low-calorie diet and then does a follow-up assessment “to see if the phenotype pops up as a metabolic adaptation.”
“This is something we’re all working toward” in the obesity management field. “How can we better identify the underlying causes in a way that can fit into the work flow. How can we move from research to things we can use daily in the clinic,” observed Dr. Clark. “We need a lot more investigation to determine how well this works in the real world. Are there other tools we can use that are not as expensive” as what Dr. Acosta used for this study?
“For this proof of concept study, it made sense to be very rigorous, but that probably is not realistic for every patient. What are other ways to get this information, or perhaps only use an extensive workup when initial weight loss attempts are unsuccessful,” Dr. Clark suggested.
A phenotype-guided strategy for systematically matching weight-loss patients to their potentially ideal weight-loss drug roughly doubled treatment efficacy, compared with usual practice, in a single-center, randomized study with 268 patients.
In contrast, in 200 patients who received weight loss–drug therapy selected by routine means, 35% achieved greater than 10% loss compared with their starting weight, Andres J. Acosta, MD, said at the virtual ObesityWeek® Interactive 2020 meeting.
The phenotype-guided strategy also led to an average 16% weight loss from baseline after 12 months, compared with a 9% average loss among the usual-care controls, reported Dr. Acosta, a gastroenterologist at the Mayo Clinic in Rochester, Minn.
A “one-size-fits-all approach to weight loss treatment is not working,” he declared. “Our long-term goal is to develop a personalized approach to obesity management.”
Personalized weight loss treatment isn’t new
“The better we can match treatment to a patient’s needs, the more likely it will succeed. That’s not a brand new idea. They are trying to standardize the way that we classify the disorders that play a role in why a person gains weight or has trouble losing weight,” commented John D. Clark III, MD, an internal medicine physician and weight-management specialist at UT Southwestern Medical Center in Dallas.
The increased weight loss levels that Dr. Acosta reported in patients who underwent the study’s phenotyping protocol and received tailored treatment “are similar to the numbers we see when a patient’s treatment is the right fit for them. You see weight loss in these ranges,” Dr. Clark said in an interview.
The study run by Dr. Acosta and his associates consisted of two phases. First, they established normal and abnormal ranges for four different obesity phenotypes by studying 100 patients with obesity. The patients underwent an extensive and uniform workup designed to classify their obesity phenotype.
Four obesity phenotypes
The researchers categorized patients into one of four types:
- Disordered initial eating satiation, called ‘hungry brain,” and assessed by measuring food intake at a buffet, ad libidum meal.
- Disordered maintenance of satiety, called “hungry gut,” assessed by both a gastric-emptying study as well as patient self-assessment for postprandial fullness.
- “Emotional hunger,” assessed with two questionnaires.
- Disordered energy expenditure, called “slow burn,” assessed by measuring basal metabolic rate, and self-reports of both exercise and nonexercise activity.
Dr. Acosta estimated that the complete workup to assess all four potential phenotypes costs about $1,200.
The researchers then applied the 75th percentile value from each of these assessments to 450 patients with obesity in their clinic to see the prevalence of the four phenotypes. They identified a single phenotype in 58% of these patients, including 18% with hungry gut, 16% with hungry brain, 12% with emotional hunger, and 12% with slow burn. An additional 27% of the patients were positive for two or more phenotypes (including 9% who were positive for all four phenotypes), and 15% did not test positive for any of the four phenotypes.
Phenotype-guided treatments
They then applied their findings in a prospective randomized study that matched a drug intervention to each of the four phenotypes during a year-long, comprehensive weight-loss program at the Mayo Clinic’s Weight Management Clinic. The study randomized 100 patients to the phenotype-driven arm, with 68 of these patients receiving their assigned drug, and 200 patients served as controls. Patients averaged about 47 years old, and their average body mass index was about 41 kg/m2.
The investigational arm included 30 patients classified as having a hungry brain, with 20 of these patients treated with phentermine plus topiramate and 10 treated with lorcaserin (before it was withdrawn by the Food and Drug Administration); 12 with hungry gut and treated with liraglutide (Saxenda); 19 with emotional hunger who received naltrexone SR/bupropion SR (Contrave); and seven with slow burn who received phentermine.
The control arm included 200 patients seeking weight loss treatment at Mayo who did not undergo phenotyping and received their drug treatment based on their personal preference in consultation with their Mayo physician. In this group, drug treatment broke down as 106 patients (53%) on phentermine plus topiramate, 41 (21%) on liraglutide, 34 (17%) on phentermine alone, 14 (7%) on naltrexone SR/bupropion SR, and 5 patients (3%) on locaserin (percentages total 101% because of rounding).
Overall, phenotyping led to more patients treated with naltrexone SR/buproprion SR and lorcaserin and fewer treated with phentermine or phentermine and topiramate ER. All patients were eligible to also receive behavioral interventions as needed.
“We do a lot of testing to identify the phenotype,” in addition to gathering additional clues from a detailed history, said Dr. Acosta. Patients identified with more than one phenotype in routine practice at Mayo are often begun on more than one drug. When phenotyping fails to classify a patient, Dr. Acosta puts the patient on a low-calorie diet and then does a follow-up assessment “to see if the phenotype pops up as a metabolic adaptation.”
“This is something we’re all working toward” in the obesity management field. “How can we better identify the underlying causes in a way that can fit into the work flow. How can we move from research to things we can use daily in the clinic,” observed Dr. Clark. “We need a lot more investigation to determine how well this works in the real world. Are there other tools we can use that are not as expensive” as what Dr. Acosta used for this study?
“For this proof of concept study, it made sense to be very rigorous, but that probably is not realistic for every patient. What are other ways to get this information, or perhaps only use an extensive workup when initial weight loss attempts are unsuccessful,” Dr. Clark suggested.
A phenotype-guided strategy for systematically matching weight-loss patients to their potentially ideal weight-loss drug roughly doubled treatment efficacy, compared with usual practice, in a single-center, randomized study with 268 patients.
In contrast, in 200 patients who received weight loss–drug therapy selected by routine means, 35% achieved greater than 10% loss compared with their starting weight, Andres J. Acosta, MD, said at the virtual ObesityWeek® Interactive 2020 meeting.
The phenotype-guided strategy also led to an average 16% weight loss from baseline after 12 months, compared with a 9% average loss among the usual-care controls, reported Dr. Acosta, a gastroenterologist at the Mayo Clinic in Rochester, Minn.
A “one-size-fits-all approach to weight loss treatment is not working,” he declared. “Our long-term goal is to develop a personalized approach to obesity management.”
Personalized weight loss treatment isn’t new
“The better we can match treatment to a patient’s needs, the more likely it will succeed. That’s not a brand new idea. They are trying to standardize the way that we classify the disorders that play a role in why a person gains weight or has trouble losing weight,” commented John D. Clark III, MD, an internal medicine physician and weight-management specialist at UT Southwestern Medical Center in Dallas.
The increased weight loss levels that Dr. Acosta reported in patients who underwent the study’s phenotyping protocol and received tailored treatment “are similar to the numbers we see when a patient’s treatment is the right fit for them. You see weight loss in these ranges,” Dr. Clark said in an interview.
The study run by Dr. Acosta and his associates consisted of two phases. First, they established normal and abnormal ranges for four different obesity phenotypes by studying 100 patients with obesity. The patients underwent an extensive and uniform workup designed to classify their obesity phenotype.
Four obesity phenotypes
The researchers categorized patients into one of four types:
- Disordered initial eating satiation, called ‘hungry brain,” and assessed by measuring food intake at a buffet, ad libidum meal.
- Disordered maintenance of satiety, called “hungry gut,” assessed by both a gastric-emptying study as well as patient self-assessment for postprandial fullness.
- “Emotional hunger,” assessed with two questionnaires.
- Disordered energy expenditure, called “slow burn,” assessed by measuring basal metabolic rate, and self-reports of both exercise and nonexercise activity.
Dr. Acosta estimated that the complete workup to assess all four potential phenotypes costs about $1,200.
The researchers then applied the 75th percentile value from each of these assessments to 450 patients with obesity in their clinic to see the prevalence of the four phenotypes. They identified a single phenotype in 58% of these patients, including 18% with hungry gut, 16% with hungry brain, 12% with emotional hunger, and 12% with slow burn. An additional 27% of the patients were positive for two or more phenotypes (including 9% who were positive for all four phenotypes), and 15% did not test positive for any of the four phenotypes.
Phenotype-guided treatments
They then applied their findings in a prospective randomized study that matched a drug intervention to each of the four phenotypes during a year-long, comprehensive weight-loss program at the Mayo Clinic’s Weight Management Clinic. The study randomized 100 patients to the phenotype-driven arm, with 68 of these patients receiving their assigned drug, and 200 patients served as controls. Patients averaged about 47 years old, and their average body mass index was about 41 kg/m2.
The investigational arm included 30 patients classified as having a hungry brain, with 20 of these patients treated with phentermine plus topiramate and 10 treated with lorcaserin (before it was withdrawn by the Food and Drug Administration); 12 with hungry gut and treated with liraglutide (Saxenda); 19 with emotional hunger who received naltrexone SR/bupropion SR (Contrave); and seven with slow burn who received phentermine.
The control arm included 200 patients seeking weight loss treatment at Mayo who did not undergo phenotyping and received their drug treatment based on their personal preference in consultation with their Mayo physician. In this group, drug treatment broke down as 106 patients (53%) on phentermine plus topiramate, 41 (21%) on liraglutide, 34 (17%) on phentermine alone, 14 (7%) on naltrexone SR/bupropion SR, and 5 patients (3%) on locaserin (percentages total 101% because of rounding).
Overall, phenotyping led to more patients treated with naltrexone SR/buproprion SR and lorcaserin and fewer treated with phentermine or phentermine and topiramate ER. All patients were eligible to also receive behavioral interventions as needed.
“We do a lot of testing to identify the phenotype,” in addition to gathering additional clues from a detailed history, said Dr. Acosta. Patients identified with more than one phenotype in routine practice at Mayo are often begun on more than one drug. When phenotyping fails to classify a patient, Dr. Acosta puts the patient on a low-calorie diet and then does a follow-up assessment “to see if the phenotype pops up as a metabolic adaptation.”
“This is something we’re all working toward” in the obesity management field. “How can we better identify the underlying causes in a way that can fit into the work flow. How can we move from research to things we can use daily in the clinic,” observed Dr. Clark. “We need a lot more investigation to determine how well this works in the real world. Are there other tools we can use that are not as expensive” as what Dr. Acosta used for this study?
“For this proof of concept study, it made sense to be very rigorous, but that probably is not realistic for every patient. What are other ways to get this information, or perhaps only use an extensive workup when initial weight loss attempts are unsuccessful,” Dr. Clark suggested.
FROM OBESITY WEEK 2020
Are we shortchanging patients with obesity?
Every Wednesday evening after supper, I record in a marble notebook some anthropomorphic measurements: my weight taken first thing Monday morning and my waist circumference. I also add how I did with exercise since the previous week’s entry and some comments about sleep, energy, and nutrition.
My personal log now comprises dozens of pages. To my surprise, the first entry was 5 years ago to the month. The earlier entries were far from weekly and contained a lot of narrative on how my food-restriction scheme that month was being violated.
Looking just at the numbers, I did about as well as a control group participant in any medical study of diet modification. Until just a few months ago, there was no trend in either weight or waist circumference over those 5 years, including 2 years of retirement. But it wasn’t for lack of trying. Keeping the journal for as long as I have – and recently, as consistently as I have – suggests serious intent but inadequate execution of the same principles I offered patients, who rarely did much better. But recent studies suggest that perhaps quite a few could.
Are we underestimating our patients’ potential?
A recent abstract from the European and International Congress on Obesity suggests that the impressions clinicians get from our office encounters may leave us underestimating the potential for our patients to lose enough weight to move them from one level of risk to another.
Using a national database of primary care visits, the investigators isolated about 550,000 records. Of these, about 60,000 (11%) had records showing weight reductions of 10%-25% (mean, 13%) over at least 4 years. Weight loss was by intent rather than from illness. The remaining individuals maintained their weight within 5% of the first measurement for the duration of the study.
Participants with stable body weight were compared with the successful weight reducers. This analysis showed that the risk for type 2 diabetes, osteoarthritis, sleep apnea, hypertension, and dyslipidemia all measurably declined in weight reducers. This held true whether the patient’s baseline body mass index (BMI) showed modest or severe obesity. Patients with the highest BMI at enrollment actually reduced their risks for hypertension and dyslipidemia below population norms.
This study raises tantalizing, as yet unanswered questions: How did the successful 11% achieve their weight loss goals? Was it via a weight loss program, bariatric surgery, dietitian consult, or with no external assistance?
And of great significance to clinicians: What happened to the people who achieved 5%-10% weight reduction, as that is a more typical outcome of diabetes prevention trials or studies of weight-loss medications? Were they excluded from the study because they did not lose enough weight to achieve the unequivocal health benefit?
Because the data came from an enormous database, the weight management strategies leading to success or failure – what we really need to know to nudge our own patients into the favorable categories – remain hidden.
The Advantage of Intensive Interventions
Some answers emerged from a recently reported study in the New England Journal of Medicine comparing supervised diet and lifestyle adjustments (treatment group) with the less intense oversight typically offered by primary care clinicians (usual-care group).
The treatment group not only received the intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, but also participated in mandated training sessions on how to best use the resources provided by the study. Much of the care was delegated by physicians to “coaches” who focused on nutrition, exercise, and behavioral health, including supermarket strategy.
Nearly a quarter of the participants in the intensive intervention group achieved the 10% weight reduction needed to change health risk in a meaningful way. A similar proportion lost less than 10% of their body weight, and about half did not have a notable weight change. Peak weight loss at 6 months averaged 17 lb, and 9.6 lb at 2 years. While this may not seem very impressive considering the extensive resources utilized, there were those who experienced an extraordinary health upgrade not otherwise available, short of bariatric surgery.
What does this mean for us?
Both studies indicate that, even under the best-controlled, resource-replete circumstances, the rate of failure to achieve desired progress is very high. But there is a success rate.
The likelihood of success is difficult to interpret from the European data, as it compared only those with major weight loss and those with weight stability, excluding patients with less robust loss or weight gain. The controlled study, however, holds forth an alluring opportunity benefiting a quarter of the targeted participants and even about 5% of the controls who realized that they were being observed.
We also learn that supervision requires a lot more than having a well-meaning but not very well-trained physician ask a patient to log measurements and food intake. Health coaches seem to make the impact.
Failure rates of 50% have a way of dampening enthusiasm, but it may be best to approach the scourge of obesity by offering treatment to everyone with the expectation that not all will experience greatly enhanced quality of life and longevity. Not everyone will benefit, but these two studies confirm that we do have an underutilized capacity to help more people benefit than we currently do.
Richard M. Plotzker, MD, is a retired endocrinologist with 40 years of experience treating patients in both the private practice and hospital settings. He has been a Medscape contributor since 2012.
A version of this article originally appeared on Medscape.com.
Every Wednesday evening after supper, I record in a marble notebook some anthropomorphic measurements: my weight taken first thing Monday morning and my waist circumference. I also add how I did with exercise since the previous week’s entry and some comments about sleep, energy, and nutrition.
My personal log now comprises dozens of pages. To my surprise, the first entry was 5 years ago to the month. The earlier entries were far from weekly and contained a lot of narrative on how my food-restriction scheme that month was being violated.
Looking just at the numbers, I did about as well as a control group participant in any medical study of diet modification. Until just a few months ago, there was no trend in either weight or waist circumference over those 5 years, including 2 years of retirement. But it wasn’t for lack of trying. Keeping the journal for as long as I have – and recently, as consistently as I have – suggests serious intent but inadequate execution of the same principles I offered patients, who rarely did much better. But recent studies suggest that perhaps quite a few could.
Are we underestimating our patients’ potential?
A recent abstract from the European and International Congress on Obesity suggests that the impressions clinicians get from our office encounters may leave us underestimating the potential for our patients to lose enough weight to move them from one level of risk to another.
Using a national database of primary care visits, the investigators isolated about 550,000 records. Of these, about 60,000 (11%) had records showing weight reductions of 10%-25% (mean, 13%) over at least 4 years. Weight loss was by intent rather than from illness. The remaining individuals maintained their weight within 5% of the first measurement for the duration of the study.
Participants with stable body weight were compared with the successful weight reducers. This analysis showed that the risk for type 2 diabetes, osteoarthritis, sleep apnea, hypertension, and dyslipidemia all measurably declined in weight reducers. This held true whether the patient’s baseline body mass index (BMI) showed modest or severe obesity. Patients with the highest BMI at enrollment actually reduced their risks for hypertension and dyslipidemia below population norms.
This study raises tantalizing, as yet unanswered questions: How did the successful 11% achieve their weight loss goals? Was it via a weight loss program, bariatric surgery, dietitian consult, or with no external assistance?
And of great significance to clinicians: What happened to the people who achieved 5%-10% weight reduction, as that is a more typical outcome of diabetes prevention trials or studies of weight-loss medications? Were they excluded from the study because they did not lose enough weight to achieve the unequivocal health benefit?
Because the data came from an enormous database, the weight management strategies leading to success or failure – what we really need to know to nudge our own patients into the favorable categories – remain hidden.
The Advantage of Intensive Interventions
Some answers emerged from a recently reported study in the New England Journal of Medicine comparing supervised diet and lifestyle adjustments (treatment group) with the less intense oversight typically offered by primary care clinicians (usual-care group).
The treatment group not only received the intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, but also participated in mandated training sessions on how to best use the resources provided by the study. Much of the care was delegated by physicians to “coaches” who focused on nutrition, exercise, and behavioral health, including supermarket strategy.
Nearly a quarter of the participants in the intensive intervention group achieved the 10% weight reduction needed to change health risk in a meaningful way. A similar proportion lost less than 10% of their body weight, and about half did not have a notable weight change. Peak weight loss at 6 months averaged 17 lb, and 9.6 lb at 2 years. While this may not seem very impressive considering the extensive resources utilized, there were those who experienced an extraordinary health upgrade not otherwise available, short of bariatric surgery.
What does this mean for us?
Both studies indicate that, even under the best-controlled, resource-replete circumstances, the rate of failure to achieve desired progress is very high. But there is a success rate.
The likelihood of success is difficult to interpret from the European data, as it compared only those with major weight loss and those with weight stability, excluding patients with less robust loss or weight gain. The controlled study, however, holds forth an alluring opportunity benefiting a quarter of the targeted participants and even about 5% of the controls who realized that they were being observed.
We also learn that supervision requires a lot more than having a well-meaning but not very well-trained physician ask a patient to log measurements and food intake. Health coaches seem to make the impact.
Failure rates of 50% have a way of dampening enthusiasm, but it may be best to approach the scourge of obesity by offering treatment to everyone with the expectation that not all will experience greatly enhanced quality of life and longevity. Not everyone will benefit, but these two studies confirm that we do have an underutilized capacity to help more people benefit than we currently do.
Richard M. Plotzker, MD, is a retired endocrinologist with 40 years of experience treating patients in both the private practice and hospital settings. He has been a Medscape contributor since 2012.
A version of this article originally appeared on Medscape.com.
Every Wednesday evening after supper, I record in a marble notebook some anthropomorphic measurements: my weight taken first thing Monday morning and my waist circumference. I also add how I did with exercise since the previous week’s entry and some comments about sleep, energy, and nutrition.
My personal log now comprises dozens of pages. To my surprise, the first entry was 5 years ago to the month. The earlier entries were far from weekly and contained a lot of narrative on how my food-restriction scheme that month was being violated.
Looking just at the numbers, I did about as well as a control group participant in any medical study of diet modification. Until just a few months ago, there was no trend in either weight or waist circumference over those 5 years, including 2 years of retirement. But it wasn’t for lack of trying. Keeping the journal for as long as I have – and recently, as consistently as I have – suggests serious intent but inadequate execution of the same principles I offered patients, who rarely did much better. But recent studies suggest that perhaps quite a few could.
Are we underestimating our patients’ potential?
A recent abstract from the European and International Congress on Obesity suggests that the impressions clinicians get from our office encounters may leave us underestimating the potential for our patients to lose enough weight to move them from one level of risk to another.
Using a national database of primary care visits, the investigators isolated about 550,000 records. Of these, about 60,000 (11%) had records showing weight reductions of 10%-25% (mean, 13%) over at least 4 years. Weight loss was by intent rather than from illness. The remaining individuals maintained their weight within 5% of the first measurement for the duration of the study.
Participants with stable body weight were compared with the successful weight reducers. This analysis showed that the risk for type 2 diabetes, osteoarthritis, sleep apnea, hypertension, and dyslipidemia all measurably declined in weight reducers. This held true whether the patient’s baseline body mass index (BMI) showed modest or severe obesity. Patients with the highest BMI at enrollment actually reduced their risks for hypertension and dyslipidemia below population norms.
This study raises tantalizing, as yet unanswered questions: How did the successful 11% achieve their weight loss goals? Was it via a weight loss program, bariatric surgery, dietitian consult, or with no external assistance?
And of great significance to clinicians: What happened to the people who achieved 5%-10% weight reduction, as that is a more typical outcome of diabetes prevention trials or studies of weight-loss medications? Were they excluded from the study because they did not lose enough weight to achieve the unequivocal health benefit?
Because the data came from an enormous database, the weight management strategies leading to success or failure – what we really need to know to nudge our own patients into the favorable categories – remain hidden.
The Advantage of Intensive Interventions
Some answers emerged from a recently reported study in the New England Journal of Medicine comparing supervised diet and lifestyle adjustments (treatment group) with the less intense oversight typically offered by primary care clinicians (usual-care group).
The treatment group not only received the intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, but also participated in mandated training sessions on how to best use the resources provided by the study. Much of the care was delegated by physicians to “coaches” who focused on nutrition, exercise, and behavioral health, including supermarket strategy.
Nearly a quarter of the participants in the intensive intervention group achieved the 10% weight reduction needed to change health risk in a meaningful way. A similar proportion lost less than 10% of their body weight, and about half did not have a notable weight change. Peak weight loss at 6 months averaged 17 lb, and 9.6 lb at 2 years. While this may not seem very impressive considering the extensive resources utilized, there were those who experienced an extraordinary health upgrade not otherwise available, short of bariatric surgery.
What does this mean for us?
Both studies indicate that, even under the best-controlled, resource-replete circumstances, the rate of failure to achieve desired progress is very high. But there is a success rate.
The likelihood of success is difficult to interpret from the European data, as it compared only those with major weight loss and those with weight stability, excluding patients with less robust loss or weight gain. The controlled study, however, holds forth an alluring opportunity benefiting a quarter of the targeted participants and even about 5% of the controls who realized that they were being observed.
We also learn that supervision requires a lot more than having a well-meaning but not very well-trained physician ask a patient to log measurements and food intake. Health coaches seem to make the impact.
Failure rates of 50% have a way of dampening enthusiasm, but it may be best to approach the scourge of obesity by offering treatment to everyone with the expectation that not all will experience greatly enhanced quality of life and longevity. Not everyone will benefit, but these two studies confirm that we do have an underutilized capacity to help more people benefit than we currently do.
Richard M. Plotzker, MD, is a retired endocrinologist with 40 years of experience treating patients in both the private practice and hospital settings. He has been a Medscape contributor since 2012.
A version of this article originally appeared on Medscape.com.
Several strategies can prevent pandemic-related weight gain
If you have been faithfully following the COVID-19 stay-at-home restrictive orders, you may have become a victim of “COVID-15,” the additional, unexpected, unwanted 10- to 15-pound weight gain that is making your clothes not fit so well any more.
A change in routine; being home in comfy, stretchable clothing in front of the TV; and having unhealthy, processed foods ready to grab have set us up to lose the battle with COVID-15. We are set up to gain the weight because of excessive or unhealthful eating, taking an extra daily shot of alcohol, and being inactive, bored, depressed, anxious, and isolated from coworkers and family. Beware – weight gain can be “catching”; we tend to adopt the same poor eating habits and eat the same junk foods as those around us.
Since psychiatry can be a sedentary profession, I’ve (R.W.C.) kept myself very active and physically fit. Prior to the pandemic, I played tennis and ran every day. I was obese only once in my life. I had not realized that I had gained a lot of weight.
Thankfully, a physician called me “obese.” Initially, I was angry at the doctor, however, I realized that he did me the biggest favor of my life. I changed my diet and eating habits, and for the past 20 years, kept my weight between 135-140 pounds and my BMI at 23 consistently – until the pandemic stress caused me to fall into the same bad eating habits that have caused many others to gain the COVID-15.
I was surprised to see that when I weighed myself, and I had gained 12 pounds! I immediately modified my diet and increased my physical activity. I have now lost the extra 12 pounds and will offer suggestions that may help you and your patients exceed your prepandemic physical condition.
Possible solutions
1. Keep a food journal. Write down what you eat, the amount of food you eat, the time you are eating, and your mood at that moment. Keeping a small notebook to record what and when you eat is important because upon review, it will make you face reality and be accountable for what you put in your mouth. Until you review your journal, you may have underestimated the amount, as well as the kinds, of food and drinks you actually consume. A food journal can show your areas of struggle and unhealthy eating habits and help you make necessary changes in your habits and diet to eventually lose weight. You will be less likely to eat junk food or have an extra serving of food. If you do not want to use paper and pencil, you can download an app on your phone, such as myplate tracker to keep track of your food and calorie intake. Do your journaling immediately after you eat and include snacks; do not wait until night time to record your food and journal. Include your mood or how you felt during your meal or snack (for example, were you bored, sad, or anxious) since this information will indicate why you may be overeating.
2. Develop healthful eating habits. Eat a maximum of three meals and three snacks per day but eat only when you are hungry (that is, when your stomach growls or you feel light headed). Limiting yourself to eating only when you are hungry will help eliminate emotional eating to fill a loss in your life or to deal with feelings of stress, anxiety, sadness, or isolation, which have been exacerbated by the pandemic. Buy eat only healthful foods and not items with empty calories, such as chips, cake, and items with sugar. When you are eating, devote yourself to that activity only, eat slowly, and savor each bite. Do not watch television during your meal time.
3. Record the amount and type of exercise you engage in each day and determine the number of calories burned. Walk, run, or bicycle outside, or exercise inside with stretching, weights, or an exercycle. You may use a website, such as diet tool on WebMD.com to calculate daily calories burned. To lose weight, calories burned during a day must exceed caloric intake. You may want to invest in a Fitbit or an Apple Watch and use the health section to determine your caloric intake versus output. Analyzing your caloric data will provide a concrete measure of your progress.
4. Do not overconsume calories or underconsume protein. Protein plays a key role in the creation and maintenance of every cell of your body, and because the body does not store protein, it is important to consume it every day. To meet basic protein requirements, the DRI (Dietary Reference Intake) recommends 0.36 grams of protein per pound (0.8 grams per kg) of body weight. This amounts to: 56 grams per day for the average sedentary man, and 46 grams per day for the average sedentary woman. There is also an app entitled the Protein Tracker that can simplify your calculations.
5. Drink water. It is important to be hydrated to regulate body temperature, keep joints lubricated, prevent infections, deliver nutrients to cells, and keep organs functioning properly. Being well hydrated also improves sleep, cognition, and mood. Your daily water intake by ounce should be equal to your weight in pounds multiplied by two-thirds (or 67%) to determine the amount of water to drink daily. For example, if you weigh 175 pounds, you would multiply 175 by two-thirds and learn that you should be drinking about 117 ounces of water every day. You can also meet some of your daily water requirements by consuming fruits and vegetables, such as tomatoes, watermelon, lettuce, etc.
Also, drink 2 cups (16 oz.) of water before every meal: Often when you feel hungry, it is because your body simply needs water. Science has proven that drinking 2 cups of water before every meal helps you to eat less during meal time and lose weight. If you do this three times daily – at breakfast, lunch, and dinner – you have already consumed 48 ounces of water.
6. Keep track of your progress. In addition to keeping and analyzing your food journal, weigh yourself once or twice a week. Do not weigh yourself every day; you will not see any results on a day-to-day basis, but once a week gives your body time to regulate and show progress. Always calibrate/zero your scale before each use, and weigh yourself at the same time of the day (preferably after you first wake up in the morning) while wearing the same type of clothing. Keep a record of your weight in your journal to track your progress. Do not panic if the scale indicates you gained 1, 2, or 3 pounds, your weight can fluctuate because of glycogen storage, sodium retention, human bias, reporting or recall errors, and home scales can have a plus or minus 3 pound margin of error. Look at your weight trend over time. You may prefer buying a scale that indicates both weight and body mass index.
7. Celebrate and reward yourself with nonfood items. A healthful fitness and diet regime requires energy and dedication, so if you are able to follow a healthful routine, reward yourself with nonfood rewards for your good choices and new habits as an incentive to maintain your healthful behavior.
8. Don’t buy it if you can’t stop eating it. The biggest decision you make is when you decide what you are going to buy. Don’t lie to yourself in the store that you will only eat one at a time. Only buy what you can afford to binge eat if you can’t stop yourself from eating any particular type of food.
9. Have someone hide the food you can’t resist. You can’t eat what you can’t find. If you can’t avoid having irresistible food around, ask another adult to hide the food from you.
10. Learn what harm foods can cause in your body. Read about the effects of high blood sugar and high blood pressure can cause in your body. Find out which foods boost your immune system. Demonize the bad foods in your mind. Make up your mind before you go into the store that you are going to read food labels and find the best quality food with the lowest amount of sugar or saturated fat. Appreciate the flavor of vegetables and fruit.
11. Treat sugar as if it were an addictive drug. You can’t have just one. If you reduce your craving for sugar by slowly reducing your intake of sugar, you will find that you don’t crave sugar any more. This won’t be easy, but once it is done, you will be preventing many of the ravages that sugar takes on your body over time. But you can’t have one piece of pie because the craving will come back. At some point, it may be more likely that you find that piece of pie too sweet.
Here are a few other ideas: Buy a gift for yourself or new clothes, makeup, a plant or flowers, running shoes, exercise clothes, fitness tracker, water bottle, book, movie or network subscription. Improve your home décor. Or treat yourself to online lessons for painting, music, and so on. Or you might adopt a dog, donate food to a shelter or food bank; or organize and declutter your home since staying busy will give you a reason not to eat. In nice weather, enjoy the outdoors by going for a walk, run, bikeride or by gardening.
We are all worried about getting COVID-19. Preventing COVID-15 will go a long way toward boosting our immune systems to help protect us from the coronavirus.
Dr. Cohen is board-certified in psychiatry and has had a private practice in Philadelphia for more than 35 years. His areas of specialty include sports psychiatry, agoraphobia, depression, and substance abuse. In addition, Dr. Cohen is a former professor of psychiatry, family medicine, and otolaryngology at Thomas Jefferson University in Philadelphia. He has no conflicts of interest. Ms. Cohen holds an MBA from Temple University in Philadelphia with a focus on health care administration. Previously, Ms. Cohen was an associate administrator at Hahnemann University Hospital and an executive at the Health Services Council, both in Philadelphia. She currently writes biographical summaries of notable 18th- and 19th-century women. Ms. Cohen has no conflicts of interest.
If you have been faithfully following the COVID-19 stay-at-home restrictive orders, you may have become a victim of “COVID-15,” the additional, unexpected, unwanted 10- to 15-pound weight gain that is making your clothes not fit so well any more.
A change in routine; being home in comfy, stretchable clothing in front of the TV; and having unhealthy, processed foods ready to grab have set us up to lose the battle with COVID-15. We are set up to gain the weight because of excessive or unhealthful eating, taking an extra daily shot of alcohol, and being inactive, bored, depressed, anxious, and isolated from coworkers and family. Beware – weight gain can be “catching”; we tend to adopt the same poor eating habits and eat the same junk foods as those around us.
Since psychiatry can be a sedentary profession, I’ve (R.W.C.) kept myself very active and physically fit. Prior to the pandemic, I played tennis and ran every day. I was obese only once in my life. I had not realized that I had gained a lot of weight.
Thankfully, a physician called me “obese.” Initially, I was angry at the doctor, however, I realized that he did me the biggest favor of my life. I changed my diet and eating habits, and for the past 20 years, kept my weight between 135-140 pounds and my BMI at 23 consistently – until the pandemic stress caused me to fall into the same bad eating habits that have caused many others to gain the COVID-15.
I was surprised to see that when I weighed myself, and I had gained 12 pounds! I immediately modified my diet and increased my physical activity. I have now lost the extra 12 pounds and will offer suggestions that may help you and your patients exceed your prepandemic physical condition.
Possible solutions
1. Keep a food journal. Write down what you eat, the amount of food you eat, the time you are eating, and your mood at that moment. Keeping a small notebook to record what and when you eat is important because upon review, it will make you face reality and be accountable for what you put in your mouth. Until you review your journal, you may have underestimated the amount, as well as the kinds, of food and drinks you actually consume. A food journal can show your areas of struggle and unhealthy eating habits and help you make necessary changes in your habits and diet to eventually lose weight. You will be less likely to eat junk food or have an extra serving of food. If you do not want to use paper and pencil, you can download an app on your phone, such as myplate tracker to keep track of your food and calorie intake. Do your journaling immediately after you eat and include snacks; do not wait until night time to record your food and journal. Include your mood or how you felt during your meal or snack (for example, were you bored, sad, or anxious) since this information will indicate why you may be overeating.
2. Develop healthful eating habits. Eat a maximum of three meals and three snacks per day but eat only when you are hungry (that is, when your stomach growls or you feel light headed). Limiting yourself to eating only when you are hungry will help eliminate emotional eating to fill a loss in your life or to deal with feelings of stress, anxiety, sadness, or isolation, which have been exacerbated by the pandemic. Buy eat only healthful foods and not items with empty calories, such as chips, cake, and items with sugar. When you are eating, devote yourself to that activity only, eat slowly, and savor each bite. Do not watch television during your meal time.
3. Record the amount and type of exercise you engage in each day and determine the number of calories burned. Walk, run, or bicycle outside, or exercise inside with stretching, weights, or an exercycle. You may use a website, such as diet tool on WebMD.com to calculate daily calories burned. To lose weight, calories burned during a day must exceed caloric intake. You may want to invest in a Fitbit or an Apple Watch and use the health section to determine your caloric intake versus output. Analyzing your caloric data will provide a concrete measure of your progress.
4. Do not overconsume calories or underconsume protein. Protein plays a key role in the creation and maintenance of every cell of your body, and because the body does not store protein, it is important to consume it every day. To meet basic protein requirements, the DRI (Dietary Reference Intake) recommends 0.36 grams of protein per pound (0.8 grams per kg) of body weight. This amounts to: 56 grams per day for the average sedentary man, and 46 grams per day for the average sedentary woman. There is also an app entitled the Protein Tracker that can simplify your calculations.
5. Drink water. It is important to be hydrated to regulate body temperature, keep joints lubricated, prevent infections, deliver nutrients to cells, and keep organs functioning properly. Being well hydrated also improves sleep, cognition, and mood. Your daily water intake by ounce should be equal to your weight in pounds multiplied by two-thirds (or 67%) to determine the amount of water to drink daily. For example, if you weigh 175 pounds, you would multiply 175 by two-thirds and learn that you should be drinking about 117 ounces of water every day. You can also meet some of your daily water requirements by consuming fruits and vegetables, such as tomatoes, watermelon, lettuce, etc.
Also, drink 2 cups (16 oz.) of water before every meal: Often when you feel hungry, it is because your body simply needs water. Science has proven that drinking 2 cups of water before every meal helps you to eat less during meal time and lose weight. If you do this three times daily – at breakfast, lunch, and dinner – you have already consumed 48 ounces of water.
6. Keep track of your progress. In addition to keeping and analyzing your food journal, weigh yourself once or twice a week. Do not weigh yourself every day; you will not see any results on a day-to-day basis, but once a week gives your body time to regulate and show progress. Always calibrate/zero your scale before each use, and weigh yourself at the same time of the day (preferably after you first wake up in the morning) while wearing the same type of clothing. Keep a record of your weight in your journal to track your progress. Do not panic if the scale indicates you gained 1, 2, or 3 pounds, your weight can fluctuate because of glycogen storage, sodium retention, human bias, reporting or recall errors, and home scales can have a plus or minus 3 pound margin of error. Look at your weight trend over time. You may prefer buying a scale that indicates both weight and body mass index.
7. Celebrate and reward yourself with nonfood items. A healthful fitness and diet regime requires energy and dedication, so if you are able to follow a healthful routine, reward yourself with nonfood rewards for your good choices and new habits as an incentive to maintain your healthful behavior.
8. Don’t buy it if you can’t stop eating it. The biggest decision you make is when you decide what you are going to buy. Don’t lie to yourself in the store that you will only eat one at a time. Only buy what you can afford to binge eat if you can’t stop yourself from eating any particular type of food.
9. Have someone hide the food you can’t resist. You can’t eat what you can’t find. If you can’t avoid having irresistible food around, ask another adult to hide the food from you.
10. Learn what harm foods can cause in your body. Read about the effects of high blood sugar and high blood pressure can cause in your body. Find out which foods boost your immune system. Demonize the bad foods in your mind. Make up your mind before you go into the store that you are going to read food labels and find the best quality food with the lowest amount of sugar or saturated fat. Appreciate the flavor of vegetables and fruit.
11. Treat sugar as if it were an addictive drug. You can’t have just one. If you reduce your craving for sugar by slowly reducing your intake of sugar, you will find that you don’t crave sugar any more. This won’t be easy, but once it is done, you will be preventing many of the ravages that sugar takes on your body over time. But you can’t have one piece of pie because the craving will come back. At some point, it may be more likely that you find that piece of pie too sweet.
Here are a few other ideas: Buy a gift for yourself or new clothes, makeup, a plant or flowers, running shoes, exercise clothes, fitness tracker, water bottle, book, movie or network subscription. Improve your home décor. Or treat yourself to online lessons for painting, music, and so on. Or you might adopt a dog, donate food to a shelter or food bank; or organize and declutter your home since staying busy will give you a reason not to eat. In nice weather, enjoy the outdoors by going for a walk, run, bikeride or by gardening.
We are all worried about getting COVID-19. Preventing COVID-15 will go a long way toward boosting our immune systems to help protect us from the coronavirus.
Dr. Cohen is board-certified in psychiatry and has had a private practice in Philadelphia for more than 35 years. His areas of specialty include sports psychiatry, agoraphobia, depression, and substance abuse. In addition, Dr. Cohen is a former professor of psychiatry, family medicine, and otolaryngology at Thomas Jefferson University in Philadelphia. He has no conflicts of interest. Ms. Cohen holds an MBA from Temple University in Philadelphia with a focus on health care administration. Previously, Ms. Cohen was an associate administrator at Hahnemann University Hospital and an executive at the Health Services Council, both in Philadelphia. She currently writes biographical summaries of notable 18th- and 19th-century women. Ms. Cohen has no conflicts of interest.
If you have been faithfully following the COVID-19 stay-at-home restrictive orders, you may have become a victim of “COVID-15,” the additional, unexpected, unwanted 10- to 15-pound weight gain that is making your clothes not fit so well any more.
A change in routine; being home in comfy, stretchable clothing in front of the TV; and having unhealthy, processed foods ready to grab have set us up to lose the battle with COVID-15. We are set up to gain the weight because of excessive or unhealthful eating, taking an extra daily shot of alcohol, and being inactive, bored, depressed, anxious, and isolated from coworkers and family. Beware – weight gain can be “catching”; we tend to adopt the same poor eating habits and eat the same junk foods as those around us.
Since psychiatry can be a sedentary profession, I’ve (R.W.C.) kept myself very active and physically fit. Prior to the pandemic, I played tennis and ran every day. I was obese only once in my life. I had not realized that I had gained a lot of weight.
Thankfully, a physician called me “obese.” Initially, I was angry at the doctor, however, I realized that he did me the biggest favor of my life. I changed my diet and eating habits, and for the past 20 years, kept my weight between 135-140 pounds and my BMI at 23 consistently – until the pandemic stress caused me to fall into the same bad eating habits that have caused many others to gain the COVID-15.
I was surprised to see that when I weighed myself, and I had gained 12 pounds! I immediately modified my diet and increased my physical activity. I have now lost the extra 12 pounds and will offer suggestions that may help you and your patients exceed your prepandemic physical condition.
Possible solutions
1. Keep a food journal. Write down what you eat, the amount of food you eat, the time you are eating, and your mood at that moment. Keeping a small notebook to record what and when you eat is important because upon review, it will make you face reality and be accountable for what you put in your mouth. Until you review your journal, you may have underestimated the amount, as well as the kinds, of food and drinks you actually consume. A food journal can show your areas of struggle and unhealthy eating habits and help you make necessary changes in your habits and diet to eventually lose weight. You will be less likely to eat junk food or have an extra serving of food. If you do not want to use paper and pencil, you can download an app on your phone, such as myplate tracker to keep track of your food and calorie intake. Do your journaling immediately after you eat and include snacks; do not wait until night time to record your food and journal. Include your mood or how you felt during your meal or snack (for example, were you bored, sad, or anxious) since this information will indicate why you may be overeating.
2. Develop healthful eating habits. Eat a maximum of three meals and three snacks per day but eat only when you are hungry (that is, when your stomach growls or you feel light headed). Limiting yourself to eating only when you are hungry will help eliminate emotional eating to fill a loss in your life or to deal with feelings of stress, anxiety, sadness, or isolation, which have been exacerbated by the pandemic. Buy eat only healthful foods and not items with empty calories, such as chips, cake, and items with sugar. When you are eating, devote yourself to that activity only, eat slowly, and savor each bite. Do not watch television during your meal time.
3. Record the amount and type of exercise you engage in each day and determine the number of calories burned. Walk, run, or bicycle outside, or exercise inside with stretching, weights, or an exercycle. You may use a website, such as diet tool on WebMD.com to calculate daily calories burned. To lose weight, calories burned during a day must exceed caloric intake. You may want to invest in a Fitbit or an Apple Watch and use the health section to determine your caloric intake versus output. Analyzing your caloric data will provide a concrete measure of your progress.
4. Do not overconsume calories or underconsume protein. Protein plays a key role in the creation and maintenance of every cell of your body, and because the body does not store protein, it is important to consume it every day. To meet basic protein requirements, the DRI (Dietary Reference Intake) recommends 0.36 grams of protein per pound (0.8 grams per kg) of body weight. This amounts to: 56 grams per day for the average sedentary man, and 46 grams per day for the average sedentary woman. There is also an app entitled the Protein Tracker that can simplify your calculations.
5. Drink water. It is important to be hydrated to regulate body temperature, keep joints lubricated, prevent infections, deliver nutrients to cells, and keep organs functioning properly. Being well hydrated also improves sleep, cognition, and mood. Your daily water intake by ounce should be equal to your weight in pounds multiplied by two-thirds (or 67%) to determine the amount of water to drink daily. For example, if you weigh 175 pounds, you would multiply 175 by two-thirds and learn that you should be drinking about 117 ounces of water every day. You can also meet some of your daily water requirements by consuming fruits and vegetables, such as tomatoes, watermelon, lettuce, etc.
Also, drink 2 cups (16 oz.) of water before every meal: Often when you feel hungry, it is because your body simply needs water. Science has proven that drinking 2 cups of water before every meal helps you to eat less during meal time and lose weight. If you do this three times daily – at breakfast, lunch, and dinner – you have already consumed 48 ounces of water.
6. Keep track of your progress. In addition to keeping and analyzing your food journal, weigh yourself once or twice a week. Do not weigh yourself every day; you will not see any results on a day-to-day basis, but once a week gives your body time to regulate and show progress. Always calibrate/zero your scale before each use, and weigh yourself at the same time of the day (preferably after you first wake up in the morning) while wearing the same type of clothing. Keep a record of your weight in your journal to track your progress. Do not panic if the scale indicates you gained 1, 2, or 3 pounds, your weight can fluctuate because of glycogen storage, sodium retention, human bias, reporting or recall errors, and home scales can have a plus or minus 3 pound margin of error. Look at your weight trend over time. You may prefer buying a scale that indicates both weight and body mass index.
7. Celebrate and reward yourself with nonfood items. A healthful fitness and diet regime requires energy and dedication, so if you are able to follow a healthful routine, reward yourself with nonfood rewards for your good choices and new habits as an incentive to maintain your healthful behavior.
8. Don’t buy it if you can’t stop eating it. The biggest decision you make is when you decide what you are going to buy. Don’t lie to yourself in the store that you will only eat one at a time. Only buy what you can afford to binge eat if you can’t stop yourself from eating any particular type of food.
9. Have someone hide the food you can’t resist. You can’t eat what you can’t find. If you can’t avoid having irresistible food around, ask another adult to hide the food from you.
10. Learn what harm foods can cause in your body. Read about the effects of high blood sugar and high blood pressure can cause in your body. Find out which foods boost your immune system. Demonize the bad foods in your mind. Make up your mind before you go into the store that you are going to read food labels and find the best quality food with the lowest amount of sugar or saturated fat. Appreciate the flavor of vegetables and fruit.
11. Treat sugar as if it were an addictive drug. You can’t have just one. If you reduce your craving for sugar by slowly reducing your intake of sugar, you will find that you don’t crave sugar any more. This won’t be easy, but once it is done, you will be preventing many of the ravages that sugar takes on your body over time. But you can’t have one piece of pie because the craving will come back. At some point, it may be more likely that you find that piece of pie too sweet.
Here are a few other ideas: Buy a gift for yourself or new clothes, makeup, a plant or flowers, running shoes, exercise clothes, fitness tracker, water bottle, book, movie or network subscription. Improve your home décor. Or treat yourself to online lessons for painting, music, and so on. Or you might adopt a dog, donate food to a shelter or food bank; or organize and declutter your home since staying busy will give you a reason not to eat. In nice weather, enjoy the outdoors by going for a walk, run, bikeride or by gardening.
We are all worried about getting COVID-19. Preventing COVID-15 will go a long way toward boosting our immune systems to help protect us from the coronavirus.
Dr. Cohen is board-certified in psychiatry and has had a private practice in Philadelphia for more than 35 years. His areas of specialty include sports psychiatry, agoraphobia, depression, and substance abuse. In addition, Dr. Cohen is a former professor of psychiatry, family medicine, and otolaryngology at Thomas Jefferson University in Philadelphia. He has no conflicts of interest. Ms. Cohen holds an MBA from Temple University in Philadelphia with a focus on health care administration. Previously, Ms. Cohen was an associate administrator at Hahnemann University Hospital and an executive at the Health Services Council, both in Philadelphia. She currently writes biographical summaries of notable 18th- and 19th-century women. Ms. Cohen has no conflicts of interest.