Diabetes

ASUNCIÓN, PARAGUAY — Sarcopenic obesity, which is characterized by excess adiposity and muscle loss, is an “underestimated and underdiagnosed” condition, said the panelists at a session of the XV Latin American Obesity Congress (FLASO 2024) and II Paraguayan Congress of Obesity. The condition often affects older adults but can also occur at any age as a result of unhealthy habits or intensive or repeated weight loss efforts. 

“The drugs currently used for managing obesity promote significant weight loss, but by losing fat, muscle is also lost,” said Fabiola Romero Gómez, MD, a professor of medicine at the National University of Asunción and president of the Paraguayan Society of Endocrinology and Metabolism. “We must handle [these drugs] with extreme care. When we employ a strategy that achieves this significant weight loss, we must ensure that the patient receives a good protein intake and engages in resistance exercises, because otherwise, the cure may be worse than the disease.”

Some patients develop sarcopenic obesity after using glucagon-like peptide-1 (GLP-1) analogs, undergoing bariatric surgery, or pursuing restrictive diets, Dr. Romero said in an interview. The condition is more common when there are long-standing cycles of weight loss and subsequent gain, “which accounts for the majority of our patients,” she said.

“An important, largely ignored aspect of weight loss, whether through pharmacological or lifestyle intervention, is that a portion of the weight loss comprises lean muscle,” according to a recent editorial in Nature Medicine. “Weight regain, however, is almost entirely fat. People with chronic obesity often lose and regain weight in repeated cycles, each of which results in body-composition changes (even if they experience some net weight loss). This cycling puts people unable to sustain weight loss at risk of being metabolically less healthy than they were before the initial weight loss was achieved — in effect, at risk of developing sarcopenic obesity.”
 

A ‘Hidden’ Problem

Sarcopenic obesity is “something hidden, something that we often do not see. Why? Because if we do not make measurements of body composition, we will not realize it,” said Dr. Romero.

According to the 2022 consensus of the European Society for Clinical Nutrition and Metabolism and the European Association for the Study of Obesity, clinical signs or factors suggesting sarcopenic obesity include age over 70 years, diagnosis of a chronic disease, repeated falls or weakness, and nutritional events such as recent weight loss or rapid gain, long-standing restrictive diets, and bariatric surgery. 

The European guidelines also propose screening in individuals at risk to check for an increased body mass index (BMI) or waist circumference and suspicion parameters of sarcopenia. In this group of patients, the diagnosis should be made based on the analysis of alterations in muscle-skeletal functional parameters, such as grip or pinch strength or the 30-second chair stand test, followed by a determination of body mass alteration using dual-energy x-ray absorptiometry or electrical bioimpedance. 

Electrical bioimpedance is Dr. Romero’s preferred method. It is an economical, simple, and easily transportable test that calculates lean muscle mass, fat mass, and body water based on electrical conductivity, she said. Experts have pointed out that bioimpedance scales “will revolutionize the way we measure obesity,” she added. 

In an as-yet-unpublished study that received an honorable mention at the 3rd Paraguayan Congress of Endocrinology, Diabetes, and Metabolism last year, Dr. Romero and colleagues studied 126 patients (median age, 45 years) with obesity defined by percentage of fat mass determined by bioimpedance. When their BMI was analyzed, 11.1% were “normal” weight, and 35.7% were “overweight.” Even waist circumference measurement suggested that about 15% of participants were without obesity. Moreover, almost one in four participants presented with sarcopenia, “implying a decrease in quality of life and physical disability in the future if not investigated, diagnosed, and treated correctly,” said Dr. Romero. 
 

Prevention and Recommendations

Exercise and nutrition are two key components in the prevention and management of sarcopenic obesity. Physicians prescribing GLP-1 receptor agonists “must also counsel patients about incorporating aerobic exercise and resistance training as part of the treatment plan, as well as ensuring they eat a high-protein diet,” Yoon Ji Ahn, MD, and Vibha Singhal, MD, MPH, of the Weight Management Center of Massachusetts General Hospital in Boston, wrote in a commentary published by this news organization.

Paraguayan nutritionist Patricia López Soto, a diabetes educator with postgraduate degrees in obesity, diabetes, and bariatric surgery from Favaloro University in Buenos Aires, shared with this news organization the following general recommendations to prevent sarcopenic obesity in patients undergoing weight loss treatment: 

• Follow a healthy and balanced Mediterranean or DASH-style diet.
• Increase protein intake at the three to four main meals to a minimum of 1.4-1.5 g/kg/day.
• Try to make the protein intake mostly of high biological value: Beef, chicken, fish, eggs, seafood, cheese, skim milk, and yogurt.
• Ensure protein intake at each meal of between 25 g and 30 g to increase protein synthesis. For example, a 150 g portion of meat or chicken provides 30 g of protein.
• If the protein intake is not achieved through food, a supplement measure like isolated and hydrolyzed whey protein is a good option.
• Engage in strength or resistance training (weightlifting) three to four times per week and 30 minutes of cardiovascular exercise every day.
• To improve adherence, treatment should be carried out with a multidisciplinary team that includes a physician, nutritionist, and physical trainer, with frequent check-ups and body composition studies by bioimpedance.

Dr. Romero and Ms. López declared no relevant financial relationships. 
 

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

ASUNCIÓN, PARAGUAY — Sarcopenic obesity, which is characterized by excess adiposity and muscle loss, is an “underestimated and underdiagnosed” condition, said the panelists at a session of the XV Latin American Obesity Congress (FLASO 2024) and II Paraguayan Congress of Obesity. The condition often affects older adults but can also occur at any age as a result of unhealthy habits or intensive or repeated weight loss efforts. 

“The drugs currently used for managing obesity promote significant weight loss, but by losing fat, muscle is also lost,” said Fabiola Romero Gómez, MD, a professor of medicine at the National University of Asunción and president of the Paraguayan Society of Endocrinology and Metabolism. “We must handle [these drugs] with extreme care. When we employ a strategy that achieves this significant weight loss, we must ensure that the patient receives a good protein intake and engages in resistance exercises, because otherwise, the cure may be worse than the disease.”

Some patients develop sarcopenic obesity after using glucagon-like peptide-1 (GLP-1) analogs, undergoing bariatric surgery, or pursuing restrictive diets, Dr. Romero said in an interview. The condition is more common when there are long-standing cycles of weight loss and subsequent gain, “which accounts for the majority of our patients,” she said.

“An important, largely ignored aspect of weight loss, whether through pharmacological or lifestyle intervention, is that a portion of the weight loss comprises lean muscle,” according to a recent editorial in Nature Medicine. “Weight regain, however, is almost entirely fat. People with chronic obesity often lose and regain weight in repeated cycles, each of which results in body-composition changes (even if they experience some net weight loss). This cycling puts people unable to sustain weight loss at risk of being metabolically less healthy than they were before the initial weight loss was achieved — in effect, at risk of developing sarcopenic obesity.”
 

A ‘Hidden’ Problem

Sarcopenic obesity is “something hidden, something that we often do not see. Why? Because if we do not make measurements of body composition, we will not realize it,” said Dr. Romero.

According to the 2022 consensus of the European Society for Clinical Nutrition and Metabolism and the European Association for the Study of Obesity, clinical signs or factors suggesting sarcopenic obesity include age over 70 years, diagnosis of a chronic disease, repeated falls or weakness, and nutritional events such as recent weight loss or rapid gain, long-standing restrictive diets, and bariatric surgery. 

The European guidelines also propose screening in individuals at risk to check for an increased body mass index (BMI) or waist circumference and suspicion parameters of sarcopenia. In this group of patients, the diagnosis should be made based on the analysis of alterations in muscle-skeletal functional parameters, such as grip or pinch strength or the 30-second chair stand test, followed by a determination of body mass alteration using dual-energy x-ray absorptiometry or electrical bioimpedance. 

Electrical bioimpedance is Dr. Romero’s preferred method. It is an economical, simple, and easily transportable test that calculates lean muscle mass, fat mass, and body water based on electrical conductivity, she said. Experts have pointed out that bioimpedance scales “will revolutionize the way we measure obesity,” she added. 

In an as-yet-unpublished study that received an honorable mention at the 3rd Paraguayan Congress of Endocrinology, Diabetes, and Metabolism last year, Dr. Romero and colleagues studied 126 patients (median age, 45 years) with obesity defined by percentage of fat mass determined by bioimpedance. When their BMI was analyzed, 11.1% were “normal” weight, and 35.7% were “overweight.” Even waist circumference measurement suggested that about 15% of participants were without obesity. Moreover, almost one in four participants presented with sarcopenia, “implying a decrease in quality of life and physical disability in the future if not investigated, diagnosed, and treated correctly,” said Dr. Romero. 
 

Prevention and Recommendations

Exercise and nutrition are two key components in the prevention and management of sarcopenic obesity. Physicians prescribing GLP-1 receptor agonists “must also counsel patients about incorporating aerobic exercise and resistance training as part of the treatment plan, as well as ensuring they eat a high-protein diet,” Yoon Ji Ahn, MD, and Vibha Singhal, MD, MPH, of the Weight Management Center of Massachusetts General Hospital in Boston, wrote in a commentary published by this news organization.

Paraguayan nutritionist Patricia López Soto, a diabetes educator with postgraduate degrees in obesity, diabetes, and bariatric surgery from Favaloro University in Buenos Aires, shared with this news organization the following general recommendations to prevent sarcopenic obesity in patients undergoing weight loss treatment: 

• Follow a healthy and balanced Mediterranean or DASH-style diet.
• Increase protein intake at the three to four main meals to a minimum of 1.4-1.5 g/kg/day.
• Try to make the protein intake mostly of high biological value: Beef, chicken, fish, eggs, seafood, cheese, skim milk, and yogurt.
• Ensure protein intake at each meal of between 25 g and 30 g to increase protein synthesis. For example, a 150 g portion of meat or chicken provides 30 g of protein.
• If the protein intake is not achieved through food, a supplement measure like isolated and hydrolyzed whey protein is a good option.
• Engage in strength or resistance training (weightlifting) three to four times per week and 30 minutes of cardiovascular exercise every day.
• To improve adherence, treatment should be carried out with a multidisciplinary team that includes a physician, nutritionist, and physical trainer, with frequent check-ups and body composition studies by bioimpedance.

Dr. Romero and Ms. López declared no relevant financial relationships. 
 

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

ASUNCIÓN, PARAGUAY — Sarcopenic obesity, which is characterized by excess adiposity and muscle loss, is an “underestimated and underdiagnosed” condition, said the panelists at a session of the XV Latin American Obesity Congress (FLASO 2024) and II Paraguayan Congress of Obesity. The condition often affects older adults but can also occur at any age as a result of unhealthy habits or intensive or repeated weight loss efforts. 

“The drugs currently used for managing obesity promote significant weight loss, but by losing fat, muscle is also lost,” said Fabiola Romero Gómez, MD, a professor of medicine at the National University of Asunción and president of the Paraguayan Society of Endocrinology and Metabolism. “We must handle [these drugs] with extreme care. When we employ a strategy that achieves this significant weight loss, we must ensure that the patient receives a good protein intake and engages in resistance exercises, because otherwise, the cure may be worse than the disease.”

Some patients develop sarcopenic obesity after using glucagon-like peptide-1 (GLP-1) analogs, undergoing bariatric surgery, or pursuing restrictive diets, Dr. Romero said in an interview. The condition is more common when there are long-standing cycles of weight loss and subsequent gain, “which accounts for the majority of our patients,” she said.

“An important, largely ignored aspect of weight loss, whether through pharmacological or lifestyle intervention, is that a portion of the weight loss comprises lean muscle,” according to a recent editorial in Nature Medicine. “Weight regain, however, is almost entirely fat. People with chronic obesity often lose and regain weight in repeated cycles, each of which results in body-composition changes (even if they experience some net weight loss). This cycling puts people unable to sustain weight loss at risk of being metabolically less healthy than they were before the initial weight loss was achieved — in effect, at risk of developing sarcopenic obesity.”
 

A ‘Hidden’ Problem

Sarcopenic obesity is “something hidden, something that we often do not see. Why? Because if we do not make measurements of body composition, we will not realize it,” said Dr. Romero.

According to the 2022 consensus of the European Society for Clinical Nutrition and Metabolism and the European Association for the Study of Obesity, clinical signs or factors suggesting sarcopenic obesity include age over 70 years, diagnosis of a chronic disease, repeated falls or weakness, and nutritional events such as recent weight loss or rapid gain, long-standing restrictive diets, and bariatric surgery. 

The European guidelines also propose screening in individuals at risk to check for an increased body mass index (BMI) or waist circumference and suspicion parameters of sarcopenia. In this group of patients, the diagnosis should be made based on the analysis of alterations in muscle-skeletal functional parameters, such as grip or pinch strength or the 30-second chair stand test, followed by a determination of body mass alteration using dual-energy x-ray absorptiometry or electrical bioimpedance. 

Electrical bioimpedance is Dr. Romero’s preferred method. It is an economical, simple, and easily transportable test that calculates lean muscle mass, fat mass, and body water based on electrical conductivity, she said. Experts have pointed out that bioimpedance scales “will revolutionize the way we measure obesity,” she added. 

In an as-yet-unpublished study that received an honorable mention at the 3rd Paraguayan Congress of Endocrinology, Diabetes, and Metabolism last year, Dr. Romero and colleagues studied 126 patients (median age, 45 years) with obesity defined by percentage of fat mass determined by bioimpedance. When their BMI was analyzed, 11.1% were “normal” weight, and 35.7% were “overweight.” Even waist circumference measurement suggested that about 15% of participants were without obesity. Moreover, almost one in four participants presented with sarcopenia, “implying a decrease in quality of life and physical disability in the future if not investigated, diagnosed, and treated correctly,” said Dr. Romero. 
 

Prevention and Recommendations

Exercise and nutrition are two key components in the prevention and management of sarcopenic obesity. Physicians prescribing GLP-1 receptor agonists “must also counsel patients about incorporating aerobic exercise and resistance training as part of the treatment plan, as well as ensuring they eat a high-protein diet,” Yoon Ji Ahn, MD, and Vibha Singhal, MD, MPH, of the Weight Management Center of Massachusetts General Hospital in Boston, wrote in a commentary published by this news organization.

Paraguayan nutritionist Patricia López Soto, a diabetes educator with postgraduate degrees in obesity, diabetes, and bariatric surgery from Favaloro University in Buenos Aires, shared with this news organization the following general recommendations to prevent sarcopenic obesity in patients undergoing weight loss treatment: 

• Follow a healthy and balanced Mediterranean or DASH-style diet.
• Increase protein intake at the three to four main meals to a minimum of 1.4-1.5 g/kg/day.
• Try to make the protein intake mostly of high biological value: Beef, chicken, fish, eggs, seafood, cheese, skim milk, and yogurt.
• Ensure protein intake at each meal of between 25 g and 30 g to increase protein synthesis. For example, a 150 g portion of meat or chicken provides 30 g of protein.
• If the protein intake is not achieved through food, a supplement measure like isolated and hydrolyzed whey protein is a good option.
• Engage in strength or resistance training (weightlifting) three to four times per week and 30 minutes of cardiovascular exercise every day.
• To improve adherence, treatment should be carried out with a multidisciplinary team that includes a physician, nutritionist, and physical trainer, with frequent check-ups and body composition studies by bioimpedance.

Dr. Romero and Ms. López declared no relevant financial relationships. 
 

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Excessive intrapancreatic fat deposition (IPFD) leading to fatty change of the pancreas (FP) was prevalent in almost 18% of participants in a large population-based cohort, and both IPFD and FP were associated with an increased risk for diabetes, acute pancreatitis, and pancreatic cancer.

METHODOLOGY:

• Excessive IPFD is a common pancreatic disorder in the general population; however, there is a paucity of longitudinal studies investigating the relationship between FP and the risk for exocrine and endocrine pancreatic diseases.
• This prospective cohort study conducted from July 2014 to January 2023 investigated the prevalence of FP and the link between IPFD and pancreatic diseases in 42,599 participants (median age, 65 years; 46.6% men) from the UK Biobank who underwent abdominal Dixon MRI.
• IPFD levels were measured using MRI and a deep learning-based framework called nnUNet.
• The outcomes assessed in this study were diseases of the exocrine pancreas and endocrine pancreas, including acute pancreatitis, pancreatic cancer, diabetes, and other pancreatic conditions.

TAKEAWAY:

• The prevalence of FP was 17.86%.
• Elevation in IPFD levels by one quintile increased the risk for the development of acute pancreatitis by 51.3% (P = .001), pancreatic cancer by 36.5% (P = .017), diabetes by 22.1% (P < .001), and all pancreatic diseases by 22.7% (P < .001).
• FP increased the risk for acute pancreatitis by 298.2% (P < .001), pancreatic cancer by 97.6% (P = .034), diabetes by 33.7% (P = .001), and all pancreatic diseases by 44.1% (P < .001).
• An increasing trend in the prevalence of FP with advancing age was observed in both men and women.

IN PRACTICE:

“FP is a common pancreatic disorder. Fat in the pancreas is an independent risk factor for diseases of both the exocrine pancreas and endocrine pancreas,” the authors wrote.

SOURCE:

This study, led by Xiaowu Dong, MD, of the Pancreatic Center, Department of Gastroenterology, Yangzhou Key Laboratory of Pancreatic Disease, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

The authors acknowledged that most of the enrolled participants were White and older than 45 years. A low response rate to recruitment invitations in the UK Biobank database may have introduced self-selection bias. The median follow-up duration of 4.61 years was short and may be insufficient to fully capture the impact of IPFD. Additionally, the use of the average fat fraction for the entire pancreas may have led to spatial variations being ignored.

DISCLOSURES:

This work was supported by the National Natural Science Foundation of China, Cultivation Foundation of Yangzhou Municipal Key Laboratory, The Medical Research Project of Jiangsu Provincial Health Commission, Yangzhou key research and development plan, and Suzhou Innovation Platform Construction Projects-Municipal Key Laboratory Construction. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Excessive intrapancreatic fat deposition (IPFD) leading to fatty change of the pancreas (FP) was prevalent in almost 18% of participants in a large population-based cohort, and both IPFD and FP were associated with an increased risk for diabetes, acute pancreatitis, and pancreatic cancer.

METHODOLOGY:

• Excessive IPFD is a common pancreatic disorder in the general population; however, there is a paucity of longitudinal studies investigating the relationship between FP and the risk for exocrine and endocrine pancreatic diseases.
• This prospective cohort study conducted from July 2014 to January 2023 investigated the prevalence of FP and the link between IPFD and pancreatic diseases in 42,599 participants (median age, 65 years; 46.6% men) from the UK Biobank who underwent abdominal Dixon MRI.
• IPFD levels were measured using MRI and a deep learning-based framework called nnUNet.
• The outcomes assessed in this study were diseases of the exocrine pancreas and endocrine pancreas, including acute pancreatitis, pancreatic cancer, diabetes, and other pancreatic conditions.

TAKEAWAY:

• The prevalence of FP was 17.86%.
• Elevation in IPFD levels by one quintile increased the risk for the development of acute pancreatitis by 51.3% (P = .001), pancreatic cancer by 36.5% (P = .017), diabetes by 22.1% (P < .001), and all pancreatic diseases by 22.7% (P < .001).
• FP increased the risk for acute pancreatitis by 298.2% (P < .001), pancreatic cancer by 97.6% (P = .034), diabetes by 33.7% (P = .001), and all pancreatic diseases by 44.1% (P < .001).
• An increasing trend in the prevalence of FP with advancing age was observed in both men and women.

IN PRACTICE:

“FP is a common pancreatic disorder. Fat in the pancreas is an independent risk factor for diseases of both the exocrine pancreas and endocrine pancreas,” the authors wrote.

SOURCE:

This study, led by Xiaowu Dong, MD, of the Pancreatic Center, Department of Gastroenterology, Yangzhou Key Laboratory of Pancreatic Disease, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

The authors acknowledged that most of the enrolled participants were White and older than 45 years. A low response rate to recruitment invitations in the UK Biobank database may have introduced self-selection bias. The median follow-up duration of 4.61 years was short and may be insufficient to fully capture the impact of IPFD. Additionally, the use of the average fat fraction for the entire pancreas may have led to spatial variations being ignored.

DISCLOSURES:

This work was supported by the National Natural Science Foundation of China, Cultivation Foundation of Yangzhou Municipal Key Laboratory, The Medical Research Project of Jiangsu Provincial Health Commission, Yangzhou key research and development plan, and Suzhou Innovation Platform Construction Projects-Municipal Key Laboratory Construction. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Excessive intrapancreatic fat deposition (IPFD) leading to fatty change of the pancreas (FP) was prevalent in almost 18% of participants in a large population-based cohort, and both IPFD and FP were associated with an increased risk for diabetes, acute pancreatitis, and pancreatic cancer.

METHODOLOGY:

• Excessive IPFD is a common pancreatic disorder in the general population; however, there is a paucity of longitudinal studies investigating the relationship between FP and the risk for exocrine and endocrine pancreatic diseases.
• This prospective cohort study conducted from July 2014 to January 2023 investigated the prevalence of FP and the link between IPFD and pancreatic diseases in 42,599 participants (median age, 65 years; 46.6% men) from the UK Biobank who underwent abdominal Dixon MRI.
• IPFD levels were measured using MRI and a deep learning-based framework called nnUNet.
• The outcomes assessed in this study were diseases of the exocrine pancreas and endocrine pancreas, including acute pancreatitis, pancreatic cancer, diabetes, and other pancreatic conditions.

TAKEAWAY:

• The prevalence of FP was 17.86%.
• Elevation in IPFD levels by one quintile increased the risk for the development of acute pancreatitis by 51.3% (P = .001), pancreatic cancer by 36.5% (P = .017), diabetes by 22.1% (P < .001), and all pancreatic diseases by 22.7% (P < .001).
• FP increased the risk for acute pancreatitis by 298.2% (P < .001), pancreatic cancer by 97.6% (P = .034), diabetes by 33.7% (P = .001), and all pancreatic diseases by 44.1% (P < .001).
• An increasing trend in the prevalence of FP with advancing age was observed in both men and women.

IN PRACTICE:

“FP is a common pancreatic disorder. Fat in the pancreas is an independent risk factor for diseases of both the exocrine pancreas and endocrine pancreas,” the authors wrote.

SOURCE:

This study, led by Xiaowu Dong, MD, of the Pancreatic Center, Department of Gastroenterology, Yangzhou Key Laboratory of Pancreatic Disease, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

The authors acknowledged that most of the enrolled participants were White and older than 45 years. A low response rate to recruitment invitations in the UK Biobank database may have introduced self-selection bias. The median follow-up duration of 4.61 years was short and may be insufficient to fully capture the impact of IPFD. Additionally, the use of the average fat fraction for the entire pancreas may have led to spatial variations being ignored.

DISCLOSURES:

This work was supported by the National Natural Science Foundation of China, Cultivation Foundation of Yangzhou Municipal Key Laboratory, The Medical Research Project of Jiangsu Provincial Health Commission, Yangzhou key research and development plan, and Suzhou Innovation Platform Construction Projects-Municipal Key Laboratory Construction. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Moderate to vigorous aerobic physical activity performed in the evening is associated with the lowest risk for mortality, cardiovascular disease (CVD), and microvascular disease (MVD) in adults with obesity, including those with type 2 diabetes (T2D).

METHODOLOGY:

• Bouts of moderate to vigorous aerobic physical activity are widely recognized to improve cardiometabolic risk factors, but whether morning, afternoon, or evening timing may lead to greater improvements is unclear.
• Researchers analyzed UK Biobank data of 29,836 participants with obesity (body mass index, › 30; mean age, 62.2 years; 53.2% women), including 2995 also diagnosed with T2D, all enrolled in 2006-2010.
• Aerobic activity was defined as bouts lasting ≥ 3 minutes, and the intensity of activity was classified as light, moderate, or vigorous using accelerometer data collected from participants.
• Participants were stratified into the morning (6 a.m. to < 12 p.m.), afternoon (12 p.m. to < 6 p.m.), and evening (6 p.m. to < 12 a.m.) groups based on when > 50% of their total moderate to vigorous activity occurred, and those with no aerobic bouts were considered the reference group.
• The association between the timing of aerobic physical activity and risk for all-cause mortality, CVD (defined as circulatory, such as hypertension), and MVD (neuropathy, nephropathy, or retinopathy) was evaluated over a median follow-up of 7.9 years.

TAKEAWAY:

• Mortality risk was lowest in the evening moderate to vigorous physical activity group (hazard ratio [HR], 0.39; 95% CI, 0.27-0.55) and even lower in the T2D subgroup (HR, 0.24; 95% CI, 0.08-0.76) than in the reference group.
• Mortality risk was lower in the afternoon (HR, 0.60; 95% CI, 0.51-0.71) and morning (HR, 0.67; 95% CI, 0.56-0.79) activity groups than in the reference group, but this association was weaker than that observed in the evening activity group.
• The evening moderate to vigorous activity group had a lower risk for CVD (HR, 0.64; 95% CI, 0.54-0.75) and MVD (HR, 0.76; 95% CI, 0.63-0.92) than the reference group.
• Among participants with obesity and T2D, moderate to vigorous physical activity in the evening was associated with a lower risk for mortality, CVD, and MVD.

IN PRACTICE:

The authors wrote, “The results of this study emphasize that beyond the total volume of MVPA [moderate to vigorous physical activity], its timing, particularly in the evening, was consistently associated with the lowest risk of mortality relative to other timing windows.”

SOURCE:

The study, led by Angelo Sabag, PhD, Charles Perkins Centre, University of Sydney, Australia, was published online in Diabetes Care.

LIMITATIONS:

Because this was an observational study, the possibility of reverse causation from prodromal disease and unaccounted confounding factors could not have been ruled out. There was a lag of a median of 5.5 years between the UK Biobank baseline, when covariate measurements were taken, and the accelerometry study. Moreover, the response rate of the UK Biobank was low.

DISCLOSURES:

The study was funded by an Australian National Health and Medical Research Council Investigator Grant and the National Heart Foundation of Australia Postdoctoral Fellowship. The authors reported no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Moderate to vigorous aerobic physical activity performed in the evening is associated with the lowest risk for mortality, cardiovascular disease (CVD), and microvascular disease (MVD) in adults with obesity, including those with type 2 diabetes (T2D).

METHODOLOGY:

• Bouts of moderate to vigorous aerobic physical activity are widely recognized to improve cardiometabolic risk factors, but whether morning, afternoon, or evening timing may lead to greater improvements is unclear.
• Researchers analyzed UK Biobank data of 29,836 participants with obesity (body mass index, › 30; mean age, 62.2 years; 53.2% women), including 2995 also diagnosed with T2D, all enrolled in 2006-2010.
• Aerobic activity was defined as bouts lasting ≥ 3 minutes, and the intensity of activity was classified as light, moderate, or vigorous using accelerometer data collected from participants.
• Participants were stratified into the morning (6 a.m. to < 12 p.m.), afternoon (12 p.m. to < 6 p.m.), and evening (6 p.m. to < 12 a.m.) groups based on when > 50% of their total moderate to vigorous activity occurred, and those with no aerobic bouts were considered the reference group.
• The association between the timing of aerobic physical activity and risk for all-cause mortality, CVD (defined as circulatory, such as hypertension), and MVD (neuropathy, nephropathy, or retinopathy) was evaluated over a median follow-up of 7.9 years.

TAKEAWAY:

• Mortality risk was lowest in the evening moderate to vigorous physical activity group (hazard ratio [HR], 0.39; 95% CI, 0.27-0.55) and even lower in the T2D subgroup (HR, 0.24; 95% CI, 0.08-0.76) than in the reference group.
• Mortality risk was lower in the afternoon (HR, 0.60; 95% CI, 0.51-0.71) and morning (HR, 0.67; 95% CI, 0.56-0.79) activity groups than in the reference group, but this association was weaker than that observed in the evening activity group.
• The evening moderate to vigorous activity group had a lower risk for CVD (HR, 0.64; 95% CI, 0.54-0.75) and MVD (HR, 0.76; 95% CI, 0.63-0.92) than the reference group.
• Among participants with obesity and T2D, moderate to vigorous physical activity in the evening was associated with a lower risk for mortality, CVD, and MVD.

IN PRACTICE:

The authors wrote, “The results of this study emphasize that beyond the total volume of MVPA [moderate to vigorous physical activity], its timing, particularly in the evening, was consistently associated with the lowest risk of mortality relative to other timing windows.”

SOURCE:

The study, led by Angelo Sabag, PhD, Charles Perkins Centre, University of Sydney, Australia, was published online in Diabetes Care.

LIMITATIONS:

Because this was an observational study, the possibility of reverse causation from prodromal disease and unaccounted confounding factors could not have been ruled out. There was a lag of a median of 5.5 years between the UK Biobank baseline, when covariate measurements were taken, and the accelerometry study. Moreover, the response rate of the UK Biobank was low.

DISCLOSURES:

The study was funded by an Australian National Health and Medical Research Council Investigator Grant and the National Heart Foundation of Australia Postdoctoral Fellowship. The authors reported no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Moderate to vigorous aerobic physical activity performed in the evening is associated with the lowest risk for mortality, cardiovascular disease (CVD), and microvascular disease (MVD) in adults with obesity, including those with type 2 diabetes (T2D).

METHODOLOGY:

• Bouts of moderate to vigorous aerobic physical activity are widely recognized to improve cardiometabolic risk factors, but whether morning, afternoon, or evening timing may lead to greater improvements is unclear.
• Researchers analyzed UK Biobank data of 29,836 participants with obesity (body mass index, › 30; mean age, 62.2 years; 53.2% women), including 2995 also diagnosed with T2D, all enrolled in 2006-2010.
• Aerobic activity was defined as bouts lasting ≥ 3 minutes, and the intensity of activity was classified as light, moderate, or vigorous using accelerometer data collected from participants.
• Participants were stratified into the morning (6 a.m. to < 12 p.m.), afternoon (12 p.m. to < 6 p.m.), and evening (6 p.m. to < 12 a.m.) groups based on when > 50% of their total moderate to vigorous activity occurred, and those with no aerobic bouts were considered the reference group.
• The association between the timing of aerobic physical activity and risk for all-cause mortality, CVD (defined as circulatory, such as hypertension), and MVD (neuropathy, nephropathy, or retinopathy) was evaluated over a median follow-up of 7.9 years.

TAKEAWAY:

• Mortality risk was lowest in the evening moderate to vigorous physical activity group (hazard ratio [HR], 0.39; 95% CI, 0.27-0.55) and even lower in the T2D subgroup (HR, 0.24; 95% CI, 0.08-0.76) than in the reference group.
• Mortality risk was lower in the afternoon (HR, 0.60; 95% CI, 0.51-0.71) and morning (HR, 0.67; 95% CI, 0.56-0.79) activity groups than in the reference group, but this association was weaker than that observed in the evening activity group.
• The evening moderate to vigorous activity group had a lower risk for CVD (HR, 0.64; 95% CI, 0.54-0.75) and MVD (HR, 0.76; 95% CI, 0.63-0.92) than the reference group.
• Among participants with obesity and T2D, moderate to vigorous physical activity in the evening was associated with a lower risk for mortality, CVD, and MVD.

IN PRACTICE:

The authors wrote, “The results of this study emphasize that beyond the total volume of MVPA [moderate to vigorous physical activity], its timing, particularly in the evening, was consistently associated with the lowest risk of mortality relative to other timing windows.”

SOURCE:

The study, led by Angelo Sabag, PhD, Charles Perkins Centre, University of Sydney, Australia, was published online in Diabetes Care.

LIMITATIONS:

Because this was an observational study, the possibility of reverse causation from prodromal disease and unaccounted confounding factors could not have been ruled out. There was a lag of a median of 5.5 years between the UK Biobank baseline, when covariate measurements were taken, and the accelerometry study. Moreover, the response rate of the UK Biobank was low.

DISCLOSURES:

The study was funded by an Australian National Health and Medical Research Council Investigator Grant and the National Heart Foundation of Australia Postdoctoral Fellowship. The authors reported no conflicts of interest.

A version of this article appeared on Medscape.com.

With all the excitement about GLP-1 agonists, I get many questions from providers about which antiobesity drug they should prescribe. I’ll tell you the methods that I use to determine which drug is best for which patient.

Of course, we want to make sure that we’re treating the right condition. If the patient has type 2 diabetes, we tend to give them medication that is indicated for type 2 diabetes. Many GLP-1 agonists are available in a diabetes version and a chronic weight management or obesity version. If a patient has diabetes and obesity, they can receive either one. If a patient has only diabetes but not obesity, they should be prescribed the diabetes version. For obesity without diabetes, we tend to stick with the drugs that are indicated for chronic weight management.

Let’s go through them.

Exenatide. In chronological order of approval, the first GLP-1 drug that was used for diabetes dates back to exenatide (Bydureon). Bydureon had a partner called Byetta (also exenatide), both of which are still on the market but infrequently used. Some patients reported that these medications were inconvenient because they required twice-daily injections and caused painful injection-site nodules.

Diabetes drugs in more common use include liraglutide (Victoza) for type 2 diabetes. It is a daily injection and has various doses. We always start low and increase with tolerance and desired effect for A1c.

Liraglutide. Victoza has an antiobesity counterpart called Saxenda. The Saxenda pen looks very similar to the Victoza pen. It is a daily GLP-1 agonist for chronic weight management. The SCALE trial demonstrated 8%-12% weight loss with Saxenda.

Those are the daily injections: Victoza for diabetes and Saxenda for weight loss.

Our patients are very excited about the advent of weekly injections for diabetes and weight management. Ozempic is very popular. It is a weekly GLP-1 agonist for type 2 diabetes. Many patients come in asking for Ozempic, and we must make sure that we’re moving them in the right direction depending on their condition.

Semaglutide. Ozempic has a few different doses. It is a weekly injection and has been found to be quite efficacious for treating diabetes. The drug’s weight loss counterpart is called Wegovy, which comes in a different pen. Both forms contain the compound semaglutide. While all of these GLP-1 agonists are indicated to treat type 2 diabetes or for weight management, Wegovy has a special indication that none of the others have. In March 2024, Wegovy acquired an indication to decrease cardiac risk in those with a BMI ≥ 27 and a previous cardiac history. This will really change the accessibility of this medication because patients with heart conditions who are on Medicare are expected to have access to Wegovy.

Tirzepatide. Another weekly injection for treatment of type 2 diabetes is called Mounjaro. Its counterpart for weight management is called Zepbound, which was found to have about 20.9% weight loss over 72 weeks. These medications have similar side effects in differing degrees, but the most-often reported are nausea, stool changes, abdominal pain, and reflux. There are some other potential side effects; I recommend that you read the individual prescribing information available for each drug to have more clarity about that.

It is important that we stay on label for using the GLP-1 receptor agonists, for many reasons. One, it increases our patients’ accessibility to the right medication for them, and we can also make sure that we’re treating the patient with the right drug according to the clinical trials. When the clinical trials are done, the study populations demonstrate safety and efficacy for that population. But if we’re prescribing a GLP-1 for a different population, it is considered off-label use.
 

Dr. Lofton, an obesity medicine specialist, is clinical associate professor of surgery and medicine at NYU Grossman School of Medicine, and director of the medical weight management program at NYU Langone Weight Management Center, New York. She disclosed ties to Novo Nordisk and Eli Lilly. This transcript has been edited for clarity.

A version of this article appeared on Medscape.com.

With all the excitement about GLP-1 agonists, I get many questions from providers about which antiobesity drug they should prescribe. I’ll tell you the methods that I use to determine which drug is best for which patient.

Of course, we want to make sure that we’re treating the right condition. If the patient has type 2 diabetes, we tend to give them medication that is indicated for type 2 diabetes. Many GLP-1 agonists are available in a diabetes version and a chronic weight management or obesity version. If a patient has diabetes and obesity, they can receive either one. If a patient has only diabetes but not obesity, they should be prescribed the diabetes version. For obesity without diabetes, we tend to stick with the drugs that are indicated for chronic weight management.

Let’s go through them.

Exenatide. In chronological order of approval, the first GLP-1 drug that was used for diabetes dates back to exenatide (Bydureon). Bydureon had a partner called Byetta (also exenatide), both of which are still on the market but infrequently used. Some patients reported that these medications were inconvenient because they required twice-daily injections and caused painful injection-site nodules.

Diabetes drugs in more common use include liraglutide (Victoza) for type 2 diabetes. It is a daily injection and has various doses. We always start low and increase with tolerance and desired effect for A1c.

Liraglutide. Victoza has an antiobesity counterpart called Saxenda. The Saxenda pen looks very similar to the Victoza pen. It is a daily GLP-1 agonist for chronic weight management. The SCALE trial demonstrated 8%-12% weight loss with Saxenda.

Those are the daily injections: Victoza for diabetes and Saxenda for weight loss.

Our patients are very excited about the advent of weekly injections for diabetes and weight management. Ozempic is very popular. It is a weekly GLP-1 agonist for type 2 diabetes. Many patients come in asking for Ozempic, and we must make sure that we’re moving them in the right direction depending on their condition.

Semaglutide. Ozempic has a few different doses. It is a weekly injection and has been found to be quite efficacious for treating diabetes. The drug’s weight loss counterpart is called Wegovy, which comes in a different pen. Both forms contain the compound semaglutide. While all of these GLP-1 agonists are indicated to treat type 2 diabetes or for weight management, Wegovy has a special indication that none of the others have. In March 2024, Wegovy acquired an indication to decrease cardiac risk in those with a BMI ≥ 27 and a previous cardiac history. This will really change the accessibility of this medication because patients with heart conditions who are on Medicare are expected to have access to Wegovy.

Tirzepatide. Another weekly injection for treatment of type 2 diabetes is called Mounjaro. Its counterpart for weight management is called Zepbound, which was found to have about 20.9% weight loss over 72 weeks. These medications have similar side effects in differing degrees, but the most-often reported are nausea, stool changes, abdominal pain, and reflux. There are some other potential side effects; I recommend that you read the individual prescribing information available for each drug to have more clarity about that.

It is important that we stay on label for using the GLP-1 receptor agonists, for many reasons. One, it increases our patients’ accessibility to the right medication for them, and we can also make sure that we’re treating the patient with the right drug according to the clinical trials. When the clinical trials are done, the study populations demonstrate safety and efficacy for that population. But if we’re prescribing a GLP-1 for a different population, it is considered off-label use.
 

Dr. Lofton, an obesity medicine specialist, is clinical associate professor of surgery and medicine at NYU Grossman School of Medicine, and director of the medical weight management program at NYU Langone Weight Management Center, New York. She disclosed ties to Novo Nordisk and Eli Lilly. This transcript has been edited for clarity.

A version of this article appeared on Medscape.com.

With all the excitement about GLP-1 agonists, I get many questions from providers about which antiobesity drug they should prescribe. I’ll tell you the methods that I use to determine which drug is best for which patient.

Of course, we want to make sure that we’re treating the right condition. If the patient has type 2 diabetes, we tend to give them medication that is indicated for type 2 diabetes. Many GLP-1 agonists are available in a diabetes version and a chronic weight management or obesity version. If a patient has diabetes and obesity, they can receive either one. If a patient has only diabetes but not obesity, they should be prescribed the diabetes version. For obesity without diabetes, we tend to stick with the drugs that are indicated for chronic weight management.

Let’s go through them.

Exenatide. In chronological order of approval, the first GLP-1 drug that was used for diabetes dates back to exenatide (Bydureon). Bydureon had a partner called Byetta (also exenatide), both of which are still on the market but infrequently used. Some patients reported that these medications were inconvenient because they required twice-daily injections and caused painful injection-site nodules.

Diabetes drugs in more common use include liraglutide (Victoza) for type 2 diabetes. It is a daily injection and has various doses. We always start low and increase with tolerance and desired effect for A1c.

Liraglutide. Victoza has an antiobesity counterpart called Saxenda. The Saxenda pen looks very similar to the Victoza pen. It is a daily GLP-1 agonist for chronic weight management. The SCALE trial demonstrated 8%-12% weight loss with Saxenda.

Those are the daily injections: Victoza for diabetes and Saxenda for weight loss.

Our patients are very excited about the advent of weekly injections for diabetes and weight management. Ozempic is very popular. It is a weekly GLP-1 agonist for type 2 diabetes. Many patients come in asking for Ozempic, and we must make sure that we’re moving them in the right direction depending on their condition.

Semaglutide. Ozempic has a few different doses. It is a weekly injection and has been found to be quite efficacious for treating diabetes. The drug’s weight loss counterpart is called Wegovy, which comes in a different pen. Both forms contain the compound semaglutide. While all of these GLP-1 agonists are indicated to treat type 2 diabetes or for weight management, Wegovy has a special indication that none of the others have. In March 2024, Wegovy acquired an indication to decrease cardiac risk in those with a BMI ≥ 27 and a previous cardiac history. This will really change the accessibility of this medication because patients with heart conditions who are on Medicare are expected to have access to Wegovy.

Tirzepatide. Another weekly injection for treatment of type 2 diabetes is called Mounjaro. Its counterpart for weight management is called Zepbound, which was found to have about 20.9% weight loss over 72 weeks. These medications have similar side effects in differing degrees, but the most-often reported are nausea, stool changes, abdominal pain, and reflux. There are some other potential side effects; I recommend that you read the individual prescribing information available for each drug to have more clarity about that.

It is important that we stay on label for using the GLP-1 receptor agonists, for many reasons. One, it increases our patients’ accessibility to the right medication for them, and we can also make sure that we’re treating the patient with the right drug according to the clinical trials. When the clinical trials are done, the study populations demonstrate safety and efficacy for that population. But if we’re prescribing a GLP-1 for a different population, it is considered off-label use.
 

Dr. Lofton, an obesity medicine specialist, is clinical associate professor of surgery and medicine at NYU Grossman School of Medicine, and director of the medical weight management program at NYU Langone Weight Management Center, New York. She disclosed ties to Novo Nordisk and Eli Lilly. This transcript has been edited for clarity.

A version of this article appeared on Medscape.com.

LONDON — Weight loss, glycemic control, fatty liver, and the need for insulin all showed improvement in patients with both refractory type 2 diabetes and obesity after a gut liner known as EndoBarrier (RESET, Morphic Medical, United States) was implanted for 1 year, showed data.

Two years after the liner’s removal, 80% of patients continued to show significant improvement, while 20% returned to baseline.

Presenting results at the Diabetes UK Professional Conference (DUKPC) 2024, the researchers, led by Bob Ryder, MD, FRCP, from the Department of Diabetes, Birmingham City Hospital, Birmingham, England, aimed to assess the safety and efficacy of EndoBarrier, as well as maintenance of efficacy 24 months after the device removal.

“We think EndoBarrier finds its place between the end of all the earlier measures and the possible option of bariatric surgery, and these data show that it can lead to tremendous weight loss and improvement in A1c,” Dr. Ryder said in an interview.

Commenting on how most patients had responded to use of the device, Dr. Ryder said, “People with obesity are often very unhappy and have tried everything over many years to no effect; however, this gut liner provided the opportunity to shift out of this state, and they often become so happy with the result they were determined to stick with it and continue with a healthier lifestyle including much more exercise.”
 

Convenient, Reversible Procedure

Ninety consecutive patients from Birmingham, all with longstanding, poorly controlled, type 2 diabetes and obesity, underwent the implantation procedure, and 60 of these attended follow-up visits 2 years post implantation.

Unlike permanent and more invasive weight loss surgeries, the EndoBarrier device is reversible and fitted with a straightforward procedure.

The thin impermeable sleeve is inserted via an approximate 1-hour endoscopy, enabling the patient to return home the same day. It lines the first 60 cm of the small intestine. Digested food passes through it without absorption and then makes contact with pancreatic and bile juices at the other end. This triggers a change in the metabolism of glucose and nutrients through modulating gut hormones and gut bacteria, as well as disrupting bile flow.

“Because the food bypasses the small intestine, the first time the food is encountered is in an area where it is not normally found, and this causes a reaction where signals are sent to the brain to stop eating,” explained Dr. Ryder.

Due to a license for 1 year of use, the gut liner was removed after a year via a 30-minute endoscopy procedure.
 

Over Half Maintained Full Improvement 2 Years Post Removal

A total of 60/90 (66%) attended follow-up visits and comprised the data presented. Mean age was 51.2 years, 47% were men, 50% were White, mean body mass index (BMI) was 41.5 kg/m², and mean A1c was 9.3%. Duration of type 2 diabetes was a median of 11 years, and 60% were taking insulin.

Patients followed dietary requirements for the initial phase after implantation. “During the first week, they followed a liquid diet, then during week 2 — mushy food, and then they were told to chew it really well to avoid blockage,” said Dr. Ryder.

Mean weight loss on removal of the liner (at 12 months post implantation) was 16.7 kg (P < .001), while BMI dropped by mean 6 kg/m², A1c dropped by a mean of 1.8%, and mean systolic blood pressure by 10.9 mm Hg.

Just over half (32/60, 53%) showed maintenance of fully sustained improvement 2 years after removal of the liner — defined as no significant difference after 2 years between weight loss (mean, 96-97 kg) and similarly for A1c improvement (7.6%-7.4%).

Sixteen of 60 (27%) showed partially sustained improvement over the 2 years of follow-up, with BMI increasing from a mean of 116.8 kg to 128.6 kg and A1c increasing from 7.5% to 8.4%. While 20% (12/60) returned to baseline.

Of the 36/60 people using insulin prior to EndoBarrier treatment, 10 (27.8%) were no longer using insulin at 2 years post removal.

Thirteen of 90 (14%) had early removal of the gut liner due to gastrointestinal hemorrhage (five), liver abscess (two), other abscess (one), and gastrointestinal symptoms (five), but they all made a full recovery; after removal, most experienced benefit despite the adverse event, reported Dr. Ryder.

Sarah Davies, MBBCh, a GP at Woodlands Medical Centre, Cardiff, Wales, agreed that EndoBarrier might be a viable option for patients struggling with obesity. “As GPs, we are the first port of call for these patients. It’s very novel, I hadn’t heard of it before. I like how it’s a noninvasive way for my patients to lose weight and maintain that even after EndoBarrier has been removed.”

Outcomes are being monitored in an ongoing global registry to help determine if EndoBarrier is a safe and effective treatment for individuals with type 2 diabetes and obesity. Dr. Ryder noted that a similar study with 3 years of follow-up showed similar results. Further results will be presented by Dr. Ryder at the upcoming meeting of the American Diabetes Association.

EndoBarrier is currently not approved in the United States. It is awaiting United Kingdom and European CE mark, which the manufacturer hope will be granted this summer. The license will be for patients with BMI of 35-50 kg/m².
 

A version of this article appeared on Medscape.com.

LONDON — Weight loss, glycemic control, fatty liver, and the need for insulin all showed improvement in patients with both refractory type 2 diabetes and obesity after a gut liner known as EndoBarrier (RESET, Morphic Medical, United States) was implanted for 1 year, showed data.

Two years after the liner’s removal, 80% of patients continued to show significant improvement, while 20% returned to baseline.

Presenting results at the Diabetes UK Professional Conference (DUKPC) 2024, the researchers, led by Bob Ryder, MD, FRCP, from the Department of Diabetes, Birmingham City Hospital, Birmingham, England, aimed to assess the safety and efficacy of EndoBarrier, as well as maintenance of efficacy 24 months after the device removal.

“We think EndoBarrier finds its place between the end of all the earlier measures and the possible option of bariatric surgery, and these data show that it can lead to tremendous weight loss and improvement in A1c,” Dr. Ryder said in an interview.

Commenting on how most patients had responded to use of the device, Dr. Ryder said, “People with obesity are often very unhappy and have tried everything over many years to no effect; however, this gut liner provided the opportunity to shift out of this state, and they often become so happy with the result they were determined to stick with it and continue with a healthier lifestyle including much more exercise.”
 

Convenient, Reversible Procedure

Ninety consecutive patients from Birmingham, all with longstanding, poorly controlled, type 2 diabetes and obesity, underwent the implantation procedure, and 60 of these attended follow-up visits 2 years post implantation.

Unlike permanent and more invasive weight loss surgeries, the EndoBarrier device is reversible and fitted with a straightforward procedure.

The thin impermeable sleeve is inserted via an approximate 1-hour endoscopy, enabling the patient to return home the same day. It lines the first 60 cm of the small intestine. Digested food passes through it without absorption and then makes contact with pancreatic and bile juices at the other end. This triggers a change in the metabolism of glucose and nutrients through modulating gut hormones and gut bacteria, as well as disrupting bile flow.

“Because the food bypasses the small intestine, the first time the food is encountered is in an area where it is not normally found, and this causes a reaction where signals are sent to the brain to stop eating,” explained Dr. Ryder.

Due to a license for 1 year of use, the gut liner was removed after a year via a 30-minute endoscopy procedure.
 

Over Half Maintained Full Improvement 2 Years Post Removal

A total of 60/90 (66%) attended follow-up visits and comprised the data presented. Mean age was 51.2 years, 47% were men, 50% were White, mean body mass index (BMI) was 41.5 kg/m², and mean A1c was 9.3%. Duration of type 2 diabetes was a median of 11 years, and 60% were taking insulin.

Patients followed dietary requirements for the initial phase after implantation. “During the first week, they followed a liquid diet, then during week 2 — mushy food, and then they were told to chew it really well to avoid blockage,” said Dr. Ryder.

Mean weight loss on removal of the liner (at 12 months post implantation) was 16.7 kg (P < .001), while BMI dropped by mean 6 kg/m², A1c dropped by a mean of 1.8%, and mean systolic blood pressure by 10.9 mm Hg.

Just over half (32/60, 53%) showed maintenance of fully sustained improvement 2 years after removal of the liner — defined as no significant difference after 2 years between weight loss (mean, 96-97 kg) and similarly for A1c improvement (7.6%-7.4%).

Sixteen of 60 (27%) showed partially sustained improvement over the 2 years of follow-up, with BMI increasing from a mean of 116.8 kg to 128.6 kg and A1c increasing from 7.5% to 8.4%. While 20% (12/60) returned to baseline.

Of the 36/60 people using insulin prior to EndoBarrier treatment, 10 (27.8%) were no longer using insulin at 2 years post removal.

Thirteen of 90 (14%) had early removal of the gut liner due to gastrointestinal hemorrhage (five), liver abscess (two), other abscess (one), and gastrointestinal symptoms (five), but they all made a full recovery; after removal, most experienced benefit despite the adverse event, reported Dr. Ryder.

Sarah Davies, MBBCh, a GP at Woodlands Medical Centre, Cardiff, Wales, agreed that EndoBarrier might be a viable option for patients struggling with obesity. “As GPs, we are the first port of call for these patients. It’s very novel, I hadn’t heard of it before. I like how it’s a noninvasive way for my patients to lose weight and maintain that even after EndoBarrier has been removed.”

Outcomes are being monitored in an ongoing global registry to help determine if EndoBarrier is a safe and effective treatment for individuals with type 2 diabetes and obesity. Dr. Ryder noted that a similar study with 3 years of follow-up showed similar results. Further results will be presented by Dr. Ryder at the upcoming meeting of the American Diabetes Association.

EndoBarrier is currently not approved in the United States. It is awaiting United Kingdom and European CE mark, which the manufacturer hope will be granted this summer. The license will be for patients with BMI of 35-50 kg/m².
 

A version of this article appeared on Medscape.com.

LONDON — Weight loss, glycemic control, fatty liver, and the need for insulin all showed improvement in patients with both refractory type 2 diabetes and obesity after a gut liner known as EndoBarrier (RESET, Morphic Medical, United States) was implanted for 1 year, showed data.

Two years after the liner’s removal, 80% of patients continued to show significant improvement, while 20% returned to baseline.

Presenting results at the Diabetes UK Professional Conference (DUKPC) 2024, the researchers, led by Bob Ryder, MD, FRCP, from the Department of Diabetes, Birmingham City Hospital, Birmingham, England, aimed to assess the safety and efficacy of EndoBarrier, as well as maintenance of efficacy 24 months after the device removal.

“We think EndoBarrier finds its place between the end of all the earlier measures and the possible option of bariatric surgery, and these data show that it can lead to tremendous weight loss and improvement in A1c,” Dr. Ryder said in an interview.

Commenting on how most patients had responded to use of the device, Dr. Ryder said, “People with obesity are often very unhappy and have tried everything over many years to no effect; however, this gut liner provided the opportunity to shift out of this state, and they often become so happy with the result they were determined to stick with it and continue with a healthier lifestyle including much more exercise.”
 

Convenient, Reversible Procedure

Ninety consecutive patients from Birmingham, all with longstanding, poorly controlled, type 2 diabetes and obesity, underwent the implantation procedure, and 60 of these attended follow-up visits 2 years post implantation.

Unlike permanent and more invasive weight loss surgeries, the EndoBarrier device is reversible and fitted with a straightforward procedure.

The thin impermeable sleeve is inserted via an approximate 1-hour endoscopy, enabling the patient to return home the same day. It lines the first 60 cm of the small intestine. Digested food passes through it without absorption and then makes contact with pancreatic and bile juices at the other end. This triggers a change in the metabolism of glucose and nutrients through modulating gut hormones and gut bacteria, as well as disrupting bile flow.

“Because the food bypasses the small intestine, the first time the food is encountered is in an area where it is not normally found, and this causes a reaction where signals are sent to the brain to stop eating,” explained Dr. Ryder.

Due to a license for 1 year of use, the gut liner was removed after a year via a 30-minute endoscopy procedure.
 

Over Half Maintained Full Improvement 2 Years Post Removal

A total of 60/90 (66%) attended follow-up visits and comprised the data presented. Mean age was 51.2 years, 47% were men, 50% were White, mean body mass index (BMI) was 41.5 kg/m², and mean A1c was 9.3%. Duration of type 2 diabetes was a median of 11 years, and 60% were taking insulin.

Patients followed dietary requirements for the initial phase after implantation. “During the first week, they followed a liquid diet, then during week 2 — mushy food, and then they were told to chew it really well to avoid blockage,” said Dr. Ryder.

Mean weight loss on removal of the liner (at 12 months post implantation) was 16.7 kg (P < .001), while BMI dropped by mean 6 kg/m², A1c dropped by a mean of 1.8%, and mean systolic blood pressure by 10.9 mm Hg.

Just over half (32/60, 53%) showed maintenance of fully sustained improvement 2 years after removal of the liner — defined as no significant difference after 2 years between weight loss (mean, 96-97 kg) and similarly for A1c improvement (7.6%-7.4%).

Sixteen of 60 (27%) showed partially sustained improvement over the 2 years of follow-up, with BMI increasing from a mean of 116.8 kg to 128.6 kg and A1c increasing from 7.5% to 8.4%. While 20% (12/60) returned to baseline.

Of the 36/60 people using insulin prior to EndoBarrier treatment, 10 (27.8%) were no longer using insulin at 2 years post removal.

Thirteen of 90 (14%) had early removal of the gut liner due to gastrointestinal hemorrhage (five), liver abscess (two), other abscess (one), and gastrointestinal symptoms (five), but they all made a full recovery; after removal, most experienced benefit despite the adverse event, reported Dr. Ryder.

Sarah Davies, MBBCh, a GP at Woodlands Medical Centre, Cardiff, Wales, agreed that EndoBarrier might be a viable option for patients struggling with obesity. “As GPs, we are the first port of call for these patients. It’s very novel, I hadn’t heard of it before. I like how it’s a noninvasive way for my patients to lose weight and maintain that even after EndoBarrier has been removed.”

Outcomes are being monitored in an ongoing global registry to help determine if EndoBarrier is a safe and effective treatment for individuals with type 2 diabetes and obesity. Dr. Ryder noted that a similar study with 3 years of follow-up showed similar results. Further results will be presented by Dr. Ryder at the upcoming meeting of the American Diabetes Association.

EndoBarrier is currently not approved in the United States. It is awaiting United Kingdom and European CE mark, which the manufacturer hope will be granted this summer. The license will be for patients with BMI of 35-50 kg/m².
 

A version of this article appeared on Medscape.com.

Here’s a new direction for smartphones in healthcare. 

Researchers from the National Institute of Standards and Technology (NIST), Boulder, Colorado, say a smartphone compass could be used to analyze biomarkers in body fluids — blood, sweat, urine, or saliva — to monitor or diagnose disease.

“We’re just at this point demonstrating this new way of sensing that we hope [will be] very accessible and very portable,” said Gary Zabow, PhD, a group leader in the applied physics division at NIST who supervised the research. 

In a proof-of-concept study, the researchers measured glucose levels in sangria, pinot grigio, and champagne. The detection limit reached micromolar concentrations — on par with or better than some widely used glucose sensors, such as continuous glucose monitors. They also accurately measured the pH levels of coffee, orange juice, and root beer.

More tests are needed to confirm the method works in biological fluids, so it could be a while before it’s available for clinical or commercial use. 

Still, the prospect is “exciting,” said Aydogan Ozcan, PhD, a bioengineering professor at the University of California, Los Angeles, who was not involved in the study. “It might enable new capabilities for advanced sensing applications in field settings or even at home.”

The advance builds on growing research using smartphones to put powerful medical devices in patients’ hands. A new AI-powered app can use a smartphone camera to detect skin cancer, while other apps administer cognitive tests to detect dementia. Smartphone cameras can even be harnessed for “advanced optical microscopes and sensors to the level where we could even see and detect individual DNA molecules with inexpensive optical attachments,” Dr. Ozcan said. More than six billion people worldwide own a smartphone.

The compass inside smartphones is a magnetometer — it measures magnetic fields. Normally it detects the earth’s magnetic fields, but it can also detect small, nearby magnets and changes in those magnets’ positions. 

The researchers embedded a small magnet inside a strip of “smart hydrogel — a piece of material that expands or contracts” when immersed in a solution, said Dr. Zabow.

As the hydrogel gets bigger or smaller, it moves the magnet, Dr. Zabow explained. For example, if the hydrogel is designed to expand when the solution is acidic or contract when it’s basic, it can move the magnet closer or farther from the phone’s magnetometer, providing an indicator of pH. For glucose, the hydrogel expands or contracts depending on the concentration of sugar in the liquid.

With some calibration and coding to translate that reading into a number, “you can effectively read out glucose or pH,” Dr. Zabow said.

Only a small strip of hydrogel is needed, “like a pH test strip that you use for a pool,” said first study author Mark Ferris, PhD, a postdoctoral researcher at NIST. 

Like a pool pH test strip, this test is meant to be “easy to use, and at that kind of price,” Dr. Ferris said. “It’s supposed to be something that’s cheap and disposable.” Each pH hydrogel strip is about 3 cents, and glucose strips are 16 cents, Dr. Ferris estimated. In bulk, those prices could go down.

Next the team plans to test the strips with biological fluids. But complex fluids like blood could pose a challenge, as other molecules present could react with the strip and affect the results. “It may be that you need to tweak the chemistry of the hydrogel to make sure it is really specific to one biomolecule and there is no interference from other biomolecules,” Dr. Zabow said.

The technique could be adapted to detect other biomarkers or molecules, the researchers said. It could also be used to check for chemical contaminants in tap, lake, or stream water. 
 

A version of this article appeared on Medscape.com.

Here’s a new direction for smartphones in healthcare. 

Researchers from the National Institute of Standards and Technology (NIST), Boulder, Colorado, say a smartphone compass could be used to analyze biomarkers in body fluids — blood, sweat, urine, or saliva — to monitor or diagnose disease.

“We’re just at this point demonstrating this new way of sensing that we hope [will be] very accessible and very portable,” said Gary Zabow, PhD, a group leader in the applied physics division at NIST who supervised the research. 

In a proof-of-concept study, the researchers measured glucose levels in sangria, pinot grigio, and champagne. The detection limit reached micromolar concentrations — on par with or better than some widely used glucose sensors, such as continuous glucose monitors. They also accurately measured the pH levels of coffee, orange juice, and root beer.

More tests are needed to confirm the method works in biological fluids, so it could be a while before it’s available for clinical or commercial use. 

Still, the prospect is “exciting,” said Aydogan Ozcan, PhD, a bioengineering professor at the University of California, Los Angeles, who was not involved in the study. “It might enable new capabilities for advanced sensing applications in field settings or even at home.”

The advance builds on growing research using smartphones to put powerful medical devices in patients’ hands. A new AI-powered app can use a smartphone camera to detect skin cancer, while other apps administer cognitive tests to detect dementia. Smartphone cameras can even be harnessed for “advanced optical microscopes and sensors to the level where we could even see and detect individual DNA molecules with inexpensive optical attachments,” Dr. Ozcan said. More than six billion people worldwide own a smartphone.

The compass inside smartphones is a magnetometer — it measures magnetic fields. Normally it detects the earth’s magnetic fields, but it can also detect small, nearby magnets and changes in those magnets’ positions. 

The researchers embedded a small magnet inside a strip of “smart hydrogel — a piece of material that expands or contracts” when immersed in a solution, said Dr. Zabow.

As the hydrogel gets bigger or smaller, it moves the magnet, Dr. Zabow explained. For example, if the hydrogel is designed to expand when the solution is acidic or contract when it’s basic, it can move the magnet closer or farther from the phone’s magnetometer, providing an indicator of pH. For glucose, the hydrogel expands or contracts depending on the concentration of sugar in the liquid.

With some calibration and coding to translate that reading into a number, “you can effectively read out glucose or pH,” Dr. Zabow said.

Only a small strip of hydrogel is needed, “like a pH test strip that you use for a pool,” said first study author Mark Ferris, PhD, a postdoctoral researcher at NIST. 

Like a pool pH test strip, this test is meant to be “easy to use, and at that kind of price,” Dr. Ferris said. “It’s supposed to be something that’s cheap and disposable.” Each pH hydrogel strip is about 3 cents, and glucose strips are 16 cents, Dr. Ferris estimated. In bulk, those prices could go down.

Next the team plans to test the strips with biological fluids. But complex fluids like blood could pose a challenge, as other molecules present could react with the strip and affect the results. “It may be that you need to tweak the chemistry of the hydrogel to make sure it is really specific to one biomolecule and there is no interference from other biomolecules,” Dr. Zabow said.

The technique could be adapted to detect other biomarkers or molecules, the researchers said. It could also be used to check for chemical contaminants in tap, lake, or stream water. 
 

A version of this article appeared on Medscape.com.

Here’s a new direction for smartphones in healthcare. 

Researchers from the National Institute of Standards and Technology (NIST), Boulder, Colorado, say a smartphone compass could be used to analyze biomarkers in body fluids — blood, sweat, urine, or saliva — to monitor or diagnose disease.

“We’re just at this point demonstrating this new way of sensing that we hope [will be] very accessible and very portable,” said Gary Zabow, PhD, a group leader in the applied physics division at NIST who supervised the research. 

In a proof-of-concept study, the researchers measured glucose levels in sangria, pinot grigio, and champagne. The detection limit reached micromolar concentrations — on par with or better than some widely used glucose sensors, such as continuous glucose monitors. They also accurately measured the pH levels of coffee, orange juice, and root beer.

More tests are needed to confirm the method works in biological fluids, so it could be a while before it’s available for clinical or commercial use. 

Still, the prospect is “exciting,” said Aydogan Ozcan, PhD, a bioengineering professor at the University of California, Los Angeles, who was not involved in the study. “It might enable new capabilities for advanced sensing applications in field settings or even at home.”

The advance builds on growing research using smartphones to put powerful medical devices in patients’ hands. A new AI-powered app can use a smartphone camera to detect skin cancer, while other apps administer cognitive tests to detect dementia. Smartphone cameras can even be harnessed for “advanced optical microscopes and sensors to the level where we could even see and detect individual DNA molecules with inexpensive optical attachments,” Dr. Ozcan said. More than six billion people worldwide own a smartphone.

The compass inside smartphones is a magnetometer — it measures magnetic fields. Normally it detects the earth’s magnetic fields, but it can also detect small, nearby magnets and changes in those magnets’ positions. 

The researchers embedded a small magnet inside a strip of “smart hydrogel — a piece of material that expands or contracts” when immersed in a solution, said Dr. Zabow.

As the hydrogel gets bigger or smaller, it moves the magnet, Dr. Zabow explained. For example, if the hydrogel is designed to expand when the solution is acidic or contract when it’s basic, it can move the magnet closer or farther from the phone’s magnetometer, providing an indicator of pH. For glucose, the hydrogel expands or contracts depending on the concentration of sugar in the liquid.

With some calibration and coding to translate that reading into a number, “you can effectively read out glucose or pH,” Dr. Zabow said.

Only a small strip of hydrogel is needed, “like a pH test strip that you use for a pool,” said first study author Mark Ferris, PhD, a postdoctoral researcher at NIST. 

Like a pool pH test strip, this test is meant to be “easy to use, and at that kind of price,” Dr. Ferris said. “It’s supposed to be something that’s cheap and disposable.” Each pH hydrogel strip is about 3 cents, and glucose strips are 16 cents, Dr. Ferris estimated. In bulk, those prices could go down.

Next the team plans to test the strips with biological fluids. But complex fluids like blood could pose a challenge, as other molecules present could react with the strip and affect the results. “It may be that you need to tweak the chemistry of the hydrogel to make sure it is really specific to one biomolecule and there is no interference from other biomolecules,” Dr. Zabow said.

The technique could be adapted to detect other biomarkers or molecules, the researchers said. It could also be used to check for chemical contaminants in tap, lake, or stream water. 
 

A version of this article appeared on Medscape.com.

The photo of the patient’s foot, sent from his campsite, included a cheeky note: “I remember you telling me that getting in trouble doing something was better than getting in trouble doing nothing. This lets me get out there and know that I have feedback.”

The “this” was the patient’s “foot selfie,” an approach that allows patients at a risk for diabetic foot ulcers (DFUs) to snap a picture and send it to their healthcare providers for evaluation.

This particular patient had an extensive history of previous wounds. Some had essentially kept him house-bound in the past, as he was afraid to get another one.

This time, however, he got an all-clear to keep on camping, “and we scheduled him in on the following Tuesday [for follow-up],” said the camper’s physician David G. Armstrong, DPM, MD, PhD, professor of surgery and neurological surgery, USC Keck School of Medicine, Los Angeles.

Dr. Armstrong is one of the researchers evaluating the concept of foot selfies. It’s a welcome advance, he and others said, and has been shown to help heal wounds and reverse pre-ulcer lesions. Research on foot selfies continues, but much more is needed to solve the issue of DFUs, diabetic foot infections (DFIs), and the high rates of reinfection, experts know.

Worldwide, about 18.6 million people have a DFU each year, including 1.6 million in the United States. About 50%-60% of ulcers become infected, with 20% of moderate to severe infections requiring amputation of the limb. The 5-year mortality rate for DFUs is 30%, but it climbs to 70% after amputation. While about 40% of ulcers heal within 12 weeks, 42% recur at the 1-year mark, setting up a vicious and costly cycle. Healthcare costs for patients with diabetes and DFUs are five times as high as costs for patients with diabetes but no DFUs. The per capita cost to treat a DFU in America is $17,500.

While the statistics paint a grim picture, progress is being made on several fronts:

• US Food and Drug Administration (FDA) guidance on the development of drugs for DFUs, under evaluation, is forthcoming.
• New treatments are under study.
• A multidisciplinary team approach is known to improve outcomes.

Anatomy of a DFU

When neuropathy develops in those with diabetes, they no longer have what Dr. Armstrong calls the “gift” of pain perception. “They can wear a hole in their foot like you and I wear a hole in our sock or shoe,” he said. “That hole is called a diabetic foot ulcer.”

A DFU is an open wound on the foot, often occurring when bleeding develops beneath a callus and then the callus wears away. Deeper tissues of the foot are then exposed.

About half of the DFUs get infected, hence the FDA guidance, said Dr. Armstrong, who is also founding president of the American Limb Preservation Society, which aims to eliminate preventable amputations within the next generation. Every 20 seconds, Dr. Armstrong said, someone in the world loses a leg due to diabetes.
 

FDA Guidance on Drug Development for DFIs

In October, the FDA issued draft guidance for industry to articulate the design of clinical trials for developing antibacterial drugs to treat DFIs without concomitant bone and joint involvement. Comments closed on December 18. Among the points in the guidance, which is nonbinding, are to include DFIs of varying depths and extent in phase 3 trials and ideally to include only those patients who have not had prior antibacterial treatment for the current DFI.

According to an FDA spokesperson, “The agency is working to finalize the guidance. However, a timeline for its release has not yet been established.”

The good news about the upcoming FDA guidance, Dr. Armstrong said, is that the agency has realized the importance of treating the infections. Fully one third of direct costs of care for diabetes are spent on the lower extremities, he said. Keeping patients out of the hospital, uninfected, and “keeping legs on bodies” are all important goals, he said.

Pharmaceutical firms need to understand that “you aren’t dealing with a normal ulcer,” said Andrew J.M. Boulton, MD, professor of medicine at the University of Manchester and physician consultant at the Manchester Royal Infirmary, Manchester, England, and a visiting professor at the University of Miami. For research, “the most important thing is to take account of off-loading the ulcers,” he said. “Most ulcers will heal if put in a boot.”

Dr. Boulton, like Dr. Armstrong, a long-time expert in the field, contended that pharma has not understood this concept and has wasted millions over the last three decades doing studies that were poorly designed and controlled.
 

Treatments: Current, Under Study

Currently, DFIs are treated with antimicrobial therapy, without or without debridement, along with a clinical assessment for ischemia. If ischemia is found, care progresses to wound care and off-loading devices, such as healing sandals. Clinicians then assess the likelihood of improved outcomes with revascularization based on operative risks and distribution of lower extremity artery disease and proceed depending on the likelihood. If osteomyelitis testing shows it is present, providers proceed to wound debridement, limb-sparing amputation, and prolonged antimicrobials, as needed.

More options are needed, Dr. Armstrong said.

Among the many approaches under study:

• DFUs can be accurately detected by applying artificial intelligence to the “foot selfie” images taken by patients on smartphones, research by Dr.  and  has found.
• After a phase 3 study of  for DFUs originally intending to enroll 300 subjects was discontinued because of slow patient recruitment, an interim analysis was conducted on 44 participants. It showed a positive trend toward wound closure in the group receiving the injected gene therapy, VM202 (ENGENSIS), in their calf muscles. VM202 is a plasmid DNA-encoding human hepatocyte growth factor. While those in both the intervention and placebo groups showed wound-closing effects at month 6, in 23 patients with neuro-ischemic ulcers, the percentage of those reaching complete closure of the DFU was significantly higher in the treated group at months 3, 4, and 5 (P = .0391, .0391, and .0361, respectively). After excluding two outliers, the difference in months 3-6 became more significant (P = .03).
• An closed more DFUs than standard care after 12 weeks — 70% vs 34% (P = .00032). Of the 100 participants randomized, 50 per group, 42% of the treatment group and 56% of the control group experienced adverse events, with eight withdrawn due to serious adverse events (such as osteomyelitis).
• A closed more refractory DFUs over a 16-week study than standard sharp debridement, with 65% of water-treated ulcers healed but just 42% of the standard care group (P = .021, unadjusted).
• Researchers from UC Davis and VA Northern California Healthcare are evaluating timolol, a beta adrenergic receptor blocker already approved for topical administration for glaucoma, as a way to heal chronic DFUs faster. After demonstrating that the medication worked in animal models, researchers then launched a study to use it off-label for DFUs. While data are still being analyzed, researcher Roslyn (Rivkah) Isseroff, MD, of UC Davis and VA, said that data so far demonstrate that the timolol reduced transepidermal water loss in the healed wounds, and that is linked with a decrease in re-ulceration.

The Power of a Team

Multidisciplinary approaches to treatment are effective in reducing amputation, with one review of 33 studies finding the approach worked to decrease amputation in 94% of them. “The American Limb Preservation Society (ALPS) lists 30 programs,” said Dr. Armstrong, the founding president of the organization. “There may be as many as 100.”

Team compositions vary but usually include at least one medical specialty clinician, such as infectious disease, primary care, or endocrinology, and two or more specialty clinicians, such as vascular, podiatric, orthopedic, or plastic surgery. A shoe specialist is needed to prescribe and manage footwear. Other important team members include nutrition experts and behavioral health professionals to deal with associated depression.

Johns Hopkins’ Multidisciplinary Diabetic Foot and Wound Service launched in 2012 and includes vascular surgeons, surgical podiatrists, endocrinologists, wound care nurses, advanced practice staff, board-certified wound care specialists, orthopedic surgeons, infection disease experts, physical therapists, and certified orthotists.

“This interdisciplinary care model has been repeatedly validated by research as superior for limb salvage and wound healing,” said Nestoras Mathioudakis, MD, codirector of the service. “For instance, endocrinologists and diabetes educators are crucial for managing uncontrolled diabetes — a key factor in infection and delayed wound healing. Similarly, vascular surgeons play a vital role in addressing peripheral arterial disease to improve blood flow to the affected area.”

“Diabetic foot ulcers might require prolonged periods of specialized care, including meticulous wound management and off-loading, overseen by surgical podiatrists and wound care experts,” he said. “In cases where infection is present, particularly with multidrug resistant organisms or when standard antibiotics are contraindicated, the insight of an infectious disease specialist is invaluable.”

While the makeup of teams varies from location to location, he said “the hallmark of effective teams is their ability to comprehensively manage glycemic control, foot wounds, vascular disease, and infections.”

The power of teams, Dr. Armstrong said, is very much evident after his weekly “foot selfie rounds” conducted Mondays at 7 AM, with an “all feet on deck” approach. “Not a week goes by when we don’t stop a hospitalization,” he said of the team evaluating the photos, due to detecting issues early, while still in the manageable state.

Teams can trump technology, Dr. Armstrong said. A team of just a primary care doctor and a podiatrist can make a significant reduction in amputations, he said, just by a “Knock your socks off” approach. He reminds primary care doctors that observing the feet of their patients with diabetes can go a long way to reducing DFUs and the hospitalizations and amputations that can result.

Dr. Mathioudakis and Dr. Isseroff reported no disclosures. Dr. Boulton consults for Urgo Medical, Nevro Corporation, and AOT, Inc. Dr. Armstrong reported receiving consulting fees from Podimetrics; Molnlycke; Cardiovascular Systems, Inc.; Endo Pharmaceuticals; and Averitas Pharma (GRT US).

A version of this article first appeared on Medscape.com.

The photo of the patient’s foot, sent from his campsite, included a cheeky note: “I remember you telling me that getting in trouble doing something was better than getting in trouble doing nothing. This lets me get out there and know that I have feedback.”

The “this” was the patient’s “foot selfie,” an approach that allows patients at a risk for diabetic foot ulcers (DFUs) to snap a picture and send it to their healthcare providers for evaluation.

This particular patient had an extensive history of previous wounds. Some had essentially kept him house-bound in the past, as he was afraid to get another one.

This time, however, he got an all-clear to keep on camping, “and we scheduled him in on the following Tuesday [for follow-up],” said the camper’s physician David G. Armstrong, DPM, MD, PhD, professor of surgery and neurological surgery, USC Keck School of Medicine, Los Angeles.

Dr. Armstrong is one of the researchers evaluating the concept of foot selfies. It’s a welcome advance, he and others said, and has been shown to help heal wounds and reverse pre-ulcer lesions. Research on foot selfies continues, but much more is needed to solve the issue of DFUs, diabetic foot infections (DFIs), and the high rates of reinfection, experts know.

Worldwide, about 18.6 million people have a DFU each year, including 1.6 million in the United States. About 50%-60% of ulcers become infected, with 20% of moderate to severe infections requiring amputation of the limb. The 5-year mortality rate for DFUs is 30%, but it climbs to 70% after amputation. While about 40% of ulcers heal within 12 weeks, 42% recur at the 1-year mark, setting up a vicious and costly cycle. Healthcare costs for patients with diabetes and DFUs are five times as high as costs for patients with diabetes but no DFUs. The per capita cost to treat a DFU in America is $17,500.

While the statistics paint a grim picture, progress is being made on several fronts:

• US Food and Drug Administration (FDA) guidance on the development of drugs for DFUs, under evaluation, is forthcoming.
• New treatments are under study.
• A multidisciplinary team approach is known to improve outcomes.

Anatomy of a DFU

When neuropathy develops in those with diabetes, they no longer have what Dr. Armstrong calls the “gift” of pain perception. “They can wear a hole in their foot like you and I wear a hole in our sock or shoe,” he said. “That hole is called a diabetic foot ulcer.”

A DFU is an open wound on the foot, often occurring when bleeding develops beneath a callus and then the callus wears away. Deeper tissues of the foot are then exposed.

About half of the DFUs get infected, hence the FDA guidance, said Dr. Armstrong, who is also founding president of the American Limb Preservation Society, which aims to eliminate preventable amputations within the next generation. Every 20 seconds, Dr. Armstrong said, someone in the world loses a leg due to diabetes.
 

FDA Guidance on Drug Development for DFIs

In October, the FDA issued draft guidance for industry to articulate the design of clinical trials for developing antibacterial drugs to treat DFIs without concomitant bone and joint involvement. Comments closed on December 18. Among the points in the guidance, which is nonbinding, are to include DFIs of varying depths and extent in phase 3 trials and ideally to include only those patients who have not had prior antibacterial treatment for the current DFI.

According to an FDA spokesperson, “The agency is working to finalize the guidance. However, a timeline for its release has not yet been established.”

The good news about the upcoming FDA guidance, Dr. Armstrong said, is that the agency has realized the importance of treating the infections. Fully one third of direct costs of care for diabetes are spent on the lower extremities, he said. Keeping patients out of the hospital, uninfected, and “keeping legs on bodies” are all important goals, he said.

Pharmaceutical firms need to understand that “you aren’t dealing with a normal ulcer,” said Andrew J.M. Boulton, MD, professor of medicine at the University of Manchester and physician consultant at the Manchester Royal Infirmary, Manchester, England, and a visiting professor at the University of Miami. For research, “the most important thing is to take account of off-loading the ulcers,” he said. “Most ulcers will heal if put in a boot.”

Dr. Boulton, like Dr. Armstrong, a long-time expert in the field, contended that pharma has not understood this concept and has wasted millions over the last three decades doing studies that were poorly designed and controlled.
 

Treatments: Current, Under Study

Currently, DFIs are treated with antimicrobial therapy, without or without debridement, along with a clinical assessment for ischemia. If ischemia is found, care progresses to wound care and off-loading devices, such as healing sandals. Clinicians then assess the likelihood of improved outcomes with revascularization based on operative risks and distribution of lower extremity artery disease and proceed depending on the likelihood. If osteomyelitis testing shows it is present, providers proceed to wound debridement, limb-sparing amputation, and prolonged antimicrobials, as needed.

More options are needed, Dr. Armstrong said.

Among the many approaches under study:

• DFUs can be accurately detected by applying artificial intelligence to the “foot selfie” images taken by patients on smartphones, research by Dr.  and  has found.
• After a phase 3 study of  for DFUs originally intending to enroll 300 subjects was discontinued because of slow patient recruitment, an interim analysis was conducted on 44 participants. It showed a positive trend toward wound closure in the group receiving the injected gene therapy, VM202 (ENGENSIS), in their calf muscles. VM202 is a plasmid DNA-encoding human hepatocyte growth factor. While those in both the intervention and placebo groups showed wound-closing effects at month 6, in 23 patients with neuro-ischemic ulcers, the percentage of those reaching complete closure of the DFU was significantly higher in the treated group at months 3, 4, and 5 (P = .0391, .0391, and .0361, respectively). After excluding two outliers, the difference in months 3-6 became more significant (P = .03).
• An closed more DFUs than standard care after 12 weeks — 70% vs 34% (P = .00032). Of the 100 participants randomized, 50 per group, 42% of the treatment group and 56% of the control group experienced adverse events, with eight withdrawn due to serious adverse events (such as osteomyelitis).
• A closed more refractory DFUs over a 16-week study than standard sharp debridement, with 65% of water-treated ulcers healed but just 42% of the standard care group (P = .021, unadjusted).
• Researchers from UC Davis and VA Northern California Healthcare are evaluating timolol, a beta adrenergic receptor blocker already approved for topical administration for glaucoma, as a way to heal chronic DFUs faster. After demonstrating that the medication worked in animal models, researchers then launched a study to use it off-label for DFUs. While data are still being analyzed, researcher Roslyn (Rivkah) Isseroff, MD, of UC Davis and VA, said that data so far demonstrate that the timolol reduced transepidermal water loss in the healed wounds, and that is linked with a decrease in re-ulceration.

The Power of a Team

Multidisciplinary approaches to treatment are effective in reducing amputation, with one review of 33 studies finding the approach worked to decrease amputation in 94% of them. “The American Limb Preservation Society (ALPS) lists 30 programs,” said Dr. Armstrong, the founding president of the organization. “There may be as many as 100.”

Team compositions vary but usually include at least one medical specialty clinician, such as infectious disease, primary care, or endocrinology, and two or more specialty clinicians, such as vascular, podiatric, orthopedic, or plastic surgery. A shoe specialist is needed to prescribe and manage footwear. Other important team members include nutrition experts and behavioral health professionals to deal with associated depression.

Johns Hopkins’ Multidisciplinary Diabetic Foot and Wound Service launched in 2012 and includes vascular surgeons, surgical podiatrists, endocrinologists, wound care nurses, advanced practice staff, board-certified wound care specialists, orthopedic surgeons, infection disease experts, physical therapists, and certified orthotists.

“This interdisciplinary care model has been repeatedly validated by research as superior for limb salvage and wound healing,” said Nestoras Mathioudakis, MD, codirector of the service. “For instance, endocrinologists and diabetes educators are crucial for managing uncontrolled diabetes — a key factor in infection and delayed wound healing. Similarly, vascular surgeons play a vital role in addressing peripheral arterial disease to improve blood flow to the affected area.”

“Diabetic foot ulcers might require prolonged periods of specialized care, including meticulous wound management and off-loading, overseen by surgical podiatrists and wound care experts,” he said. “In cases where infection is present, particularly with multidrug resistant organisms or when standard antibiotics are contraindicated, the insight of an infectious disease specialist is invaluable.”

While the makeup of teams varies from location to location, he said “the hallmark of effective teams is their ability to comprehensively manage glycemic control, foot wounds, vascular disease, and infections.”

The power of teams, Dr. Armstrong said, is very much evident after his weekly “foot selfie rounds” conducted Mondays at 7 AM, with an “all feet on deck” approach. “Not a week goes by when we don’t stop a hospitalization,” he said of the team evaluating the photos, due to detecting issues early, while still in the manageable state.

Teams can trump technology, Dr. Armstrong said. A team of just a primary care doctor and a podiatrist can make a significant reduction in amputations, he said, just by a “Knock your socks off” approach. He reminds primary care doctors that observing the feet of their patients with diabetes can go a long way to reducing DFUs and the hospitalizations and amputations that can result.

Dr. Mathioudakis and Dr. Isseroff reported no disclosures. Dr. Boulton consults for Urgo Medical, Nevro Corporation, and AOT, Inc. Dr. Armstrong reported receiving consulting fees from Podimetrics; Molnlycke; Cardiovascular Systems, Inc.; Endo Pharmaceuticals; and Averitas Pharma (GRT US).

A version of this article first appeared on Medscape.com.

The photo of the patient’s foot, sent from his campsite, included a cheeky note: “I remember you telling me that getting in trouble doing something was better than getting in trouble doing nothing. This lets me get out there and know that I have feedback.”

The “this” was the patient’s “foot selfie,” an approach that allows patients at a risk for diabetic foot ulcers (DFUs) to snap a picture and send it to their healthcare providers for evaluation.

This particular patient had an extensive history of previous wounds. Some had essentially kept him house-bound in the past, as he was afraid to get another one.

This time, however, he got an all-clear to keep on camping, “and we scheduled him in on the following Tuesday [for follow-up],” said the camper’s physician David G. Armstrong, DPM, MD, PhD, professor of surgery and neurological surgery, USC Keck School of Medicine, Los Angeles.

Dr. Armstrong is one of the researchers evaluating the concept of foot selfies. It’s a welcome advance, he and others said, and has been shown to help heal wounds and reverse pre-ulcer lesions. Research on foot selfies continues, but much more is needed to solve the issue of DFUs, diabetic foot infections (DFIs), and the high rates of reinfection, experts know.

Worldwide, about 18.6 million people have a DFU each year, including 1.6 million in the United States. About 50%-60% of ulcers become infected, with 20% of moderate to severe infections requiring amputation of the limb. The 5-year mortality rate for DFUs is 30%, but it climbs to 70% after amputation. While about 40% of ulcers heal within 12 weeks, 42% recur at the 1-year mark, setting up a vicious and costly cycle. Healthcare costs for patients with diabetes and DFUs are five times as high as costs for patients with diabetes but no DFUs. The per capita cost to treat a DFU in America is $17,500.

While the statistics paint a grim picture, progress is being made on several fronts:

• US Food and Drug Administration (FDA) guidance on the development of drugs for DFUs, under evaluation, is forthcoming.
• New treatments are under study.
• A multidisciplinary team approach is known to improve outcomes.

Anatomy of a DFU

When neuropathy develops in those with diabetes, they no longer have what Dr. Armstrong calls the “gift” of pain perception. “They can wear a hole in their foot like you and I wear a hole in our sock or shoe,” he said. “That hole is called a diabetic foot ulcer.”

A DFU is an open wound on the foot, often occurring when bleeding develops beneath a callus and then the callus wears away. Deeper tissues of the foot are then exposed.

About half of the DFUs get infected, hence the FDA guidance, said Dr. Armstrong, who is also founding president of the American Limb Preservation Society, which aims to eliminate preventable amputations within the next generation. Every 20 seconds, Dr. Armstrong said, someone in the world loses a leg due to diabetes.
 

FDA Guidance on Drug Development for DFIs

In October, the FDA issued draft guidance for industry to articulate the design of clinical trials for developing antibacterial drugs to treat DFIs without concomitant bone and joint involvement. Comments closed on December 18. Among the points in the guidance, which is nonbinding, are to include DFIs of varying depths and extent in phase 3 trials and ideally to include only those patients who have not had prior antibacterial treatment for the current DFI.

According to an FDA spokesperson, “The agency is working to finalize the guidance. However, a timeline for its release has not yet been established.”

The good news about the upcoming FDA guidance, Dr. Armstrong said, is that the agency has realized the importance of treating the infections. Fully one third of direct costs of care for diabetes are spent on the lower extremities, he said. Keeping patients out of the hospital, uninfected, and “keeping legs on bodies” are all important goals, he said.

Pharmaceutical firms need to understand that “you aren’t dealing with a normal ulcer,” said Andrew J.M. Boulton, MD, professor of medicine at the University of Manchester and physician consultant at the Manchester Royal Infirmary, Manchester, England, and a visiting professor at the University of Miami. For research, “the most important thing is to take account of off-loading the ulcers,” he said. “Most ulcers will heal if put in a boot.”

Dr. Boulton, like Dr. Armstrong, a long-time expert in the field, contended that pharma has not understood this concept and has wasted millions over the last three decades doing studies that were poorly designed and controlled.
 

Treatments: Current, Under Study

Currently, DFIs are treated with antimicrobial therapy, without or without debridement, along with a clinical assessment for ischemia. If ischemia is found, care progresses to wound care and off-loading devices, such as healing sandals. Clinicians then assess the likelihood of improved outcomes with revascularization based on operative risks and distribution of lower extremity artery disease and proceed depending on the likelihood. If osteomyelitis testing shows it is present, providers proceed to wound debridement, limb-sparing amputation, and prolonged antimicrobials, as needed.

More options are needed, Dr. Armstrong said.

Among the many approaches under study:

• DFUs can be accurately detected by applying artificial intelligence to the “foot selfie” images taken by patients on smartphones, research by Dr.  and  has found.
• After a phase 3 study of  for DFUs originally intending to enroll 300 subjects was discontinued because of slow patient recruitment, an interim analysis was conducted on 44 participants. It showed a positive trend toward wound closure in the group receiving the injected gene therapy, VM202 (ENGENSIS), in their calf muscles. VM202 is a plasmid DNA-encoding human hepatocyte growth factor. While those in both the intervention and placebo groups showed wound-closing effects at month 6, in 23 patients with neuro-ischemic ulcers, the percentage of those reaching complete closure of the DFU was significantly higher in the treated group at months 3, 4, and 5 (P = .0391, .0391, and .0361, respectively). After excluding two outliers, the difference in months 3-6 became more significant (P = .03).
• An closed more DFUs than standard care after 12 weeks — 70% vs 34% (P = .00032). Of the 100 participants randomized, 50 per group, 42% of the treatment group and 56% of the control group experienced adverse events, with eight withdrawn due to serious adverse events (such as osteomyelitis).
• A closed more refractory DFUs over a 16-week study than standard sharp debridement, with 65% of water-treated ulcers healed but just 42% of the standard care group (P = .021, unadjusted).
• Researchers from UC Davis and VA Northern California Healthcare are evaluating timolol, a beta adrenergic receptor blocker already approved for topical administration for glaucoma, as a way to heal chronic DFUs faster. After demonstrating that the medication worked in animal models, researchers then launched a study to use it off-label for DFUs. While data are still being analyzed, researcher Roslyn (Rivkah) Isseroff, MD, of UC Davis and VA, said that data so far demonstrate that the timolol reduced transepidermal water loss in the healed wounds, and that is linked with a decrease in re-ulceration.

The Power of a Team

Multidisciplinary approaches to treatment are effective in reducing amputation, with one review of 33 studies finding the approach worked to decrease amputation in 94% of them. “The American Limb Preservation Society (ALPS) lists 30 programs,” said Dr. Armstrong, the founding president of the organization. “There may be as many as 100.”

Team compositions vary but usually include at least one medical specialty clinician, such as infectious disease, primary care, or endocrinology, and two or more specialty clinicians, such as vascular, podiatric, orthopedic, or plastic surgery. A shoe specialist is needed to prescribe and manage footwear. Other important team members include nutrition experts and behavioral health professionals to deal with associated depression.

Johns Hopkins’ Multidisciplinary Diabetic Foot and Wound Service launched in 2012 and includes vascular surgeons, surgical podiatrists, endocrinologists, wound care nurses, advanced practice staff, board-certified wound care specialists, orthopedic surgeons, infection disease experts, physical therapists, and certified orthotists.

“This interdisciplinary care model has been repeatedly validated by research as superior for limb salvage and wound healing,” said Nestoras Mathioudakis, MD, codirector of the service. “For instance, endocrinologists and diabetes educators are crucial for managing uncontrolled diabetes — a key factor in infection and delayed wound healing. Similarly, vascular surgeons play a vital role in addressing peripheral arterial disease to improve blood flow to the affected area.”

“Diabetic foot ulcers might require prolonged periods of specialized care, including meticulous wound management and off-loading, overseen by surgical podiatrists and wound care experts,” he said. “In cases where infection is present, particularly with multidrug resistant organisms or when standard antibiotics are contraindicated, the insight of an infectious disease specialist is invaluable.”

While the makeup of teams varies from location to location, he said “the hallmark of effective teams is their ability to comprehensively manage glycemic control, foot wounds, vascular disease, and infections.”

The power of teams, Dr. Armstrong said, is very much evident after his weekly “foot selfie rounds” conducted Mondays at 7 AM, with an “all feet on deck” approach. “Not a week goes by when we don’t stop a hospitalization,” he said of the team evaluating the photos, due to detecting issues early, while still in the manageable state.

Teams can trump technology, Dr. Armstrong said. A team of just a primary care doctor and a podiatrist can make a significant reduction in amputations, he said, just by a “Knock your socks off” approach. He reminds primary care doctors that observing the feet of their patients with diabetes can go a long way to reducing DFUs and the hospitalizations and amputations that can result.

Dr. Mathioudakis and Dr. Isseroff reported no disclosures. Dr. Boulton consults for Urgo Medical, Nevro Corporation, and AOT, Inc. Dr. Armstrong reported receiving consulting fees from Podimetrics; Molnlycke; Cardiovascular Systems, Inc.; Endo Pharmaceuticals; and Averitas Pharma (GRT US).

A version of this article first appeared on Medscape.com.

TOPLINE:

Less than 7 hours of sleep per night is common in individuals with type 1 diabetes (T1D) but is tied to poor cardiometabolic health, particularly in adolescents.

METHODOLOGY:

• Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
• This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
• Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
• They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
• Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.

TAKEAWAY:

• Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
• Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
• When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
• Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.

IN PRACTICE:

“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.

SOURCE:

Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.

DISCLOSURES:

This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.

A version of this article appeared on Medscape.com.

TOPLINE:

Less than 7 hours of sleep per night is common in individuals with type 1 diabetes (T1D) but is tied to poor cardiometabolic health, particularly in adolescents.

METHODOLOGY:

• Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
• This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
• Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
• They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
• Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.

TAKEAWAY:

• Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
• Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
• When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
• Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.

IN PRACTICE:

“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.

SOURCE:

Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.

DISCLOSURES:

This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.

A version of this article appeared on Medscape.com.

TOPLINE:

Less than 7 hours of sleep per night is common in individuals with type 1 diabetes (T1D) but is tied to poor cardiometabolic health, particularly in adolescents.

METHODOLOGY:

• Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
• This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
• Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
• They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
• Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.

TAKEAWAY:

• Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
• Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
• When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
• Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.

IN PRACTICE:

“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.

SOURCE:

Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.

DISCLOSURES:

This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.

A version of this article appeared on Medscape.com.

TOPLINE:

A low-fat vegan diet — high in fiber and carbohydrates and moderate in protein — reduces insulin requirement, increases insulin sensitivity, and improves glycemic control in individuals with type 1 diabetes (T1D) compared with a conventional portion-controlled diet.

METHODOLOGY:

• The effects of a low-fat vegan diet (without carbohydrate or portion restriction) were compared with those of a conventional portion-controlled, carbohydrate-controlled diet in 58 patients with T1D (age, ≥ 18 years) who had been receiving stable insulin treatment for the past 3 months.
• Participants were randomly assigned to receive either the vegan diet (n = 29), comprising vegetables, grains, legumes, and fruits, or the portion-controlled diet (n = 29), which reduced daily energy intake by 500-1000 kcal/d in participants with overweight while maintaining a stable carbohydrate intake.
• The primary clinical outcomes were insulin requirement (total daily dose of insulin), insulin sensitivity, and glycemic control (A1c).
• Other assessments included the blood, lipid profile, blood urea nitrogen, blood urea nitrogen-to-creatinine ratio, and body weight.

TAKEAWAY:

• The study was completed by 18 participants in the vegan-diet group and 17 in the portion-controlled group.
• In the vegan group, the total daily dose of insulin decreased by 12.1 units/d (P = .007) and insulin sensitivity increased by 6.6 g of carbohydrate per unit of insulin on average (P = .002), with no significant changes in the portion-controlled diet group.
• Participants on the vegan diet had lower levels of total and low-density lipoprotein cholesterol and blood urea nitrogen and a lower blood urea nitrogen-to-creatinine ratio (P for all < .001), whereas both vegan and portion-controlled groups had lower A1c levels.
• Body weight decreased by 5.2 kg (P < .001) in the vegan group; there were no significant changes in the portion-controlled group.
• For every 1-kg weight loss, there was a 2.16-unit decrease in the insulin total daily dose and a 0.9-unit increase in insulin sensitivity.

IN PRACTICE:

“This study provides substantial support for a low-fat vegan diet that is high in fiber and carbohydrates, low in fat, and moderate in protein” and suggests the potential therapeutic use of this diet in type 1 diabetes management, the authors wrote.

SOURCE:

The study led by Hana Kahleova, MD, PhD, Physicians Committee for Responsible Medicine, Washington, was published in Clinical Diabetes.

LIMITATIONS:

Dietary intake was recorded on the basis of self-reported data. A higher attrition rate was observed due to meal and blood glucose monitoring. The findings may have limited generalizability as the study participants comprised those seeking help for T1D.

DISCLOSURES:

The study was supported by the Physicians Committee for Responsible Medicine and a grant from the Institute for Technology in Healthcare. Some authors reported receiving compensation, being cofounders of a coaching program, writing books, providing nutrition coaching, giving lectures, or receiving royalties and honoraria from various sources.

A version of this article appeared on Medscape.com.

TOPLINE:

A low-fat vegan diet — high in fiber and carbohydrates and moderate in protein — reduces insulin requirement, increases insulin sensitivity, and improves glycemic control in individuals with type 1 diabetes (T1D) compared with a conventional portion-controlled diet.

METHODOLOGY:

• The effects of a low-fat vegan diet (without carbohydrate or portion restriction) were compared with those of a conventional portion-controlled, carbohydrate-controlled diet in 58 patients with T1D (age, ≥ 18 years) who had been receiving stable insulin treatment for the past 3 months.
• Participants were randomly assigned to receive either the vegan diet (n = 29), comprising vegetables, grains, legumes, and fruits, or the portion-controlled diet (n = 29), which reduced daily energy intake by 500-1000 kcal/d in participants with overweight while maintaining a stable carbohydrate intake.
• The primary clinical outcomes were insulin requirement (total daily dose of insulin), insulin sensitivity, and glycemic control (A1c).
• Other assessments included the blood, lipid profile, blood urea nitrogen, blood urea nitrogen-to-creatinine ratio, and body weight.

TAKEAWAY:

• The study was completed by 18 participants in the vegan-diet group and 17 in the portion-controlled group.
• In the vegan group, the total daily dose of insulin decreased by 12.1 units/d (P = .007) and insulin sensitivity increased by 6.6 g of carbohydrate per unit of insulin on average (P = .002), with no significant changes in the portion-controlled diet group.
• Participants on the vegan diet had lower levels of total and low-density lipoprotein cholesterol and blood urea nitrogen and a lower blood urea nitrogen-to-creatinine ratio (P for all < .001), whereas both vegan and portion-controlled groups had lower A1c levels.
• Body weight decreased by 5.2 kg (P < .001) in the vegan group; there were no significant changes in the portion-controlled group.
• For every 1-kg weight loss, there was a 2.16-unit decrease in the insulin total daily dose and a 0.9-unit increase in insulin sensitivity.

IN PRACTICE:

“This study provides substantial support for a low-fat vegan diet that is high in fiber and carbohydrates, low in fat, and moderate in protein” and suggests the potential therapeutic use of this diet in type 1 diabetes management, the authors wrote.

SOURCE:

The study led by Hana Kahleova, MD, PhD, Physicians Committee for Responsible Medicine, Washington, was published in Clinical Diabetes.

LIMITATIONS:

Dietary intake was recorded on the basis of self-reported data. A higher attrition rate was observed due to meal and blood glucose monitoring. The findings may have limited generalizability as the study participants comprised those seeking help for T1D.

DISCLOSURES:

The study was supported by the Physicians Committee for Responsible Medicine and a grant from the Institute for Technology in Healthcare. Some authors reported receiving compensation, being cofounders of a coaching program, writing books, providing nutrition coaching, giving lectures, or receiving royalties and honoraria from various sources.

A version of this article appeared on Medscape.com.

TOPLINE:

A low-fat vegan diet — high in fiber and carbohydrates and moderate in protein — reduces insulin requirement, increases insulin sensitivity, and improves glycemic control in individuals with type 1 diabetes (T1D) compared with a conventional portion-controlled diet.

METHODOLOGY:

• The effects of a low-fat vegan diet (without carbohydrate or portion restriction) were compared with those of a conventional portion-controlled, carbohydrate-controlled diet in 58 patients with T1D (age, ≥ 18 years) who had been receiving stable insulin treatment for the past 3 months.
• Participants were randomly assigned to receive either the vegan diet (n = 29), comprising vegetables, grains, legumes, and fruits, or the portion-controlled diet (n = 29), which reduced daily energy intake by 500-1000 kcal/d in participants with overweight while maintaining a stable carbohydrate intake.
• The primary clinical outcomes were insulin requirement (total daily dose of insulin), insulin sensitivity, and glycemic control (A1c).
• Other assessments included the blood, lipid profile, blood urea nitrogen, blood urea nitrogen-to-creatinine ratio, and body weight.

TAKEAWAY:

• The study was completed by 18 participants in the vegan-diet group and 17 in the portion-controlled group.
• In the vegan group, the total daily dose of insulin decreased by 12.1 units/d (P = .007) and insulin sensitivity increased by 6.6 g of carbohydrate per unit of insulin on average (P = .002), with no significant changes in the portion-controlled diet group.
• Participants on the vegan diet had lower levels of total and low-density lipoprotein cholesterol and blood urea nitrogen and a lower blood urea nitrogen-to-creatinine ratio (P for all < .001), whereas both vegan and portion-controlled groups had lower A1c levels.
• Body weight decreased by 5.2 kg (P < .001) in the vegan group; there were no significant changes in the portion-controlled group.
• For every 1-kg weight loss, there was a 2.16-unit decrease in the insulin total daily dose and a 0.9-unit increase in insulin sensitivity.

IN PRACTICE:

“This study provides substantial support for a low-fat vegan diet that is high in fiber and carbohydrates, low in fat, and moderate in protein” and suggests the potential therapeutic use of this diet in type 1 diabetes management, the authors wrote.

SOURCE:

The study led by Hana Kahleova, MD, PhD, Physicians Committee for Responsible Medicine, Washington, was published in Clinical Diabetes.

LIMITATIONS:

Dietary intake was recorded on the basis of self-reported data. A higher attrition rate was observed due to meal and blood glucose monitoring. The findings may have limited generalizability as the study participants comprised those seeking help for T1D.

DISCLOSURES:

The study was supported by the Physicians Committee for Responsible Medicine and a grant from the Institute for Technology in Healthcare. Some authors reported receiving compensation, being cofounders of a coaching program, writing books, providing nutrition coaching, giving lectures, or receiving royalties and honoraria from various sources.

A version of this article appeared on Medscape.com.

DENVER — Unlike traditional antidiabetic therapies, which have never been associated with a significant reduction in stroke in a major trial, some of the newer drugs are showing that benefit, but the protection is not linked to tighter glycemic control.

In patients with type 2 diabetes mellitus (T2DM), the evidence is strong that “they are not working through glycemic control per se,” according to Larry B. Goldstein, MD, chair of neurology, University of Kentucky School of Medicine, Louisville. “But it is not yet clear what the mechanism of benefit is.”

Ted Bosworth/MDedge News

Stroke Prevention With Antidiabetic Drugs

“What has changed is that we have new ways of glycemic control, and some of these do show protection against stroke,” Dr. Goldstein said. Yet, the newer drugs do not do a better job at sustained reductions of HbA1c or other measures of reaching lower blood glucose reductions when adherence is similar.

“The level of glucose control with the newer agents is really about the same,” Dr. Goldstein said at the annual meeting of the American Academy of Neurology, where he led a symposium called Controversies in Stroke Treatment and Prevention.

The newer agents, such as sodium glucose co-transport-2 inhibitors (SGLT-2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA), have been associated with significant and clinically meaningful reductions in cardiovascular events. However, it is not clear that even these two medications perform similarly for stroke prevention specifically.

Of these two drug classes, Dr. Goldstein said the evidence most strongly supports GLP-1 receptor agonists. He cited one meta-analysis of eight randomized studies that calculated a risk reduction of about 15% whether calculated for fatal or nonfatal strokes. For each the protection was highly statistically significant (P = .0002 and P < .001, respectively).

In contrast, the effect of SGLT-2 inhibitors is weaker. In a study that distilled data from large cardiovascular trials with GLP-1RA, SGLT2i, dipeptidyl peptidase-4 inhibitors (DPP4i), and pioglitazone, a thiazolidinedione, only GLP-1RA drugs were associated with a highly significant (P < .001) reduction in risk of stroke. The risk reduction for pioglitazone reached significance (P = .025), but there was no signal of risk reduction for SGLT2i (P = .88) or for DPP4i (P = .5).
 

Weight Loss Is Potential Mechanism

Looking to explain the protection from stroke associated with some of the newer antidiabetic therapies, Gordon Kelley, MD, who leads the stroke program for AdventHealth Medical Group, Shawnee Mission, Kansas, suggested that weight loss is probably important.

“In our group, we work as a team to manage stroke risk in patients with diabetes, so I am not much involved in the choice of antidiabetic therapies, but it does seem that SGLT2 inhibitors and the GLP-1 receptor agonists share weight loss as an effect beyond glucose control,” he said.

Dr. Goldstein agreed that weight loss is a potential contributor to the cardiovascular benefits of GLP-1RA and SGLT2i, but he indicated that it might not help explain the reduction in stroke, an effect demonstrated repeatedly with GLP-1RA but inconsistently with SGLT2i.

The argument against weight loss as the critical mechanism of stroke prevention from newer antidiabetic drugs is strengthened by studies that suggest weight loss with SGLT2i appears to be even better than on GLP-1RA. In a study published in a pharmacy journal, weight loss was about twice as great among T2DM patients after 6 months of treatment managed with SGLT2i relative to those on a GLP-1RA (-2.8 vs 1.15 kg; P = .014).
 

Newer Antidiabetic Agents Guideline Recommended

In the 2019 American College of Cardiology/American Heart Association guidelines on the Primary Prevention of Cardiovascular Disease, stroke reduction is not discussed as an isolated risk, but these guidelines do recommend GLP-1RA or SGLT2i after metformin for glycemic control in T2DM patients with atherosclerotic cardiovascular disease (ASCVD) risk factors. This is based on evidence that drugs of both classes reduce risk for ASCVD events. The risk reduction has been particularly strong for heart failure.

For the risk of stroke specifically in patients with T2DM, Dr. Goldstein recommended calculating the ASCVD risk with the simple but well validated ACC risk calculator that is available online and is quickly completed when values for patient risk factors are readily available. For those with greater than 10% risk of an event in the next 10 years, he thinks GLP-1RA are a reasonable choice for prevention of stroke and other ASCVD events.

“GLP-1RA is mentioned in the guidelines, so this is supported,” said Dr. Goldstein, although adding that his choice of this class over SGLT2i is a personal if informed recommendation. He believes that the data favor GLP-1RA even if the exact mechanism of this protection is yet to be identified.

Dr. Goldstein and Dr. Kelley report no potential conflicts of interest.

DENVER — Unlike traditional antidiabetic therapies, which have never been associated with a significant reduction in stroke in a major trial, some of the newer drugs are showing that benefit, but the protection is not linked to tighter glycemic control.

In patients with type 2 diabetes mellitus (T2DM), the evidence is strong that “they are not working through glycemic control per se,” according to Larry B. Goldstein, MD, chair of neurology, University of Kentucky School of Medicine, Louisville. “But it is not yet clear what the mechanism of benefit is.”

Ted Bosworth/MDedge News

Stroke Prevention With Antidiabetic Drugs

“What has changed is that we have new ways of glycemic control, and some of these do show protection against stroke,” Dr. Goldstein said. Yet, the newer drugs do not do a better job at sustained reductions of HbA1c or other measures of reaching lower blood glucose reductions when adherence is similar.

“The level of glucose control with the newer agents is really about the same,” Dr. Goldstein said at the annual meeting of the American Academy of Neurology, where he led a symposium called Controversies in Stroke Treatment and Prevention.

The newer agents, such as sodium glucose co-transport-2 inhibitors (SGLT-2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA), have been associated with significant and clinically meaningful reductions in cardiovascular events. However, it is not clear that even these two medications perform similarly for stroke prevention specifically.

Of these two drug classes, Dr. Goldstein said the evidence most strongly supports GLP-1 receptor agonists. He cited one meta-analysis of eight randomized studies that calculated a risk reduction of about 15% whether calculated for fatal or nonfatal strokes. For each the protection was highly statistically significant (P = .0002 and P < .001, respectively).

In contrast, the effect of SGLT-2 inhibitors is weaker. In a study that distilled data from large cardiovascular trials with GLP-1RA, SGLT2i, dipeptidyl peptidase-4 inhibitors (DPP4i), and pioglitazone, a thiazolidinedione, only GLP-1RA drugs were associated with a highly significant (P < .001) reduction in risk of stroke. The risk reduction for pioglitazone reached significance (P = .025), but there was no signal of risk reduction for SGLT2i (P = .88) or for DPP4i (P = .5).
 

Weight Loss Is Potential Mechanism

Looking to explain the protection from stroke associated with some of the newer antidiabetic therapies, Gordon Kelley, MD, who leads the stroke program for AdventHealth Medical Group, Shawnee Mission, Kansas, suggested that weight loss is probably important.

“In our group, we work as a team to manage stroke risk in patients with diabetes, so I am not much involved in the choice of antidiabetic therapies, but it does seem that SGLT2 inhibitors and the GLP-1 receptor agonists share weight loss as an effect beyond glucose control,” he said.

Dr. Goldstein agreed that weight loss is a potential contributor to the cardiovascular benefits of GLP-1RA and SGLT2i, but he indicated that it might not help explain the reduction in stroke, an effect demonstrated repeatedly with GLP-1RA but inconsistently with SGLT2i.

The argument against weight loss as the critical mechanism of stroke prevention from newer antidiabetic drugs is strengthened by studies that suggest weight loss with SGLT2i appears to be even better than on GLP-1RA. In a study published in a pharmacy journal, weight loss was about twice as great among T2DM patients after 6 months of treatment managed with SGLT2i relative to those on a GLP-1RA (-2.8 vs 1.15 kg; P = .014).
 

Newer Antidiabetic Agents Guideline Recommended

In the 2019 American College of Cardiology/American Heart Association guidelines on the Primary Prevention of Cardiovascular Disease, stroke reduction is not discussed as an isolated risk, but these guidelines do recommend GLP-1RA or SGLT2i after metformin for glycemic control in T2DM patients with atherosclerotic cardiovascular disease (ASCVD) risk factors. This is based on evidence that drugs of both classes reduce risk for ASCVD events. The risk reduction has been particularly strong for heart failure.

For the risk of stroke specifically in patients with T2DM, Dr. Goldstein recommended calculating the ASCVD risk with the simple but well validated ACC risk calculator that is available online and is quickly completed when values for patient risk factors are readily available. For those with greater than 10% risk of an event in the next 10 years, he thinks GLP-1RA are a reasonable choice for prevention of stroke and other ASCVD events.

“GLP-1RA is mentioned in the guidelines, so this is supported,” said Dr. Goldstein, although adding that his choice of this class over SGLT2i is a personal if informed recommendation. He believes that the data favor GLP-1RA even if the exact mechanism of this protection is yet to be identified.

Dr. Goldstein and Dr. Kelley report no potential conflicts of interest.

DENVER — Unlike traditional antidiabetic therapies, which have never been associated with a significant reduction in stroke in a major trial, some of the newer drugs are showing that benefit, but the protection is not linked to tighter glycemic control.

In patients with type 2 diabetes mellitus (T2DM), the evidence is strong that “they are not working through glycemic control per se,” according to Larry B. Goldstein, MD, chair of neurology, University of Kentucky School of Medicine, Louisville. “But it is not yet clear what the mechanism of benefit is.”

Ted Bosworth/MDedge News

Stroke Prevention With Antidiabetic Drugs

“What has changed is that we have new ways of glycemic control, and some of these do show protection against stroke,” Dr. Goldstein said. Yet, the newer drugs do not do a better job at sustained reductions of HbA1c or other measures of reaching lower blood glucose reductions when adherence is similar.

“The level of glucose control with the newer agents is really about the same,” Dr. Goldstein said at the annual meeting of the American Academy of Neurology, where he led a symposium called Controversies in Stroke Treatment and Prevention.

The newer agents, such as sodium glucose co-transport-2 inhibitors (SGLT-2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA), have been associated with significant and clinically meaningful reductions in cardiovascular events. However, it is not clear that even these two medications perform similarly for stroke prevention specifically.

Of these two drug classes, Dr. Goldstein said the evidence most strongly supports GLP-1 receptor agonists. He cited one meta-analysis of eight randomized studies that calculated a risk reduction of about 15% whether calculated for fatal or nonfatal strokes. For each the protection was highly statistically significant (P = .0002 and P < .001, respectively).

In contrast, the effect of SGLT-2 inhibitors is weaker. In a study that distilled data from large cardiovascular trials with GLP-1RA, SGLT2i, dipeptidyl peptidase-4 inhibitors (DPP4i), and pioglitazone, a thiazolidinedione, only GLP-1RA drugs were associated with a highly significant (P < .001) reduction in risk of stroke. The risk reduction for pioglitazone reached significance (P = .025), but there was no signal of risk reduction for SGLT2i (P = .88) or for DPP4i (P = .5).
 

Weight Loss Is Potential Mechanism

Looking to explain the protection from stroke associated with some of the newer antidiabetic therapies, Gordon Kelley, MD, who leads the stroke program for AdventHealth Medical Group, Shawnee Mission, Kansas, suggested that weight loss is probably important.

“In our group, we work as a team to manage stroke risk in patients with diabetes, so I am not much involved in the choice of antidiabetic therapies, but it does seem that SGLT2 inhibitors and the GLP-1 receptor agonists share weight loss as an effect beyond glucose control,” he said.

Dr. Goldstein agreed that weight loss is a potential contributor to the cardiovascular benefits of GLP-1RA and SGLT2i, but he indicated that it might not help explain the reduction in stroke, an effect demonstrated repeatedly with GLP-1RA but inconsistently with SGLT2i.

The argument against weight loss as the critical mechanism of stroke prevention from newer antidiabetic drugs is strengthened by studies that suggest weight loss with SGLT2i appears to be even better than on GLP-1RA. In a study published in a pharmacy journal, weight loss was about twice as great among T2DM patients after 6 months of treatment managed with SGLT2i relative to those on a GLP-1RA (-2.8 vs 1.15 kg; P = .014).
 

Newer Antidiabetic Agents Guideline Recommended

In the 2019 American College of Cardiology/American Heart Association guidelines on the Primary Prevention of Cardiovascular Disease, stroke reduction is not discussed as an isolated risk, but these guidelines do recommend GLP-1RA or SGLT2i after metformin for glycemic control in T2DM patients with atherosclerotic cardiovascular disease (ASCVD) risk factors. This is based on evidence that drugs of both classes reduce risk for ASCVD events. The risk reduction has been particularly strong for heart failure.

For the risk of stroke specifically in patients with T2DM, Dr. Goldstein recommended calculating the ASCVD risk with the simple but well validated ACC risk calculator that is available online and is quickly completed when values for patient risk factors are readily available. For those with greater than 10% risk of an event in the next 10 years, he thinks GLP-1RA are a reasonable choice for prevention of stroke and other ASCVD events.

“GLP-1RA is mentioned in the guidelines, so this is supported,” said Dr. Goldstein, although adding that his choice of this class over SGLT2i is a personal if informed recommendation. He believes that the data favor GLP-1RA even if the exact mechanism of this protection is yet to be identified.

Dr. Goldstein and Dr. Kelley report no potential conflicts of interest.