Obesity

MADRID — Amycretin, a dual-pathway, oral weight loss drug, led to up to 13% body weight loss in participants with overweight or obesity according to phase 1, first-in-human study data presented at the European Association for the Study of Diabetes (EASD) 2024 annual meeting.

Body weight loss was “remarkable for an orally delivered biologic,” said Agnes Gasiorek, PhD, senior clinical pharmacology specialist at Novo Nordisk, Måløv, Denmark, who presented the results. And “there was no plateauing of weight loss in the treatment period.”

The mean change in percentage body weight was –10.4% with amycretin 50 mg, –13.1% with amycretin 2 × 50 mg, and –1.2% with placebo after 12 weeks of treatment.

With respect to the primary endpoint, stepwise dose escalation demonstrated that all tested dose levels up to and including 2 × 50 mg over a 12-week escalation period were safe and tolerable, Dr. Gasiorek reported.

The adverse events were in line with what was expected from targeting these receptors, and no new safety signals appeared during the study, she added.
 

Dual Pathways

Amycretin is a novel protein-based unimolecular amylin combined with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) and is the first oral formulation of this combination under development.

The two components are both known to reduce appetite and energy intake and increase satiety, said Dr. Gasiorek, but amylin is considered to potentially increase leptin sensitivity and GLP-1 RAs are known to increase insulin secretion and biosynthesis. Together, the two components improve insulin sensitivity, decrease glucagon secretion, and lead to acute delay in gastric emptying.

The single-center, placebo-controlled, double-blind phase 1 study enrolled men and women aged 18-55 years (mean, 38-42 years across groups) with a body mass index of 25.0-39.9, without diabetes, and considered otherwise healthy. 

Participants were randomly assigned to receive to receive oral amycretin (n = 95) or placebo (n = 29) once a day for up to 12 weeks. Study arms comprised single-ascending dosing (increasing from 1 mg/d to 25 mg), and multiple-ascending dosing. The latter consisted of multiple ascending doses (from 3 to 12 mg) over 10 days and multiple ascending doses (stepwise dose escalation, from 3 mg up to a final dose of 2 × 50 mg) over 12 weeks. 

In her presentation at the EASD meeting, Dr. Gasiorek focused on results of the 12-week multiple ascending dose schedule with amycretin 50 mg (n = 16), amycretin 2 × 50 mg (n = 16), and placebo (n = 12). 

The primary endpoint of the study was the number of treatment-emergent adverse events, while the area under the amycretin plasma concentration time curve and the maximum plasma concentration of amycretin were secondary endpoints. 

The researchers also added percentage change in body weight after 12 weeks of treatment as an exploratory endpoint. 
 

Safety Findings of Multiple Dosing

A total of 242 treatment-emergent adverse events were reported in the combined active and placebo groups and were of mild to moderate severity. 

Treatment-emergent adverse events were found in 75% of the amycretin 50 mg group, 93.8% of the amycretin 2 × 50 mg group, and 33.3% of placebo recipients.

“Most adverse events reported were mild to moderate in severity and related to gastrointestinal discomfort (nausea and vomiting) and occurred in a dose-proportional manner,” reported Dr. Gasiorek.

Gastrointestinal events were experienced by 50%, 87.5%, and 16.7% of participants receiving amycretin 50 mg, amycretin 2 × 50 mg, and placebo, respectively (112 in total). 

Decreased appetite was also found in 56.3%, 81.3%, and 16.7% of the amycretin 50 mg, amycretin 2 × 50 mg, and placebo groups, respectively.

Two serious adverse events occurred, one of which was acute cholecystitis and the other diabetic ketoacidosis; “however, the [latter] participant was found to have autoantibodies for beta cells before treatment and was later diagnosed with type 1 diabetes,” Dr. Gasiorek said.
 

Body Weight Reduction 

Participants on 50 mg amycretin lost an average of 10.4% of their body weight (estimated treatment difference vs placebo, –9.2; 95% CI, –12.0 to –6.5), whereas those on 2 × 50 mg amycretin lost 13.1% of their body weight (estimated treatment difference vs placebo, –11.8; 95% CI, –14.6 to –9.0). Placebo group participants lost 1.2% of their body weight over the 12 weeks. 

Although no plateauing of weight loss was seen, said Dr. Gasiorek, it is important to consider the relatively short treatment duration and the limited time on the final dose, which could potentially introduce bias.

To date, weight loss medications based on GLP-1 RA technology are injectables. A combination of the injectable amylin analogue cagrilintide and the GLP-1 RA semaglutide is also being explored as a subcutaneous treatment solution.

In a comment, Martin Holst Lange, MD, PhD, executive vice president of development at Novo Nordisk, said that “amycretin is the first treatment to harness the two distinct biological pathways stimulated by amylin and GLP-1 in a single molecule.”

The safety and tolerability profiles and the magnitude of weight loss support further development of amycretin in patients with overweight or obesity, said Dr. Lange, who noted that the company was awaiting data from the ongoing phase 1 trial with subcutaneous amycretin, expected in 2025.

Having heard the presentation, co-moderator Timo Müller, PhD, professor at Ludwig Maximilian University of Munich, Germany, gave a considered response. “The drug was relatively well tolerated, with the typical GLP-1–induced GI [gastrointestinal] adverse effects being the most frequently reported.”

But he pointed out that questions remain. “We still need to know whether, at the given dose, the drug outperforms best-in-class drugs like semaglutide or tirzepatide at the highest approved doses. Furthermore, it warrants clarification if and to what extent the activation of the amylin receptor contributes to the shown effect and if and to what extent the glycemic benefits result from activation of the glucagon receptor (amylin improved glycemia by decreasing the secretion of glucagon). In any way, the current data remain friendly and support phase 2 development.” 
 

Oral Meds Could Bring Down Cost

Commenting on the data, Nerys Astbury, PhD, associate professor of diet and obesity at Nuffield Department of Primary Health Care Sciences, University of Oxford, England, said, “It is important to note that whilst the participants in this trial did lose weight over the 12-week study — and this was statistically more weight than in the placebo group — this study was not designed or powered to detect differences in body weight over longer periods of time.” 

If the results are confirmed in future studies, amycretin might widen the treatment options and introduce competition, probably bringing down the costs in the longer-term, said Dr. Astbury, who welcomes the prospect. 

“It is possible that some people might find the oral medications more acceptable than the injectable GLP-1 agonists currently available,” she said. And the current options are expensive, “which raises challenges to a taxpayer-funded health system like the NHS [National Health Service].” 

“Furthermore, if the growing number of oral obesity medications prove safe, tolerable, and effective ... they are likely to significantly reduce the risks of developing many complications of obesity.”

Naveed Sattar, MD, professor of cardiometabolic medicine and honorary consultant, University of Glasgow, Scotland, agreed. “The more medicines coming forward to treat obesity, the better,” he said. In particular, oral medications would be more easily available, and cheaper, “for the many millions around the world struggling with obesity and its complications.”

Dr. Gasiorek declares she is an employee of and a shareholder in Novo Nordisk. Dr. Astbury declares no financial disclosures. Dr. Sattar declares having consulted for several companies that make diabetes medicines but also contributed to several lifestyle trials. For Novo Nordisk, he has consulted for the company on advisory boards, but not on any of their weight loss drug trial committees, and he is on the steering committee for the ZEUS trial, which is not a weight loss trial product but an anti-inflammatory. He does not have any shares for any product in health etc. He declares consulting fees and/or speaker honoraria from Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi, and grant support paid to his university from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche Diagnostics. Dr. Müller received financial support or an honorarium from Novo Nordisk, Merck, Eli Lilly, Boehringer Ingelheim, and Mercodia; he further holds stocks at Novo Nordisk and Eli Lilly and is cofounder of Bluewater Biosciences.

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

MADRID — Amycretin, a dual-pathway, oral weight loss drug, led to up to 13% body weight loss in participants with overweight or obesity according to phase 1, first-in-human study data presented at the European Association for the Study of Diabetes (EASD) 2024 annual meeting.

Body weight loss was “remarkable for an orally delivered biologic,” said Agnes Gasiorek, PhD, senior clinical pharmacology specialist at Novo Nordisk, Måløv, Denmark, who presented the results. And “there was no plateauing of weight loss in the treatment period.”

The mean change in percentage body weight was –10.4% with amycretin 50 mg, –13.1% with amycretin 2 × 50 mg, and –1.2% with placebo after 12 weeks of treatment.

With respect to the primary endpoint, stepwise dose escalation demonstrated that all tested dose levels up to and including 2 × 50 mg over a 12-week escalation period were safe and tolerable, Dr. Gasiorek reported.

The adverse events were in line with what was expected from targeting these receptors, and no new safety signals appeared during the study, she added.
 

Dual Pathways

Amycretin is a novel protein-based unimolecular amylin combined with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) and is the first oral formulation of this combination under development.

The two components are both known to reduce appetite and energy intake and increase satiety, said Dr. Gasiorek, but amylin is considered to potentially increase leptin sensitivity and GLP-1 RAs are known to increase insulin secretion and biosynthesis. Together, the two components improve insulin sensitivity, decrease glucagon secretion, and lead to acute delay in gastric emptying.

The single-center, placebo-controlled, double-blind phase 1 study enrolled men and women aged 18-55 years (mean, 38-42 years across groups) with a body mass index of 25.0-39.9, without diabetes, and considered otherwise healthy. 

Participants were randomly assigned to receive to receive oral amycretin (n = 95) or placebo (n = 29) once a day for up to 12 weeks. Study arms comprised single-ascending dosing (increasing from 1 mg/d to 25 mg), and multiple-ascending dosing. The latter consisted of multiple ascending doses (from 3 to 12 mg) over 10 days and multiple ascending doses (stepwise dose escalation, from 3 mg up to a final dose of 2 × 50 mg) over 12 weeks. 

In her presentation at the EASD meeting, Dr. Gasiorek focused on results of the 12-week multiple ascending dose schedule with amycretin 50 mg (n = 16), amycretin 2 × 50 mg (n = 16), and placebo (n = 12). 

The primary endpoint of the study was the number of treatment-emergent adverse events, while the area under the amycretin plasma concentration time curve and the maximum plasma concentration of amycretin were secondary endpoints. 

The researchers also added percentage change in body weight after 12 weeks of treatment as an exploratory endpoint. 
 

Safety Findings of Multiple Dosing

A total of 242 treatment-emergent adverse events were reported in the combined active and placebo groups and were of mild to moderate severity. 

Treatment-emergent adverse events were found in 75% of the amycretin 50 mg group, 93.8% of the amycretin 2 × 50 mg group, and 33.3% of placebo recipients.

“Most adverse events reported were mild to moderate in severity and related to gastrointestinal discomfort (nausea and vomiting) and occurred in a dose-proportional manner,” reported Dr. Gasiorek.

Gastrointestinal events were experienced by 50%, 87.5%, and 16.7% of participants receiving amycretin 50 mg, amycretin 2 × 50 mg, and placebo, respectively (112 in total). 

Decreased appetite was also found in 56.3%, 81.3%, and 16.7% of the amycretin 50 mg, amycretin 2 × 50 mg, and placebo groups, respectively.

Two serious adverse events occurred, one of which was acute cholecystitis and the other diabetic ketoacidosis; “however, the [latter] participant was found to have autoantibodies for beta cells before treatment and was later diagnosed with type 1 diabetes,” Dr. Gasiorek said.
 

Body Weight Reduction 

Participants on 50 mg amycretin lost an average of 10.4% of their body weight (estimated treatment difference vs placebo, –9.2; 95% CI, –12.0 to –6.5), whereas those on 2 × 50 mg amycretin lost 13.1% of their body weight (estimated treatment difference vs placebo, –11.8; 95% CI, –14.6 to –9.0). Placebo group participants lost 1.2% of their body weight over the 12 weeks. 

Although no plateauing of weight loss was seen, said Dr. Gasiorek, it is important to consider the relatively short treatment duration and the limited time on the final dose, which could potentially introduce bias.

To date, weight loss medications based on GLP-1 RA technology are injectables. A combination of the injectable amylin analogue cagrilintide and the GLP-1 RA semaglutide is also being explored as a subcutaneous treatment solution.

In a comment, Martin Holst Lange, MD, PhD, executive vice president of development at Novo Nordisk, said that “amycretin is the first treatment to harness the two distinct biological pathways stimulated by amylin and GLP-1 in a single molecule.”

The safety and tolerability profiles and the magnitude of weight loss support further development of amycretin in patients with overweight or obesity, said Dr. Lange, who noted that the company was awaiting data from the ongoing phase 1 trial with subcutaneous amycretin, expected in 2025.

Having heard the presentation, co-moderator Timo Müller, PhD, professor at Ludwig Maximilian University of Munich, Germany, gave a considered response. “The drug was relatively well tolerated, with the typical GLP-1–induced GI [gastrointestinal] adverse effects being the most frequently reported.”

But he pointed out that questions remain. “We still need to know whether, at the given dose, the drug outperforms best-in-class drugs like semaglutide or tirzepatide at the highest approved doses. Furthermore, it warrants clarification if and to what extent the activation of the amylin receptor contributes to the shown effect and if and to what extent the glycemic benefits result from activation of the glucagon receptor (amylin improved glycemia by decreasing the secretion of glucagon). In any way, the current data remain friendly and support phase 2 development.” 
 

Oral Meds Could Bring Down Cost

Commenting on the data, Nerys Astbury, PhD, associate professor of diet and obesity at Nuffield Department of Primary Health Care Sciences, University of Oxford, England, said, “It is important to note that whilst the participants in this trial did lose weight over the 12-week study — and this was statistically more weight than in the placebo group — this study was not designed or powered to detect differences in body weight over longer periods of time.” 

If the results are confirmed in future studies, amycretin might widen the treatment options and introduce competition, probably bringing down the costs in the longer-term, said Dr. Astbury, who welcomes the prospect. 

“It is possible that some people might find the oral medications more acceptable than the injectable GLP-1 agonists currently available,” she said. And the current options are expensive, “which raises challenges to a taxpayer-funded health system like the NHS [National Health Service].” 

“Furthermore, if the growing number of oral obesity medications prove safe, tolerable, and effective ... they are likely to significantly reduce the risks of developing many complications of obesity.”

Naveed Sattar, MD, professor of cardiometabolic medicine and honorary consultant, University of Glasgow, Scotland, agreed. “The more medicines coming forward to treat obesity, the better,” he said. In particular, oral medications would be more easily available, and cheaper, “for the many millions around the world struggling with obesity and its complications.”

Dr. Gasiorek declares she is an employee of and a shareholder in Novo Nordisk. Dr. Astbury declares no financial disclosures. Dr. Sattar declares having consulted for several companies that make diabetes medicines but also contributed to several lifestyle trials. For Novo Nordisk, he has consulted for the company on advisory boards, but not on any of their weight loss drug trial committees, and he is on the steering committee for the ZEUS trial, which is not a weight loss trial product but an anti-inflammatory. He does not have any shares for any product in health etc. He declares consulting fees and/or speaker honoraria from Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi, and grant support paid to his university from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche Diagnostics. Dr. Müller received financial support or an honorarium from Novo Nordisk, Merck, Eli Lilly, Boehringer Ingelheim, and Mercodia; he further holds stocks at Novo Nordisk and Eli Lilly and is cofounder of Bluewater Biosciences.

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

MADRID — Amycretin, a dual-pathway, oral weight loss drug, led to up to 13% body weight loss in participants with overweight or obesity according to phase 1, first-in-human study data presented at the European Association for the Study of Diabetes (EASD) 2024 annual meeting.

Body weight loss was “remarkable for an orally delivered biologic,” said Agnes Gasiorek, PhD, senior clinical pharmacology specialist at Novo Nordisk, Måløv, Denmark, who presented the results. And “there was no plateauing of weight loss in the treatment period.”

The mean change in percentage body weight was –10.4% with amycretin 50 mg, –13.1% with amycretin 2 × 50 mg, and –1.2% with placebo after 12 weeks of treatment.

With respect to the primary endpoint, stepwise dose escalation demonstrated that all tested dose levels up to and including 2 × 50 mg over a 12-week escalation period were safe and tolerable, Dr. Gasiorek reported.

The adverse events were in line with what was expected from targeting these receptors, and no new safety signals appeared during the study, she added.
 

Dual Pathways

Amycretin is a novel protein-based unimolecular amylin combined with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) and is the first oral formulation of this combination under development.

The two components are both known to reduce appetite and energy intake and increase satiety, said Dr. Gasiorek, but amylin is considered to potentially increase leptin sensitivity and GLP-1 RAs are known to increase insulin secretion and biosynthesis. Together, the two components improve insulin sensitivity, decrease glucagon secretion, and lead to acute delay in gastric emptying.

The single-center, placebo-controlled, double-blind phase 1 study enrolled men and women aged 18-55 years (mean, 38-42 years across groups) with a body mass index of 25.0-39.9, without diabetes, and considered otherwise healthy. 

Participants were randomly assigned to receive to receive oral amycretin (n = 95) or placebo (n = 29) once a day for up to 12 weeks. Study arms comprised single-ascending dosing (increasing from 1 mg/d to 25 mg), and multiple-ascending dosing. The latter consisted of multiple ascending doses (from 3 to 12 mg) over 10 days and multiple ascending doses (stepwise dose escalation, from 3 mg up to a final dose of 2 × 50 mg) over 12 weeks. 

In her presentation at the EASD meeting, Dr. Gasiorek focused on results of the 12-week multiple ascending dose schedule with amycretin 50 mg (n = 16), amycretin 2 × 50 mg (n = 16), and placebo (n = 12). 

The primary endpoint of the study was the number of treatment-emergent adverse events, while the area under the amycretin plasma concentration time curve and the maximum plasma concentration of amycretin were secondary endpoints. 

The researchers also added percentage change in body weight after 12 weeks of treatment as an exploratory endpoint. 
 

Safety Findings of Multiple Dosing

A total of 242 treatment-emergent adverse events were reported in the combined active and placebo groups and were of mild to moderate severity. 

Treatment-emergent adverse events were found in 75% of the amycretin 50 mg group, 93.8% of the amycretin 2 × 50 mg group, and 33.3% of placebo recipients.

“Most adverse events reported were mild to moderate in severity and related to gastrointestinal discomfort (nausea and vomiting) and occurred in a dose-proportional manner,” reported Dr. Gasiorek.

Gastrointestinal events were experienced by 50%, 87.5%, and 16.7% of participants receiving amycretin 50 mg, amycretin 2 × 50 mg, and placebo, respectively (112 in total). 

Decreased appetite was also found in 56.3%, 81.3%, and 16.7% of the amycretin 50 mg, amycretin 2 × 50 mg, and placebo groups, respectively.

Two serious adverse events occurred, one of which was acute cholecystitis and the other diabetic ketoacidosis; “however, the [latter] participant was found to have autoantibodies for beta cells before treatment and was later diagnosed with type 1 diabetes,” Dr. Gasiorek said.
 

Body Weight Reduction 

Participants on 50 mg amycretin lost an average of 10.4% of their body weight (estimated treatment difference vs placebo, –9.2; 95% CI, –12.0 to –6.5), whereas those on 2 × 50 mg amycretin lost 13.1% of their body weight (estimated treatment difference vs placebo, –11.8; 95% CI, –14.6 to –9.0). Placebo group participants lost 1.2% of their body weight over the 12 weeks. 

Although no plateauing of weight loss was seen, said Dr. Gasiorek, it is important to consider the relatively short treatment duration and the limited time on the final dose, which could potentially introduce bias.

To date, weight loss medications based on GLP-1 RA technology are injectables. A combination of the injectable amylin analogue cagrilintide and the GLP-1 RA semaglutide is also being explored as a subcutaneous treatment solution.

In a comment, Martin Holst Lange, MD, PhD, executive vice president of development at Novo Nordisk, said that “amycretin is the first treatment to harness the two distinct biological pathways stimulated by amylin and GLP-1 in a single molecule.”

The safety and tolerability profiles and the magnitude of weight loss support further development of amycretin in patients with overweight or obesity, said Dr. Lange, who noted that the company was awaiting data from the ongoing phase 1 trial with subcutaneous amycretin, expected in 2025.

Having heard the presentation, co-moderator Timo Müller, PhD, professor at Ludwig Maximilian University of Munich, Germany, gave a considered response. “The drug was relatively well tolerated, with the typical GLP-1–induced GI [gastrointestinal] adverse effects being the most frequently reported.”

But he pointed out that questions remain. “We still need to know whether, at the given dose, the drug outperforms best-in-class drugs like semaglutide or tirzepatide at the highest approved doses. Furthermore, it warrants clarification if and to what extent the activation of the amylin receptor contributes to the shown effect and if and to what extent the glycemic benefits result from activation of the glucagon receptor (amylin improved glycemia by decreasing the secretion of glucagon). In any way, the current data remain friendly and support phase 2 development.” 
 

Oral Meds Could Bring Down Cost

Commenting on the data, Nerys Astbury, PhD, associate professor of diet and obesity at Nuffield Department of Primary Health Care Sciences, University of Oxford, England, said, “It is important to note that whilst the participants in this trial did lose weight over the 12-week study — and this was statistically more weight than in the placebo group — this study was not designed or powered to detect differences in body weight over longer periods of time.” 

If the results are confirmed in future studies, amycretin might widen the treatment options and introduce competition, probably bringing down the costs in the longer-term, said Dr. Astbury, who welcomes the prospect. 

“It is possible that some people might find the oral medications more acceptable than the injectable GLP-1 agonists currently available,” she said. And the current options are expensive, “which raises challenges to a taxpayer-funded health system like the NHS [National Health Service].” 

“Furthermore, if the growing number of oral obesity medications prove safe, tolerable, and effective ... they are likely to significantly reduce the risks of developing many complications of obesity.”

Naveed Sattar, MD, professor of cardiometabolic medicine and honorary consultant, University of Glasgow, Scotland, agreed. “The more medicines coming forward to treat obesity, the better,” he said. In particular, oral medications would be more easily available, and cheaper, “for the many millions around the world struggling with obesity and its complications.”

Dr. Gasiorek declares she is an employee of and a shareholder in Novo Nordisk. Dr. Astbury declares no financial disclosures. Dr. Sattar declares having consulted for several companies that make diabetes medicines but also contributed to several lifestyle trials. For Novo Nordisk, he has consulted for the company on advisory boards, but not on any of their weight loss drug trial committees, and he is on the steering committee for the ZEUS trial, which is not a weight loss trial product but an anti-inflammatory. He does not have any shares for any product in health etc. He declares consulting fees and/or speaker honoraria from Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi, and grant support paid to his university from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche Diagnostics. Dr. Müller received financial support or an honorarium from Novo Nordisk, Merck, Eli Lilly, Boehringer Ingelheim, and Mercodia; he further holds stocks at Novo Nordisk and Eli Lilly and is cofounder of Bluewater Biosciences.

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

At age 57, a senior scientific researcher in Santa Barbara, California, complained of chronic erectile dysfunction (ED) in what had been a sexually active marriage. “I just couldn’t get an erection, let alone sustain one. Apart from that, I maybe felt a bit tired but generally okay,” he said. Though seemingly well otherwise, 18 months later he was dead of a hereditary right-sided colon cancer.

While not all cases of ED are associated with a dire outcome, the genitourinary signals of ED and lower urinary tract symptoms (LUTS), especially nocturia, serve as sentinel indicators of the presence of, or risk factors for, serious chronic conditions. These commonly include cardiovascular disease (CVD), diabetes, and metabolic syndrome and are associated with obesity, depression, and obstructive sleep apnea.

Sometimes these serious conditions may stay under the radar until men seek help for ED or LUTS.

“We know that among men who had a heart attack, 50% had some degree of ED within 3 years of their cardiac event,” Sam Tafari, MBBS, of the Endocrine and Metabolic Unit at Royal Adelaide Hospital in Adelaide, South Australia, said in an interview.

That’s the bad news. The good news is that these two problems may specifically incentivize men to seek timely care for serious conditions they might otherwise not get, according to Dr. Tafari. And primary care doctors are ideally positioned to get men early multifaceted care. He recently coauthored a call to action on this issue in a review appearing in the Journal of Men’s Health.

In Dr. Tafari’s experience, most patients seeking urological care are unaware of the multiple conditions linked to ED and LUTS. “Many consider these to be due to issues like low testosterone, which actually make up a very small proportion of cases of ED,” he said. Aging, obesity, inactivity, smoking, alcohol abuse, and prescription and street drugs can also contribute to the development of ED.

In most affected men, ED is of vascular etiology, with endothelial dysfunction of the inner lining of blood vessels and smooth muscle the common denominator.

This dysfunction causes inadequate blood supply to both the coronary and the penile arteries, so ED and CVD are considered different manifestations of the same systemic disorder. Because the tumescence-controlling cavernosal vessels of the penis are considerably smaller, the same level of arteriopathy causes a more severe reduction in blood in the erectile tissue. As a result, ED often precedes CVD and presents an early opportunity to screen men for CVD.

As to the mechanisms behind LUTS, Peter N. Tsambarlis, MD, a urologist at Northwestern Medicine in Chicago, subscribes to the inflammation theory. “Suboptimal health issues such as high [blood] pressure, blood lipids, and blood glucose lead to chronic widespread inflammation, which makes the bladder less flexible as a storage vessel,” he explained. “It’s not able to stretch adequately overnight to hold the urine until morning.”
 

Ask Early, Ask Often

Jeffrey P. Weiss, MD, PhD, chair of the Department of Urology at SUNY Downstate Health Sciences University in Brooklyn, New York, has done research that uncovered a relationship between structural cardiac disease and nocturia. “So if you had to ask a patient a single question that would point to a global health issue, it would be ‘Do you have frequent nighttime urination,’ ” he said.

It’s never too soon to ask men about these symptoms, said Dr. Tsambarlis. The best time to raise issues of ED and LUTS is when a man enters primary care — regardless of age or absence of symptoms. “That way you have a baseline and can watch for changes and do early intervention as needed. Men don’t usually want to bring up sexual dysfunction or urinary health, but asking doesn’t need to dominate the visit,” he said.

Dr. Tafari recommends that primary care physicians adopt a targeted approach using ED and nocturia as entry points for engaging men in their healthcare. While acknowledging that primary care physicians have an ever-growing checklist of questions to ask patients and hardly need one more thing to screen for, he suggests asking two quick, and easy “before you go” genitourinary queries:

• Are you having trouble with erections or having sex?
• Are you getting up at night to pass urine more than once?

“The men really appreciate being asked,” he said. “But what worries me is all the men we don’t see who have these symptoms but don’t know they’re important, and no one is asking about them.”

Gideon Richards, MD, a urologist at the Northwell Health Physician Partners Smith Institute for Urology at Garden City, and director of Men’s Health, Central Region, for Northwell Health in New Hyde Park, both in New York, said erectile problems should not wait for specialty care. By the time men with ED are referred to urology, they may already have failed treatment with first-line phosphodiesterase 5 inhibitor therapy, he said. “A significant proportion will have arteriogenic erectile dysfunction, a measurable decrease in the amount of blood flow into the erectile bodies.”

Addressing the Issue

Addressing genitourinary-signaled issues has the double benefit of easing ED and LUTS and improving men’s health and longevity and may help narrow the worldwide gender gap in life expectancy. As a recent global analysis found, there’s a 5-year longevity disparity favoring women over men. Biology aside, men do not access healthcare as often as women, who consult their general practitioners regularly throughout their lifespan for multiple reasons, including reproductive care, and more screening programs are aimed at women.

Added Dr. Tsambarlis, “Men should know that losing weight and switching to a healthy lifestyle can improve sexual function about half as much as phosphodiesterase 5 inhibitors such as sildenafil [Viagra] or tadalafil [Cialis].”

“Many, however, would prefer just to take drugs rather than change their lifestyle and lose weight. There are certainly effective options available, but these are not uniformly effective,” said Dr. Weiss.

Dr. Tafari’s group is designing a short, simple, culturally acceptable screening tool for use in primary care practice and will monitor its impact on physician prescribing habits and overall men’s health outcomes.

Dr. Tafari received funding from the Hospital Research Foundation and Freemasons Centre for Male Health and Wellbeing in Adelaide, South Australia. Dr. Tafari, Dr. Tsambarlis, Dr. Weiss, and Dr. Richards had no relevant conflicts of interest to declare.
 

A version of this article appeared on Medscape.com.

At age 57, a senior scientific researcher in Santa Barbara, California, complained of chronic erectile dysfunction (ED) in what had been a sexually active marriage. “I just couldn’t get an erection, let alone sustain one. Apart from that, I maybe felt a bit tired but generally okay,” he said. Though seemingly well otherwise, 18 months later he was dead of a hereditary right-sided colon cancer.

While not all cases of ED are associated with a dire outcome, the genitourinary signals of ED and lower urinary tract symptoms (LUTS), especially nocturia, serve as sentinel indicators of the presence of, or risk factors for, serious chronic conditions. These commonly include cardiovascular disease (CVD), diabetes, and metabolic syndrome and are associated with obesity, depression, and obstructive sleep apnea.

Sometimes these serious conditions may stay under the radar until men seek help for ED or LUTS.

“We know that among men who had a heart attack, 50% had some degree of ED within 3 years of their cardiac event,” Sam Tafari, MBBS, of the Endocrine and Metabolic Unit at Royal Adelaide Hospital in Adelaide, South Australia, said in an interview.

That’s the bad news. The good news is that these two problems may specifically incentivize men to seek timely care for serious conditions they might otherwise not get, according to Dr. Tafari. And primary care doctors are ideally positioned to get men early multifaceted care. He recently coauthored a call to action on this issue in a review appearing in the Journal of Men’s Health.

In Dr. Tafari’s experience, most patients seeking urological care are unaware of the multiple conditions linked to ED and LUTS. “Many consider these to be due to issues like low testosterone, which actually make up a very small proportion of cases of ED,” he said. Aging, obesity, inactivity, smoking, alcohol abuse, and prescription and street drugs can also contribute to the development of ED.

In most affected men, ED is of vascular etiology, with endothelial dysfunction of the inner lining of blood vessels and smooth muscle the common denominator.

This dysfunction causes inadequate blood supply to both the coronary and the penile arteries, so ED and CVD are considered different manifestations of the same systemic disorder. Because the tumescence-controlling cavernosal vessels of the penis are considerably smaller, the same level of arteriopathy causes a more severe reduction in blood in the erectile tissue. As a result, ED often precedes CVD and presents an early opportunity to screen men for CVD.

As to the mechanisms behind LUTS, Peter N. Tsambarlis, MD, a urologist at Northwestern Medicine in Chicago, subscribes to the inflammation theory. “Suboptimal health issues such as high [blood] pressure, blood lipids, and blood glucose lead to chronic widespread inflammation, which makes the bladder less flexible as a storage vessel,” he explained. “It’s not able to stretch adequately overnight to hold the urine until morning.”
 

Ask Early, Ask Often

Jeffrey P. Weiss, MD, PhD, chair of the Department of Urology at SUNY Downstate Health Sciences University in Brooklyn, New York, has done research that uncovered a relationship between structural cardiac disease and nocturia. “So if you had to ask a patient a single question that would point to a global health issue, it would be ‘Do you have frequent nighttime urination,’ ” he said.

It’s never too soon to ask men about these symptoms, said Dr. Tsambarlis. The best time to raise issues of ED and LUTS is when a man enters primary care — regardless of age or absence of symptoms. “That way you have a baseline and can watch for changes and do early intervention as needed. Men don’t usually want to bring up sexual dysfunction or urinary health, but asking doesn’t need to dominate the visit,” he said.

Dr. Tafari recommends that primary care physicians adopt a targeted approach using ED and nocturia as entry points for engaging men in their healthcare. While acknowledging that primary care physicians have an ever-growing checklist of questions to ask patients and hardly need one more thing to screen for, he suggests asking two quick, and easy “before you go” genitourinary queries:

• Are you having trouble with erections or having sex?
• Are you getting up at night to pass urine more than once?

“The men really appreciate being asked,” he said. “But what worries me is all the men we don’t see who have these symptoms but don’t know they’re important, and no one is asking about them.”

Gideon Richards, MD, a urologist at the Northwell Health Physician Partners Smith Institute for Urology at Garden City, and director of Men’s Health, Central Region, for Northwell Health in New Hyde Park, both in New York, said erectile problems should not wait for specialty care. By the time men with ED are referred to urology, they may already have failed treatment with first-line phosphodiesterase 5 inhibitor therapy, he said. “A significant proportion will have arteriogenic erectile dysfunction, a measurable decrease in the amount of blood flow into the erectile bodies.”

Addressing the Issue

Addressing genitourinary-signaled issues has the double benefit of easing ED and LUTS and improving men’s health and longevity and may help narrow the worldwide gender gap in life expectancy. As a recent global analysis found, there’s a 5-year longevity disparity favoring women over men. Biology aside, men do not access healthcare as often as women, who consult their general practitioners regularly throughout their lifespan for multiple reasons, including reproductive care, and more screening programs are aimed at women.

Added Dr. Tsambarlis, “Men should know that losing weight and switching to a healthy lifestyle can improve sexual function about half as much as phosphodiesterase 5 inhibitors such as sildenafil [Viagra] or tadalafil [Cialis].”

“Many, however, would prefer just to take drugs rather than change their lifestyle and lose weight. There are certainly effective options available, but these are not uniformly effective,” said Dr. Weiss.

Dr. Tafari’s group is designing a short, simple, culturally acceptable screening tool for use in primary care practice and will monitor its impact on physician prescribing habits and overall men’s health outcomes.

Dr. Tafari received funding from the Hospital Research Foundation and Freemasons Centre for Male Health and Wellbeing in Adelaide, South Australia. Dr. Tafari, Dr. Tsambarlis, Dr. Weiss, and Dr. Richards had no relevant conflicts of interest to declare.
 

A version of this article appeared on Medscape.com.

At age 57, a senior scientific researcher in Santa Barbara, California, complained of chronic erectile dysfunction (ED) in what had been a sexually active marriage. “I just couldn’t get an erection, let alone sustain one. Apart from that, I maybe felt a bit tired but generally okay,” he said. Though seemingly well otherwise, 18 months later he was dead of a hereditary right-sided colon cancer.

While not all cases of ED are associated with a dire outcome, the genitourinary signals of ED and lower urinary tract symptoms (LUTS), especially nocturia, serve as sentinel indicators of the presence of, or risk factors for, serious chronic conditions. These commonly include cardiovascular disease (CVD), diabetes, and metabolic syndrome and are associated with obesity, depression, and obstructive sleep apnea.

Sometimes these serious conditions may stay under the radar until men seek help for ED or LUTS.

“We know that among men who had a heart attack, 50% had some degree of ED within 3 years of their cardiac event,” Sam Tafari, MBBS, of the Endocrine and Metabolic Unit at Royal Adelaide Hospital in Adelaide, South Australia, said in an interview.

That’s the bad news. The good news is that these two problems may specifically incentivize men to seek timely care for serious conditions they might otherwise not get, according to Dr. Tafari. And primary care doctors are ideally positioned to get men early multifaceted care. He recently coauthored a call to action on this issue in a review appearing in the Journal of Men’s Health.

In Dr. Tafari’s experience, most patients seeking urological care are unaware of the multiple conditions linked to ED and LUTS. “Many consider these to be due to issues like low testosterone, which actually make up a very small proportion of cases of ED,” he said. Aging, obesity, inactivity, smoking, alcohol abuse, and prescription and street drugs can also contribute to the development of ED.

In most affected men, ED is of vascular etiology, with endothelial dysfunction of the inner lining of blood vessels and smooth muscle the common denominator.

This dysfunction causes inadequate blood supply to both the coronary and the penile arteries, so ED and CVD are considered different manifestations of the same systemic disorder. Because the tumescence-controlling cavernosal vessels of the penis are considerably smaller, the same level of arteriopathy causes a more severe reduction in blood in the erectile tissue. As a result, ED often precedes CVD and presents an early opportunity to screen men for CVD.

As to the mechanisms behind LUTS, Peter N. Tsambarlis, MD, a urologist at Northwestern Medicine in Chicago, subscribes to the inflammation theory. “Suboptimal health issues such as high [blood] pressure, blood lipids, and blood glucose lead to chronic widespread inflammation, which makes the bladder less flexible as a storage vessel,” he explained. “It’s not able to stretch adequately overnight to hold the urine until morning.”
 

Ask Early, Ask Often

Jeffrey P. Weiss, MD, PhD, chair of the Department of Urology at SUNY Downstate Health Sciences University in Brooklyn, New York, has done research that uncovered a relationship between structural cardiac disease and nocturia. “So if you had to ask a patient a single question that would point to a global health issue, it would be ‘Do you have frequent nighttime urination,’ ” he said.

It’s never too soon to ask men about these symptoms, said Dr. Tsambarlis. The best time to raise issues of ED and LUTS is when a man enters primary care — regardless of age or absence of symptoms. “That way you have a baseline and can watch for changes and do early intervention as needed. Men don’t usually want to bring up sexual dysfunction or urinary health, but asking doesn’t need to dominate the visit,” he said.

Dr. Tafari recommends that primary care physicians adopt a targeted approach using ED and nocturia as entry points for engaging men in their healthcare. While acknowledging that primary care physicians have an ever-growing checklist of questions to ask patients and hardly need one more thing to screen for, he suggests asking two quick, and easy “before you go” genitourinary queries:

• Are you having trouble with erections or having sex?
• Are you getting up at night to pass urine more than once?

“The men really appreciate being asked,” he said. “But what worries me is all the men we don’t see who have these symptoms but don’t know they’re important, and no one is asking about them.”

Gideon Richards, MD, a urologist at the Northwell Health Physician Partners Smith Institute for Urology at Garden City, and director of Men’s Health, Central Region, for Northwell Health in New Hyde Park, both in New York, said erectile problems should not wait for specialty care. By the time men with ED are referred to urology, they may already have failed treatment with first-line phosphodiesterase 5 inhibitor therapy, he said. “A significant proportion will have arteriogenic erectile dysfunction, a measurable decrease in the amount of blood flow into the erectile bodies.”

Addressing the Issue

Addressing genitourinary-signaled issues has the double benefit of easing ED and LUTS and improving men’s health and longevity and may help narrow the worldwide gender gap in life expectancy. As a recent global analysis found, there’s a 5-year longevity disparity favoring women over men. Biology aside, men do not access healthcare as often as women, who consult their general practitioners regularly throughout their lifespan for multiple reasons, including reproductive care, and more screening programs are aimed at women.

Added Dr. Tsambarlis, “Men should know that losing weight and switching to a healthy lifestyle can improve sexual function about half as much as phosphodiesterase 5 inhibitors such as sildenafil [Viagra] or tadalafil [Cialis].”

“Many, however, would prefer just to take drugs rather than change their lifestyle and lose weight. There are certainly effective options available, but these are not uniformly effective,” said Dr. Weiss.

Dr. Tafari’s group is designing a short, simple, culturally acceptable screening tool for use in primary care practice and will monitor its impact on physician prescribing habits and overall men’s health outcomes.

Dr. Tafari received funding from the Hospital Research Foundation and Freemasons Centre for Male Health and Wellbeing in Adelaide, South Australia. Dr. Tafari, Dr. Tsambarlis, Dr. Weiss, and Dr. Richards had no relevant conflicts of interest to declare.
 

A version of this article appeared on Medscape.com.

MADRID — A daily 8-hour eating window controls blood glucose whether followed early or late in the day by people at risk for type 2 diabetes, showed a time-restricted eating (TRE) study presented at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

The study, examining shifting the time of day for the 8-hour eating window along with a tightly controlled diet, found that 8 hours of TRE — whether early or late in the day — led to a significant improvement in the time spent within a normal daily blood glucose range and in glycemic variability.

“We didn’t show a benefit in terms of early versus late TRE, but we did show a benefit of time-restricted eating within a window of 8 h/d,” said study lead Kelly Bowden Davies, MSc, PhD, from Manchester Metropolitan University, Manchester, England, when presenting the work. “It doesn’t matter when you restrict eating, but if you restrict it to 8 hours then, according to our study, it benefits glycemic control in people at risk of type 2 diabetes.”

The researcher added that the effect was seen after only 3 days, and “demonstrates its therapeutic role in adults at risk of type 2 diabetes, which warrants investigation in the longer term.”

The current study examined the effect of shifting the time of day for the TRE window from early (8 AM-4 PM) to late (12 PM-8 PM) in people at risk of developing type 2 diabetes due to a lifestyle characterized as sedentary and poor diet.

Previous studies indicate that TRE, which limits when, but not what, individuals eat, can improve insulin sensitivity and A1c in people at risk for type 2 diabetes.

But Dr. Bowden Davies pointed out that the effect of TRE on glycemic variability remained unclear. While prior work had attributed the positive effects of TRE to reduced energy intake, this study provided a diet where energy consumption matched energy expenditure — taking into account sex, age, weight, height, and activity level, termed a “eucaloric” diet.

“Some research groups recognize that if we manipulate the time at which we eat, then we can better align with circadian metabolic rhythms to improve whole body insulin sensitivity and glycemic variability,” explained Dr. Bowden Davies. “It may be that eating in the morning may be better aligned [with circadian rhythms] and cause greater improvement in glucose control.”
 

Three-Day TRE Plan Led to Blood Glucose Control

In a cross-over study design, all 15 participants were randomized to follow the early and late TRE regimens with a 7-day washout period in the middle. Participants had a mean body mass index (BMI) of 27.7 kg/m², had a mean waist circumference of 73 cm, were sedentary, and followed a poor diet.

“Participants were normoglycemic so had good glucose control, but due to having overweight and obesity, they are considered as having risk factors for the development of type 2 diabetes,” noted Dr. Bowden Davies.

Before the TRE period, participants provided researchers with a dietary record. If they started on the early TRE, they crossed over to the late TRE after the washout period, and vice versa, she explained.

Continuous glucose monitoring (FreeStyle Libre 2, Abbott Laboratories) was carried out across the study to assess the daily time spent in euglycemia (3.9-7.8 mmol/L) and provide markers of glycemic variability, including mean absolute glucose, coefficient of variation, and mean amplitude of glucose excursions. Blood draws both pre- and post-TRE period provided biochemical measurements, and anthropometric readings were also taken.

There were nine female participants, with a mean age of 52 years, a BMI of 28 kg/m², and an A1c level of 37.9 mmol/mol (5.6%). They tended to snack across an eating period of 14 h/d or more (habitual eating). They were assigned to two different investigational eating patterns for 3-day durations: Early or late, and these findings were compared with those from participants who continued their habitual eating.

Participants were provided with a eucaloric, standardized diet [50% carbohydrates, 30% fat, and 20% protein] to be eaten during the TRE period, whereas they ate as usual (ie, as and what they wanted) when not on the TRE regimen.

No changes were seen in the biochemistry markers assessed. “Given they only followed the TRE for 3 days, this is unsurprising,” remarked Dr. Bowden Davies. “We did see weight loss after only 3 days of TRE of around 1.1 kg across the two interventions,” she reported.

Referring to the early vs late TRE regimen, she added that “we didn’t see a benefit [no significant differences in glycemic control] of early compared with late TRE, but we did see a benefit of restricting the eating window to 8 h/d, so both conditions [early and late TRE regimens] had a benefit on glucose control.”

Variables of blood glucose control were also reduced while on the TRE regimen compared with habitual eating (more than 14 h/d), with significantly increased time spent within the normal blood glucose range on average by 3.3%, and also reduced mean absolute glucose by 0.6 mmol/L, coefficient of variation by 2.6%, and mean amplitude of glucose excursions by 0.4 mmol/L.

“Within 3 days, this is quite striking,” Dr. Bowden Davies pointed out.

She added that these data were interim analyses, but “these are positive in terms of participants seeing a benefit in glucose control and glycemic variability, which is a risk factor for developing type 2 diabetes but also for microvascular complications. We also saw improved time in range in terms of tight glucose control.

“Even in 3 days, there were small, subtle differences which are subclinical — but this is not a clinical cohort. The results are statistically significant and a promising piece of data to suggest a feasible intervention that could be translated across different populations,” she said, adding that over a longer time period, changes between TRE timing might show changes in people at risk for type 2 diabetes who don’t have compromised circadian rhythms.

Moderating the session was Lutgarda Bozzetto, MD, from the University of Naples Federico II, Naples, Italy. She told this news organization, “It’s a hot topic right now, and the finding that there’s no difference in the time of day when the restricted eating is done suggests that in people at risk of diabetes, the hormonal flux and cycle involved in blood glucose control is not so strong or sensitive.”

Using a continuous glucose monitor, they can look at their blood glucose levels after eating, and this might “be powerful in guiding behavioral change,” said Dr. Bozzetto.

Abbott Laboratories funded the continuous glucose monitoring. Neither Dr. Bowden Davies nor Dr. Bozzetto had any other relevant financial disclosures.

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

MADRID — A daily 8-hour eating window controls blood glucose whether followed early or late in the day by people at risk for type 2 diabetes, showed a time-restricted eating (TRE) study presented at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

The study, examining shifting the time of day for the 8-hour eating window along with a tightly controlled diet, found that 8 hours of TRE — whether early or late in the day — led to a significant improvement in the time spent within a normal daily blood glucose range and in glycemic variability.

“We didn’t show a benefit in terms of early versus late TRE, but we did show a benefit of time-restricted eating within a window of 8 h/d,” said study lead Kelly Bowden Davies, MSc, PhD, from Manchester Metropolitan University, Manchester, England, when presenting the work. “It doesn’t matter when you restrict eating, but if you restrict it to 8 hours then, according to our study, it benefits glycemic control in people at risk of type 2 diabetes.”

The researcher added that the effect was seen after only 3 days, and “demonstrates its therapeutic role in adults at risk of type 2 diabetes, which warrants investigation in the longer term.”

The current study examined the effect of shifting the time of day for the TRE window from early (8 AM-4 PM) to late (12 PM-8 PM) in people at risk of developing type 2 diabetes due to a lifestyle characterized as sedentary and poor diet.

Previous studies indicate that TRE, which limits when, but not what, individuals eat, can improve insulin sensitivity and A1c in people at risk for type 2 diabetes.

But Dr. Bowden Davies pointed out that the effect of TRE on glycemic variability remained unclear. While prior work had attributed the positive effects of TRE to reduced energy intake, this study provided a diet where energy consumption matched energy expenditure — taking into account sex, age, weight, height, and activity level, termed a “eucaloric” diet.

“Some research groups recognize that if we manipulate the time at which we eat, then we can better align with circadian metabolic rhythms to improve whole body insulin sensitivity and glycemic variability,” explained Dr. Bowden Davies. “It may be that eating in the morning may be better aligned [with circadian rhythms] and cause greater improvement in glucose control.”
 

Three-Day TRE Plan Led to Blood Glucose Control

In a cross-over study design, all 15 participants were randomized to follow the early and late TRE regimens with a 7-day washout period in the middle. Participants had a mean body mass index (BMI) of 27.7 kg/m², had a mean waist circumference of 73 cm, were sedentary, and followed a poor diet.

“Participants were normoglycemic so had good glucose control, but due to having overweight and obesity, they are considered as having risk factors for the development of type 2 diabetes,” noted Dr. Bowden Davies.

Before the TRE period, participants provided researchers with a dietary record. If they started on the early TRE, they crossed over to the late TRE after the washout period, and vice versa, she explained.

Continuous glucose monitoring (FreeStyle Libre 2, Abbott Laboratories) was carried out across the study to assess the daily time spent in euglycemia (3.9-7.8 mmol/L) and provide markers of glycemic variability, including mean absolute glucose, coefficient of variation, and mean amplitude of glucose excursions. Blood draws both pre- and post-TRE period provided biochemical measurements, and anthropometric readings were also taken.

There were nine female participants, with a mean age of 52 years, a BMI of 28 kg/m², and an A1c level of 37.9 mmol/mol (5.6%). They tended to snack across an eating period of 14 h/d or more (habitual eating). They were assigned to two different investigational eating patterns for 3-day durations: Early or late, and these findings were compared with those from participants who continued their habitual eating.

Participants were provided with a eucaloric, standardized diet [50% carbohydrates, 30% fat, and 20% protein] to be eaten during the TRE period, whereas they ate as usual (ie, as and what they wanted) when not on the TRE regimen.

No changes were seen in the biochemistry markers assessed. “Given they only followed the TRE for 3 days, this is unsurprising,” remarked Dr. Bowden Davies. “We did see weight loss after only 3 days of TRE of around 1.1 kg across the two interventions,” she reported.

Referring to the early vs late TRE regimen, she added that “we didn’t see a benefit [no significant differences in glycemic control] of early compared with late TRE, but we did see a benefit of restricting the eating window to 8 h/d, so both conditions [early and late TRE regimens] had a benefit on glucose control.”

Variables of blood glucose control were also reduced while on the TRE regimen compared with habitual eating (more than 14 h/d), with significantly increased time spent within the normal blood glucose range on average by 3.3%, and also reduced mean absolute glucose by 0.6 mmol/L, coefficient of variation by 2.6%, and mean amplitude of glucose excursions by 0.4 mmol/L.

“Within 3 days, this is quite striking,” Dr. Bowden Davies pointed out.

She added that these data were interim analyses, but “these are positive in terms of participants seeing a benefit in glucose control and glycemic variability, which is a risk factor for developing type 2 diabetes but also for microvascular complications. We also saw improved time in range in terms of tight glucose control.

“Even in 3 days, there were small, subtle differences which are subclinical — but this is not a clinical cohort. The results are statistically significant and a promising piece of data to suggest a feasible intervention that could be translated across different populations,” she said, adding that over a longer time period, changes between TRE timing might show changes in people at risk for type 2 diabetes who don’t have compromised circadian rhythms.

Moderating the session was Lutgarda Bozzetto, MD, from the University of Naples Federico II, Naples, Italy. She told this news organization, “It’s a hot topic right now, and the finding that there’s no difference in the time of day when the restricted eating is done suggests that in people at risk of diabetes, the hormonal flux and cycle involved in blood glucose control is not so strong or sensitive.”

Using a continuous glucose monitor, they can look at their blood glucose levels after eating, and this might “be powerful in guiding behavioral change,” said Dr. Bozzetto.

Abbott Laboratories funded the continuous glucose monitoring. Neither Dr. Bowden Davies nor Dr. Bozzetto had any other relevant financial disclosures.

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

MADRID — A daily 8-hour eating window controls blood glucose whether followed early or late in the day by people at risk for type 2 diabetes, showed a time-restricted eating (TRE) study presented at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

The study, examining shifting the time of day for the 8-hour eating window along with a tightly controlled diet, found that 8 hours of TRE — whether early or late in the day — led to a significant improvement in the time spent within a normal daily blood glucose range and in glycemic variability.

“We didn’t show a benefit in terms of early versus late TRE, but we did show a benefit of time-restricted eating within a window of 8 h/d,” said study lead Kelly Bowden Davies, MSc, PhD, from Manchester Metropolitan University, Manchester, England, when presenting the work. “It doesn’t matter when you restrict eating, but if you restrict it to 8 hours then, according to our study, it benefits glycemic control in people at risk of type 2 diabetes.”

The researcher added that the effect was seen after only 3 days, and “demonstrates its therapeutic role in adults at risk of type 2 diabetes, which warrants investigation in the longer term.”

The current study examined the effect of shifting the time of day for the TRE window from early (8 AM-4 PM) to late (12 PM-8 PM) in people at risk of developing type 2 diabetes due to a lifestyle characterized as sedentary and poor diet.

Previous studies indicate that TRE, which limits when, but not what, individuals eat, can improve insulin sensitivity and A1c in people at risk for type 2 diabetes.

But Dr. Bowden Davies pointed out that the effect of TRE on glycemic variability remained unclear. While prior work had attributed the positive effects of TRE to reduced energy intake, this study provided a diet where energy consumption matched energy expenditure — taking into account sex, age, weight, height, and activity level, termed a “eucaloric” diet.

“Some research groups recognize that if we manipulate the time at which we eat, then we can better align with circadian metabolic rhythms to improve whole body insulin sensitivity and glycemic variability,” explained Dr. Bowden Davies. “It may be that eating in the morning may be better aligned [with circadian rhythms] and cause greater improvement in glucose control.”
 

Three-Day TRE Plan Led to Blood Glucose Control

In a cross-over study design, all 15 participants were randomized to follow the early and late TRE regimens with a 7-day washout period in the middle. Participants had a mean body mass index (BMI) of 27.7 kg/m², had a mean waist circumference of 73 cm, were sedentary, and followed a poor diet.

“Participants were normoglycemic so had good glucose control, but due to having overweight and obesity, they are considered as having risk factors for the development of type 2 diabetes,” noted Dr. Bowden Davies.

Before the TRE period, participants provided researchers with a dietary record. If they started on the early TRE, they crossed over to the late TRE after the washout period, and vice versa, she explained.

Continuous glucose monitoring (FreeStyle Libre 2, Abbott Laboratories) was carried out across the study to assess the daily time spent in euglycemia (3.9-7.8 mmol/L) and provide markers of glycemic variability, including mean absolute glucose, coefficient of variation, and mean amplitude of glucose excursions. Blood draws both pre- and post-TRE period provided biochemical measurements, and anthropometric readings were also taken.

There were nine female participants, with a mean age of 52 years, a BMI of 28 kg/m², and an A1c level of 37.9 mmol/mol (5.6%). They tended to snack across an eating period of 14 h/d or more (habitual eating). They were assigned to two different investigational eating patterns for 3-day durations: Early or late, and these findings were compared with those from participants who continued their habitual eating.

Participants were provided with a eucaloric, standardized diet [50% carbohydrates, 30% fat, and 20% protein] to be eaten during the TRE period, whereas they ate as usual (ie, as and what they wanted) when not on the TRE regimen.

No changes were seen in the biochemistry markers assessed. “Given they only followed the TRE for 3 days, this is unsurprising,” remarked Dr. Bowden Davies. “We did see weight loss after only 3 days of TRE of around 1.1 kg across the two interventions,” she reported.

Referring to the early vs late TRE regimen, she added that “we didn’t see a benefit [no significant differences in glycemic control] of early compared with late TRE, but we did see a benefit of restricting the eating window to 8 h/d, so both conditions [early and late TRE regimens] had a benefit on glucose control.”

Variables of blood glucose control were also reduced while on the TRE regimen compared with habitual eating (more than 14 h/d), with significantly increased time spent within the normal blood glucose range on average by 3.3%, and also reduced mean absolute glucose by 0.6 mmol/L, coefficient of variation by 2.6%, and mean amplitude of glucose excursions by 0.4 mmol/L.

“Within 3 days, this is quite striking,” Dr. Bowden Davies pointed out.

She added that these data were interim analyses, but “these are positive in terms of participants seeing a benefit in glucose control and glycemic variability, which is a risk factor for developing type 2 diabetes but also for microvascular complications. We also saw improved time in range in terms of tight glucose control.

“Even in 3 days, there were small, subtle differences which are subclinical — but this is not a clinical cohort. The results are statistically significant and a promising piece of data to suggest a feasible intervention that could be translated across different populations,” she said, adding that over a longer time period, changes between TRE timing might show changes in people at risk for type 2 diabetes who don’t have compromised circadian rhythms.

Moderating the session was Lutgarda Bozzetto, MD, from the University of Naples Federico II, Naples, Italy. She told this news organization, “It’s a hot topic right now, and the finding that there’s no difference in the time of day when the restricted eating is done suggests that in people at risk of diabetes, the hormonal flux and cycle involved in blood glucose control is not so strong or sensitive.”

Using a continuous glucose monitor, they can look at their blood glucose levels after eating, and this might “be powerful in guiding behavioral change,” said Dr. Bozzetto.

Abbott Laboratories funded the continuous glucose monitoring. Neither Dr. Bowden Davies nor Dr. Bozzetto had any other relevant financial disclosures.

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

You may have been warned that ultra-processed foods can wreak havoc on your health. But not all of them are created equal. 

A new study out of The Lancet Regional Health – Americas looked at different types of ultra-processed foods and found that some were even linked with lower risks of cardiovascular disease, coronary heart disease, and stroke, 

“Avoiding all ultra-processed foods is not practical for most people,” said Dariush Mozaffarian, MD, a cardiologist, public health scientist, and director of the Food is Medicine Institute at Tufts University in Boston, Massachusetts. “So, it is helpful to start to understand, within the category of all processing, what food might be more or less harmful.”

Researchers analyzed food questionnaires from three large groups of US adults, with most people in their review being White and female. The study found that sugary and artificially sweetened drinks, along with processed meats, were linked to a greater risk of cardiovascular disease and coronary heart disease. But cereals, savory snacks, and yogurt and dairy-based desserts were linked to a lower risk of these diseases. Ultra-processed cereals and breads were also linked to a lower stroke risk. 
 

The Truth About Processed Meat

Studies show that cured, salted, or smoked meats are linked to certain cancers.

“We know that sugar-sweetened beverages are associated with metabolic derangement for things like higher glucose levels, insulin resistance, visceral obesity, prediabetes, diabetes, and higher triglycerides,” said Ashish Sarraju, MD, a cardiologist with the Cleveland Clinic in Ohio. “Added sugars associated with all of those things are in turn risk factors for heart disease.” Sugar-sweetened beverages are often very high in sugar, artificial colors, and other additives, and almost “nothing beneficial” in terms of ingredients, Dr. Mozaffarian said. “They’re also consumed in very high doses, very quickly.”

Processed meats have 400% higher levels of salt, compared with unprocessed meats, said Dr. Mozaffarian. They also contain high levels of added nitrates, which are a carcinogen that could also affect the heart and blood vessels. Certain ultra-processed foods, such as bacon, are often fried at sky-high temperatures, which can trigger inflammatory compounds. 

“If you put together the inflammatory effects, the salt, and the nitrates, this is a package of food that can really build to cause harm,” said Dr. Mozaffarian. The World Health Organization has also classified processed meats (bacon, ham, salami) as a group one carcinogen, he noted.

“Processed meats are typically high in saturated fats, sodium, and preservatives, which can increase blood pressure, promote inflammation, and negatively affect cholesterol levels, leading to a higher risk of coronary heart disease, said Joseph A. Daibes, DO, an interventional cardiologist at Lenox Hill Hospital, New York City. “The study underscores the importance of limiting these types of foods to reduce cardiovascular risk.”

But considering that breakfast cereals – albeit highly processed – are a top source of whole grains for Americans, it makes sense that they are linked with lower risk of heart disease, said Dr. Mozaffarian. 

“They have fiber, bran, whole grains, and they also have sugar, and additives,” he said. “But on average, putting all those things together, this study suggested that the net effect is beneficial. That doesn’t mean they couldn’t be more beneficial if we made them less processed, but they don’t seem to have harm.”

The active probiotics and fermentation in yogurt can make it a healthy snack of choice, as there has been more and more research showing that fermented foods with probiotics are good for heart health and work against metabolic disease, or a cluster of conditions that can increase the risk of stroke, heart disease, and type 2 diabetes, Dr. Mozaffarian said.

Savory snacks, cereals, and yogurt and dairy-based desserts may also be less calorie dense than sugary beverages and processed meats, said Dr. Daibes. 

“Additionally, the type of fat used in savory snacks and the presence of probiotics in yogurt may have neutral or even positive effects on heart health, as opposed to the harmful fats and additives found in many ultra-processed foods,” he said.
 

How Ultra-Processed Foods Can Harm Your Health 

There are “clear and concerning links” between eating ultra-processed foods and getting heart disease, according to Dr. Daibes. “In real-life clinical practice, it’s a rather clear and straightforward relationship – the patients who tend to have poorer diets, with more ultra-processed and nutrient-barren foods, tend to have worse health outcomes, both cardiovascular and otherwise.”

Processing foods is centered on breaking down the natural structures of foods, as well as the loss of their natural nutrients, Dr. Mozaffarian explained. When you include the word “ultra,” this refers to putting in industrial additives.

“I think refined starches (such as wheat, corn, and rice) and sugars are some of the biggest harms because it leads to a big spike in blood glucose,” Dr. Mozaffarian said. “But also, those refined starches and sugars are digested so quickly in the stomach and small intestine that you starve your gut bacteria in your large intestines.” 

Many “good-for-you ingredients,” such as fermentable fibers and bio-active compounds, are found in unprocessed, whole foods like fruits, vegetables, nuts, beans, and seeds, noted Dr. Mozaffarian. High levels of salt in ultra-processed foods are another cause for concern, as are other additives such as artificial flavorings, sweeteners, and thickeners. 
 

Opting for Whole Foods

There may be people looking to eat cleaner, unprocessed foods, but high cost and a lack of access to them could create challenges. Dr. Sarraju advises his patients to simply do their best to eat foods in their whole-ingredient form and avoid prepackaged foods as much as possible.

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

You may have been warned that ultra-processed foods can wreak havoc on your health. But not all of them are created equal. 

A new study out of The Lancet Regional Health – Americas looked at different types of ultra-processed foods and found that some were even linked with lower risks of cardiovascular disease, coronary heart disease, and stroke, 

“Avoiding all ultra-processed foods is not practical for most people,” said Dariush Mozaffarian, MD, a cardiologist, public health scientist, and director of the Food is Medicine Institute at Tufts University in Boston, Massachusetts. “So, it is helpful to start to understand, within the category of all processing, what food might be more or less harmful.”

Researchers analyzed food questionnaires from three large groups of US adults, with most people in their review being White and female. The study found that sugary and artificially sweetened drinks, along with processed meats, were linked to a greater risk of cardiovascular disease and coronary heart disease. But cereals, savory snacks, and yogurt and dairy-based desserts were linked to a lower risk of these diseases. Ultra-processed cereals and breads were also linked to a lower stroke risk. 
 

The Truth About Processed Meat

Studies show that cured, salted, or smoked meats are linked to certain cancers.

“We know that sugar-sweetened beverages are associated with metabolic derangement for things like higher glucose levels, insulin resistance, visceral obesity, prediabetes, diabetes, and higher triglycerides,” said Ashish Sarraju, MD, a cardiologist with the Cleveland Clinic in Ohio. “Added sugars associated with all of those things are in turn risk factors for heart disease.” Sugar-sweetened beverages are often very high in sugar, artificial colors, and other additives, and almost “nothing beneficial” in terms of ingredients, Dr. Mozaffarian said. “They’re also consumed in very high doses, very quickly.”

Processed meats have 400% higher levels of salt, compared with unprocessed meats, said Dr. Mozaffarian. They also contain high levels of added nitrates, which are a carcinogen that could also affect the heart and blood vessels. Certain ultra-processed foods, such as bacon, are often fried at sky-high temperatures, which can trigger inflammatory compounds. 

“If you put together the inflammatory effects, the salt, and the nitrates, this is a package of food that can really build to cause harm,” said Dr. Mozaffarian. The World Health Organization has also classified processed meats (bacon, ham, salami) as a group one carcinogen, he noted.

“Processed meats are typically high in saturated fats, sodium, and preservatives, which can increase blood pressure, promote inflammation, and negatively affect cholesterol levels, leading to a higher risk of coronary heart disease, said Joseph A. Daibes, DO, an interventional cardiologist at Lenox Hill Hospital, New York City. “The study underscores the importance of limiting these types of foods to reduce cardiovascular risk.”

But considering that breakfast cereals – albeit highly processed – are a top source of whole grains for Americans, it makes sense that they are linked with lower risk of heart disease, said Dr. Mozaffarian. 

“They have fiber, bran, whole grains, and they also have sugar, and additives,” he said. “But on average, putting all those things together, this study suggested that the net effect is beneficial. That doesn’t mean they couldn’t be more beneficial if we made them less processed, but they don’t seem to have harm.”

The active probiotics and fermentation in yogurt can make it a healthy snack of choice, as there has been more and more research showing that fermented foods with probiotics are good for heart health and work against metabolic disease, or a cluster of conditions that can increase the risk of stroke, heart disease, and type 2 diabetes, Dr. Mozaffarian said.

Savory snacks, cereals, and yogurt and dairy-based desserts may also be less calorie dense than sugary beverages and processed meats, said Dr. Daibes. 

“Additionally, the type of fat used in savory snacks and the presence of probiotics in yogurt may have neutral or even positive effects on heart health, as opposed to the harmful fats and additives found in many ultra-processed foods,” he said.
 

How Ultra-Processed Foods Can Harm Your Health 

There are “clear and concerning links” between eating ultra-processed foods and getting heart disease, according to Dr. Daibes. “In real-life clinical practice, it’s a rather clear and straightforward relationship – the patients who tend to have poorer diets, with more ultra-processed and nutrient-barren foods, tend to have worse health outcomes, both cardiovascular and otherwise.”

Processing foods is centered on breaking down the natural structures of foods, as well as the loss of their natural nutrients, Dr. Mozaffarian explained. When you include the word “ultra,” this refers to putting in industrial additives.

“I think refined starches (such as wheat, corn, and rice) and sugars are some of the biggest harms because it leads to a big spike in blood glucose,” Dr. Mozaffarian said. “But also, those refined starches and sugars are digested so quickly in the stomach and small intestine that you starve your gut bacteria in your large intestines.” 

Many “good-for-you ingredients,” such as fermentable fibers and bio-active compounds, are found in unprocessed, whole foods like fruits, vegetables, nuts, beans, and seeds, noted Dr. Mozaffarian. High levels of salt in ultra-processed foods are another cause for concern, as are other additives such as artificial flavorings, sweeteners, and thickeners. 
 

Opting for Whole Foods

There may be people looking to eat cleaner, unprocessed foods, but high cost and a lack of access to them could create challenges. Dr. Sarraju advises his patients to simply do their best to eat foods in their whole-ingredient form and avoid prepackaged foods as much as possible.

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

You may have been warned that ultra-processed foods can wreak havoc on your health. But not all of them are created equal. 

A new study out of The Lancet Regional Health – Americas looked at different types of ultra-processed foods and found that some were even linked with lower risks of cardiovascular disease, coronary heart disease, and stroke, 

“Avoiding all ultra-processed foods is not practical for most people,” said Dariush Mozaffarian, MD, a cardiologist, public health scientist, and director of the Food is Medicine Institute at Tufts University in Boston, Massachusetts. “So, it is helpful to start to understand, within the category of all processing, what food might be more or less harmful.”

Researchers analyzed food questionnaires from three large groups of US adults, with most people in their review being White and female. The study found that sugary and artificially sweetened drinks, along with processed meats, were linked to a greater risk of cardiovascular disease and coronary heart disease. But cereals, savory snacks, and yogurt and dairy-based desserts were linked to a lower risk of these diseases. Ultra-processed cereals and breads were also linked to a lower stroke risk. 
 

The Truth About Processed Meat

Studies show that cured, salted, or smoked meats are linked to certain cancers.

“We know that sugar-sweetened beverages are associated with metabolic derangement for things like higher glucose levels, insulin resistance, visceral obesity, prediabetes, diabetes, and higher triglycerides,” said Ashish Sarraju, MD, a cardiologist with the Cleveland Clinic in Ohio. “Added sugars associated with all of those things are in turn risk factors for heart disease.” Sugar-sweetened beverages are often very high in sugar, artificial colors, and other additives, and almost “nothing beneficial” in terms of ingredients, Dr. Mozaffarian said. “They’re also consumed in very high doses, very quickly.”

Processed meats have 400% higher levels of salt, compared with unprocessed meats, said Dr. Mozaffarian. They also contain high levels of added nitrates, which are a carcinogen that could also affect the heart and blood vessels. Certain ultra-processed foods, such as bacon, are often fried at sky-high temperatures, which can trigger inflammatory compounds. 

“If you put together the inflammatory effects, the salt, and the nitrates, this is a package of food that can really build to cause harm,” said Dr. Mozaffarian. The World Health Organization has also classified processed meats (bacon, ham, salami) as a group one carcinogen, he noted.

“Processed meats are typically high in saturated fats, sodium, and preservatives, which can increase blood pressure, promote inflammation, and negatively affect cholesterol levels, leading to a higher risk of coronary heart disease, said Joseph A. Daibes, DO, an interventional cardiologist at Lenox Hill Hospital, New York City. “The study underscores the importance of limiting these types of foods to reduce cardiovascular risk.”

But considering that breakfast cereals – albeit highly processed – are a top source of whole grains for Americans, it makes sense that they are linked with lower risk of heart disease, said Dr. Mozaffarian. 

“They have fiber, bran, whole grains, and they also have sugar, and additives,” he said. “But on average, putting all those things together, this study suggested that the net effect is beneficial. That doesn’t mean they couldn’t be more beneficial if we made them less processed, but they don’t seem to have harm.”

The active probiotics and fermentation in yogurt can make it a healthy snack of choice, as there has been more and more research showing that fermented foods with probiotics are good for heart health and work against metabolic disease, or a cluster of conditions that can increase the risk of stroke, heart disease, and type 2 diabetes, Dr. Mozaffarian said.

Savory snacks, cereals, and yogurt and dairy-based desserts may also be less calorie dense than sugary beverages and processed meats, said Dr. Daibes. 

“Additionally, the type of fat used in savory snacks and the presence of probiotics in yogurt may have neutral or even positive effects on heart health, as opposed to the harmful fats and additives found in many ultra-processed foods,” he said.
 

How Ultra-Processed Foods Can Harm Your Health 

There are “clear and concerning links” between eating ultra-processed foods and getting heart disease, according to Dr. Daibes. “In real-life clinical practice, it’s a rather clear and straightforward relationship – the patients who tend to have poorer diets, with more ultra-processed and nutrient-barren foods, tend to have worse health outcomes, both cardiovascular and otherwise.”

Processing foods is centered on breaking down the natural structures of foods, as well as the loss of their natural nutrients, Dr. Mozaffarian explained. When you include the word “ultra,” this refers to putting in industrial additives.

“I think refined starches (such as wheat, corn, and rice) and sugars are some of the biggest harms because it leads to a big spike in blood glucose,” Dr. Mozaffarian said. “But also, those refined starches and sugars are digested so quickly in the stomach and small intestine that you starve your gut bacteria in your large intestines.” 

Many “good-for-you ingredients,” such as fermentable fibers and bio-active compounds, are found in unprocessed, whole foods like fruits, vegetables, nuts, beans, and seeds, noted Dr. Mozaffarian. High levels of salt in ultra-processed foods are another cause for concern, as are other additives such as artificial flavorings, sweeteners, and thickeners. 
 

Opting for Whole Foods

There may be people looking to eat cleaner, unprocessed foods, but high cost and a lack of access to them could create challenges. Dr. Sarraju advises his patients to simply do their best to eat foods in their whole-ingredient form and avoid prepackaged foods as much as possible.

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

TOPLINE:

For older adults with obesity, bariatric surgery does not appear to significantly reduce the risk for obesity-related cancer and cardiovascular disease (CVD), as it does in younger adults.

METHODOLOGY:

• Bariatric surgery has been shown to decrease the risk for obesity-related cancer and CVD but is typically reserved for patients aged < 60 years. Whether the same holds for patients who undergo surgery at older ages is unclear.
• Researchers analyzed nationwide data from three countries (Denmark, Finland, and Sweden) to compare patients with no history of cancer or CVD and age ≥ 60 years who underwent bariatric surgery against matched controls who received nonoperative treatment for obesity.
• The main outcome was obesity-related cancer, defined as a composite outcome of breast, endometrial, esophageal, colorectal, and kidney cancer. The secondary outcome was CVD, defined as a composite of myocardial infarction, ischemic stroke, and cerebral hemorrhage.
• Analyses were adjusted for diabetes, hypertension, peripheral vascular disease, chronic obstructive pulmonary disease, kidney disease, and frailty.

TAKEAWAY:

• Of the 15,300 patients (66.4% women) included, 2550 underwent bariatric surgery (including gastric bypass in 1930) and 12,750 matched controls received nonoperative treatment for obesity.
• During a median 5.8 years of follow-up, 658 (4.3%) people developed obesity-related cancer and 1436 (9.4%) developed CVD.
• Bariatric surgery in adults aged ≥ 60 years was not associated with a reduced risk for obesity-related cancer (hazard ratio [HR], 0.81) or CVD (HR, 0.86) compared with matched nonoperative controls.
• Bariatric surgery appeared to be associated with a decreased risk for obesity-related cancer in women (HR, 0.76).
• There was a decreased risk for both obesity-related cancer (HR, 0.74) and CVD (HR, 0.82) in patients who underwent gastric bypass.

IN PRACTICE:

“The findings from this study suggest a limited role of bariatric surgery in older patients for the prevention of obesity-related cancer or cardiovascular disease,” the authors wrote, noting that this “may be explained by the poorer weight loss and resolution of comorbidities observed in patients who underwent surgery at an older age.”

SOURCE:

The study, with first author Peter Gerber, MD, PhD, Department of Surgery, Capio St Göran’s Hospital, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

Data on smoking status and body mass index were not available. The observational design limited the ability to draw causal inferences. The null association between bariatric surgery and outcomes may be due to limited power.

DISCLOSURES:

The study was funded by the Swedish Society of Medicine. The authors reported no conflicts of interest.

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

TOPLINE:

For older adults with obesity, bariatric surgery does not appear to significantly reduce the risk for obesity-related cancer and cardiovascular disease (CVD), as it does in younger adults.

METHODOLOGY:

• Bariatric surgery has been shown to decrease the risk for obesity-related cancer and CVD but is typically reserved for patients aged < 60 years. Whether the same holds for patients who undergo surgery at older ages is unclear.
• Researchers analyzed nationwide data from three countries (Denmark, Finland, and Sweden) to compare patients with no history of cancer or CVD and age ≥ 60 years who underwent bariatric surgery against matched controls who received nonoperative treatment for obesity.
• The main outcome was obesity-related cancer, defined as a composite outcome of breast, endometrial, esophageal, colorectal, and kidney cancer. The secondary outcome was CVD, defined as a composite of myocardial infarction, ischemic stroke, and cerebral hemorrhage.
• Analyses were adjusted for diabetes, hypertension, peripheral vascular disease, chronic obstructive pulmonary disease, kidney disease, and frailty.

TAKEAWAY:

• Of the 15,300 patients (66.4% women) included, 2550 underwent bariatric surgery (including gastric bypass in 1930) and 12,750 matched controls received nonoperative treatment for obesity.
• During a median 5.8 years of follow-up, 658 (4.3%) people developed obesity-related cancer and 1436 (9.4%) developed CVD.
• Bariatric surgery in adults aged ≥ 60 years was not associated with a reduced risk for obesity-related cancer (hazard ratio [HR], 0.81) or CVD (HR, 0.86) compared with matched nonoperative controls.
• Bariatric surgery appeared to be associated with a decreased risk for obesity-related cancer in women (HR, 0.76).
• There was a decreased risk for both obesity-related cancer (HR, 0.74) and CVD (HR, 0.82) in patients who underwent gastric bypass.

IN PRACTICE:

“The findings from this study suggest a limited role of bariatric surgery in older patients for the prevention of obesity-related cancer or cardiovascular disease,” the authors wrote, noting that this “may be explained by the poorer weight loss and resolution of comorbidities observed in patients who underwent surgery at an older age.”

SOURCE:

The study, with first author Peter Gerber, MD, PhD, Department of Surgery, Capio St Göran’s Hospital, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

Data on smoking status and body mass index were not available. The observational design limited the ability to draw causal inferences. The null association between bariatric surgery and outcomes may be due to limited power.

DISCLOSURES:

The study was funded by the Swedish Society of Medicine. The authors reported no conflicts of interest.

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

TOPLINE:

For older adults with obesity, bariatric surgery does not appear to significantly reduce the risk for obesity-related cancer and cardiovascular disease (CVD), as it does in younger adults.

METHODOLOGY:

• Bariatric surgery has been shown to decrease the risk for obesity-related cancer and CVD but is typically reserved for patients aged < 60 years. Whether the same holds for patients who undergo surgery at older ages is unclear.
• Researchers analyzed nationwide data from three countries (Denmark, Finland, and Sweden) to compare patients with no history of cancer or CVD and age ≥ 60 years who underwent bariatric surgery against matched controls who received nonoperative treatment for obesity.
• The main outcome was obesity-related cancer, defined as a composite outcome of breast, endometrial, esophageal, colorectal, and kidney cancer. The secondary outcome was CVD, defined as a composite of myocardial infarction, ischemic stroke, and cerebral hemorrhage.
• Analyses were adjusted for diabetes, hypertension, peripheral vascular disease, chronic obstructive pulmonary disease, kidney disease, and frailty.

TAKEAWAY:

• Of the 15,300 patients (66.4% women) included, 2550 underwent bariatric surgery (including gastric bypass in 1930) and 12,750 matched controls received nonoperative treatment for obesity.
• During a median 5.8 years of follow-up, 658 (4.3%) people developed obesity-related cancer and 1436 (9.4%) developed CVD.
• Bariatric surgery in adults aged ≥ 60 years was not associated with a reduced risk for obesity-related cancer (hazard ratio [HR], 0.81) or CVD (HR, 0.86) compared with matched nonoperative controls.
• Bariatric surgery appeared to be associated with a decreased risk for obesity-related cancer in women (HR, 0.76).
• There was a decreased risk for both obesity-related cancer (HR, 0.74) and CVD (HR, 0.82) in patients who underwent gastric bypass.

IN PRACTICE:

“The findings from this study suggest a limited role of bariatric surgery in older patients for the prevention of obesity-related cancer or cardiovascular disease,” the authors wrote, noting that this “may be explained by the poorer weight loss and resolution of comorbidities observed in patients who underwent surgery at an older age.”

SOURCE:

The study, with first author Peter Gerber, MD, PhD, Department of Surgery, Capio St Göran’s Hospital, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

Data on smoking status and body mass index were not available. The observational design limited the ability to draw causal inferences. The null association between bariatric surgery and outcomes may be due to limited power.

DISCLOSURES:

The study was funded by the Swedish Society of Medicine. The authors reported no conflicts of interest.

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

A diet in which the primary source of fat is plant sources is associated with decreased mortality. Animal fat, on the other hand, is associated with an increased risk for death. These are the results of a study published in JAMA Internal Medicine that followed more than 600,000 participants over 2 decades.

Bin Zhao, PhD, of the National Clinical Research Center for Metabolic Diseases at the Key Laboratory of Diabetes Immunology in Changsha, China, and colleagues concluded from these data that consuming plant-based fats instead of animal fats could be beneficial for health and improve survival.

It may not be so simple, however. “We are one step ahead of the publication: We no longer just distinguish between animal and plant fats but mainly consider the composition,” said Stefan Lorkowski, PhD, chair of biochemistry and physiology of nutrition at the Institute of Nutritional Sciences at the University of Jena in Germany, in response to inquiries from this news organization.
 

What’s in a Fat?

Although Dr. Zhao and colleagues studied the effect of different plant and animal fat sources (eg, grains, nuts, legumes, plant oils, red and white meat, dairy, eggs, and fish), they did not consider the composition of the fatty acids that they contained. “It matters which dairy products, which plant oils, and which fish are consumed,” said Dr. Lorkowski.

The data analyzed in the Chinese study come from a prospective cohort study (NIH-AARP Diet and Health Study) conducted in the United States from 1995 to 2019. At the beginning, the 407,531 study participants (average age, 61 years) filled out dietary questionnaires once. They were then followed for up to 24 years for total and cardiovascular mortality.

During this period, 185,111 study participants died, including 58,526 from cardiovascular diseases. Participants who consumed the most plant-based fats, according to the dietary questionnaires filled out in 1995, had a lower risk for death than those who consumed the least plant-based fats. Their overall mortality risk was 9% lower, and their cardiovascular mortality risk was 14% lower. This finding was especially noticeable when it came to plant fats from grains or plant oils.
 

Animal Fat and Mortality

In contrast, a higher intake of animal fat was associated with both a higher overall mortality risk (16%) and a higher cardiovascular mortality risk (14%). This was especially true for fat from dairy products and eggs.

A trend towards a reduced overall and cardiovascular mortality risk was observed for fat from fish. “The fact that only a trend towards fish consumption was observed may be due to the study having many more meat eaters than fish eaters,” said Dr. Lorkowski.

Another imbalance limits the significance of the study, he added. The two groups, those who primarily consumed plant fats and those who primarily consumed animal fats, were already distinct at the beginning of the study. Those who consumed more plant fats were more likely to have diabetes, a higher body mass index (BMI), higher energy intake, and higher alcohol consumption but consumed more fiber, fruits, and vegetables and were more physically active. “They may have been trying to live healthier because they were sicker,” said Dr. Lorkowski.
 

Potential Confounding

Dr. Zhao and his team adjusted the results for various potential confounding factors, including age, gender, BMI, ethnicity, smoking, physical activity, education, marital status, diabetes, health status, vitamin intake, protein, carbohydrates, fiber, trans fats, cholesterol intake, and alcohol consumption. However, according to Dr. Lorkowski, “statistical adjustment is always incomplete, and confounding cannot be completely ruled out.”

Nevertheless, these results provide relevant insights for dietary recommendations that could help improve health and related outcomes, according to the authors. “Replacement of 5% energy from animal fat with 5% energy from plant fat, particularly fat from grains or vegetable oils, was associated with a lower risk for mortality: 4%-24% reduction in overall mortality and 5%-30% reduction in cardiovascular disease mortality.”
 

Fat Composition Matters

Animal fat, however, should not simply be replaced with plant fat, said Dr. Lorkowski. “Cold-water fish, which provides important long-chain omega-3 fatty acids, is also considered animal fat. And palm and coconut fat, while plant-based, contain unhealthy long-chain saturated fats. And the type of plant oils also makes a difference, whether one uses corn germ or sunflower oil rich in omega-6 fatty acids or flaxseed or rapeseed oil rich in omega-3 fatty acids.

“A diet rich in unsaturated fats, with sufficient and balanced intake of omega-3 and omega-6 fatty acids, that is also abundant in fiber-rich carbohydrate sources and plant-based protein, is always better than too much fat from animal sources.”

This story was translated from the Medscape German 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.

A diet in which the primary source of fat is plant sources is associated with decreased mortality. Animal fat, on the other hand, is associated with an increased risk for death. These are the results of a study published in JAMA Internal Medicine that followed more than 600,000 participants over 2 decades.

Bin Zhao, PhD, of the National Clinical Research Center for Metabolic Diseases at the Key Laboratory of Diabetes Immunology in Changsha, China, and colleagues concluded from these data that consuming plant-based fats instead of animal fats could be beneficial for health and improve survival.

It may not be so simple, however. “We are one step ahead of the publication: We no longer just distinguish between animal and plant fats but mainly consider the composition,” said Stefan Lorkowski, PhD, chair of biochemistry and physiology of nutrition at the Institute of Nutritional Sciences at the University of Jena in Germany, in response to inquiries from this news organization.
 

What’s in a Fat?

Although Dr. Zhao and colleagues studied the effect of different plant and animal fat sources (eg, grains, nuts, legumes, plant oils, red and white meat, dairy, eggs, and fish), they did not consider the composition of the fatty acids that they contained. “It matters which dairy products, which plant oils, and which fish are consumed,” said Dr. Lorkowski.

The data analyzed in the Chinese study come from a prospective cohort study (NIH-AARP Diet and Health Study) conducted in the United States from 1995 to 2019. At the beginning, the 407,531 study participants (average age, 61 years) filled out dietary questionnaires once. They were then followed for up to 24 years for total and cardiovascular mortality.

During this period, 185,111 study participants died, including 58,526 from cardiovascular diseases. Participants who consumed the most plant-based fats, according to the dietary questionnaires filled out in 1995, had a lower risk for death than those who consumed the least plant-based fats. Their overall mortality risk was 9% lower, and their cardiovascular mortality risk was 14% lower. This finding was especially noticeable when it came to plant fats from grains or plant oils.
 

Animal Fat and Mortality

In contrast, a higher intake of animal fat was associated with both a higher overall mortality risk (16%) and a higher cardiovascular mortality risk (14%). This was especially true for fat from dairy products and eggs.

A trend towards a reduced overall and cardiovascular mortality risk was observed for fat from fish. “The fact that only a trend towards fish consumption was observed may be due to the study having many more meat eaters than fish eaters,” said Dr. Lorkowski.

Another imbalance limits the significance of the study, he added. The two groups, those who primarily consumed plant fats and those who primarily consumed animal fats, were already distinct at the beginning of the study. Those who consumed more plant fats were more likely to have diabetes, a higher body mass index (BMI), higher energy intake, and higher alcohol consumption but consumed more fiber, fruits, and vegetables and were more physically active. “They may have been trying to live healthier because they were sicker,” said Dr. Lorkowski.
 

Potential Confounding

Dr. Zhao and his team adjusted the results for various potential confounding factors, including age, gender, BMI, ethnicity, smoking, physical activity, education, marital status, diabetes, health status, vitamin intake, protein, carbohydrates, fiber, trans fats, cholesterol intake, and alcohol consumption. However, according to Dr. Lorkowski, “statistical adjustment is always incomplete, and confounding cannot be completely ruled out.”

Nevertheless, these results provide relevant insights for dietary recommendations that could help improve health and related outcomes, according to the authors. “Replacement of 5% energy from animal fat with 5% energy from plant fat, particularly fat from grains or vegetable oils, was associated with a lower risk for mortality: 4%-24% reduction in overall mortality and 5%-30% reduction in cardiovascular disease mortality.”
 

Fat Composition Matters

Animal fat, however, should not simply be replaced with plant fat, said Dr. Lorkowski. “Cold-water fish, which provides important long-chain omega-3 fatty acids, is also considered animal fat. And palm and coconut fat, while plant-based, contain unhealthy long-chain saturated fats. And the type of plant oils also makes a difference, whether one uses corn germ or sunflower oil rich in omega-6 fatty acids or flaxseed or rapeseed oil rich in omega-3 fatty acids.

“A diet rich in unsaturated fats, with sufficient and balanced intake of omega-3 and omega-6 fatty acids, that is also abundant in fiber-rich carbohydrate sources and plant-based protein, is always better than too much fat from animal sources.”

This story was translated from the Medscape German 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.

A diet in which the primary source of fat is plant sources is associated with decreased mortality. Animal fat, on the other hand, is associated with an increased risk for death. These are the results of a study published in JAMA Internal Medicine that followed more than 600,000 participants over 2 decades.

Bin Zhao, PhD, of the National Clinical Research Center for Metabolic Diseases at the Key Laboratory of Diabetes Immunology in Changsha, China, and colleagues concluded from these data that consuming plant-based fats instead of animal fats could be beneficial for health and improve survival.

It may not be so simple, however. “We are one step ahead of the publication: We no longer just distinguish between animal and plant fats but mainly consider the composition,” said Stefan Lorkowski, PhD, chair of biochemistry and physiology of nutrition at the Institute of Nutritional Sciences at the University of Jena in Germany, in response to inquiries from this news organization.
 

What’s in a Fat?

Although Dr. Zhao and colleagues studied the effect of different plant and animal fat sources (eg, grains, nuts, legumes, plant oils, red and white meat, dairy, eggs, and fish), they did not consider the composition of the fatty acids that they contained. “It matters which dairy products, which plant oils, and which fish are consumed,” said Dr. Lorkowski.

The data analyzed in the Chinese study come from a prospective cohort study (NIH-AARP Diet and Health Study) conducted in the United States from 1995 to 2019. At the beginning, the 407,531 study participants (average age, 61 years) filled out dietary questionnaires once. They were then followed for up to 24 years for total and cardiovascular mortality.

During this period, 185,111 study participants died, including 58,526 from cardiovascular diseases. Participants who consumed the most plant-based fats, according to the dietary questionnaires filled out in 1995, had a lower risk for death than those who consumed the least plant-based fats. Their overall mortality risk was 9% lower, and their cardiovascular mortality risk was 14% lower. This finding was especially noticeable when it came to plant fats from grains or plant oils.
 

Animal Fat and Mortality

In contrast, a higher intake of animal fat was associated with both a higher overall mortality risk (16%) and a higher cardiovascular mortality risk (14%). This was especially true for fat from dairy products and eggs.

A trend towards a reduced overall and cardiovascular mortality risk was observed for fat from fish. “The fact that only a trend towards fish consumption was observed may be due to the study having many more meat eaters than fish eaters,” said Dr. Lorkowski.

Another imbalance limits the significance of the study, he added. The two groups, those who primarily consumed plant fats and those who primarily consumed animal fats, were already distinct at the beginning of the study. Those who consumed more plant fats were more likely to have diabetes, a higher body mass index (BMI), higher energy intake, and higher alcohol consumption but consumed more fiber, fruits, and vegetables and were more physically active. “They may have been trying to live healthier because they were sicker,” said Dr. Lorkowski.
 

Potential Confounding

Dr. Zhao and his team adjusted the results for various potential confounding factors, including age, gender, BMI, ethnicity, smoking, physical activity, education, marital status, diabetes, health status, vitamin intake, protein, carbohydrates, fiber, trans fats, cholesterol intake, and alcohol consumption. However, according to Dr. Lorkowski, “statistical adjustment is always incomplete, and confounding cannot be completely ruled out.”

Nevertheless, these results provide relevant insights for dietary recommendations that could help improve health and related outcomes, according to the authors. “Replacement of 5% energy from animal fat with 5% energy from plant fat, particularly fat from grains or vegetable oils, was associated with a lower risk for mortality: 4%-24% reduction in overall mortality and 5%-30% reduction in cardiovascular disease mortality.”
 

Fat Composition Matters

Animal fat, however, should not simply be replaced with plant fat, said Dr. Lorkowski. “Cold-water fish, which provides important long-chain omega-3 fatty acids, is also considered animal fat. And palm and coconut fat, while plant-based, contain unhealthy long-chain saturated fats. And the type of plant oils also makes a difference, whether one uses corn germ or sunflower oil rich in omega-6 fatty acids or flaxseed or rapeseed oil rich in omega-3 fatty acids.

“A diet rich in unsaturated fats, with sufficient and balanced intake of omega-3 and omega-6 fatty acids, that is also abundant in fiber-rich carbohydrate sources and plant-based protein, is always better than too much fat from animal sources.”

This story was translated from the Medscape German 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:

MADRID — Elevated interleukin (IL) 6 levels are associated with an increased risk for obesity-related cancers in patients newly diagnosed with type 2 diabetes (T2D), potentially enabling the identification of higher-risk individuals through a simple blood test.

METHODOLOGY:

• T2D is associated with an increased risk for obesity-related cancers, including breast, renal, uterine, thyroid, ovarian, and gastrointestinal cancers, as well as multiple myeloma, possibly because of chronic low-grade inflammation.
• Researchers explored whether the markers of inflammation IL-6, tumor necrosis factor alpha (TNF-alpha), and high-sensitivity C-reactive protein (hsCRP) can serve as predictive biomarkers for obesity-related cancers in patients recently diagnosed with T2D.
• They identified patients with recent-onset T2D and no prior history of cancer participating in the ongoing Danish Centre for Strategic Research in Type 2 Diabetes cohort study.
• At study initiation, plasma levels of IL-6 and TNF-alpha were measured using Meso Scale Discovery assays, and serum levels of hsCRP were measured using immunofluorometric assays.

TAKEAWAY:

• Among 6,466 eligible patients (40.5% women; median age, 60.9 years), 327 developed obesity-related cancers over a median follow-up of 8.8 years.
• Each SD increase in log-transformed IL-6 levels increased the risk for obesity-related cancers by 19%.
• The researchers did not find a strong association between TNF-alpha or hsCRP and obesity-related cancers.
• The addition of baseline IL-6 levels to other well-known risk factors for obesity-related cancers improved the performance of a cancer prediction model from 0.685 to 0.693, translating to a small but important increase in the ability to predict whether an individual would develop one of these cancers.

IN PRACTICE:

“In future, a simple blood test could identify those at higher risk of the cancers,” said the study’s lead author in an accompanying press release.

SOURCE:

The study was led by Mathilde D. Bennetsen, Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark, and published online on August 27 as an early release from the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

LIMITATIONS:

No limitations were discussed in this abstract. However, the reliance on registry data may have introduced potential biases related to data accuracy and completeness.

DISCLOSURES:

The Danish Centre for Strategic Research in Type 2 Diabetes was supported by grants from the Danish Agency for Science and the Novo Nordisk Foundation. The authors declared no conflicts of interest.

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

TOPLINE:

MADRID — Elevated interleukin (IL) 6 levels are associated with an increased risk for obesity-related cancers in patients newly diagnosed with type 2 diabetes (T2D), potentially enabling the identification of higher-risk individuals through a simple blood test.

METHODOLOGY:

• T2D is associated with an increased risk for obesity-related cancers, including breast, renal, uterine, thyroid, ovarian, and gastrointestinal cancers, as well as multiple myeloma, possibly because of chronic low-grade inflammation.
• Researchers explored whether the markers of inflammation IL-6, tumor necrosis factor alpha (TNF-alpha), and high-sensitivity C-reactive protein (hsCRP) can serve as predictive biomarkers for obesity-related cancers in patients recently diagnosed with T2D.
• They identified patients with recent-onset T2D and no prior history of cancer participating in the ongoing Danish Centre for Strategic Research in Type 2 Diabetes cohort study.
• At study initiation, plasma levels of IL-6 and TNF-alpha were measured using Meso Scale Discovery assays, and serum levels of hsCRP were measured using immunofluorometric assays.

TAKEAWAY:

• Among 6,466 eligible patients (40.5% women; median age, 60.9 years), 327 developed obesity-related cancers over a median follow-up of 8.8 years.
• Each SD increase in log-transformed IL-6 levels increased the risk for obesity-related cancers by 19%.
• The researchers did not find a strong association between TNF-alpha or hsCRP and obesity-related cancers.
• The addition of baseline IL-6 levels to other well-known risk factors for obesity-related cancers improved the performance of a cancer prediction model from 0.685 to 0.693, translating to a small but important increase in the ability to predict whether an individual would develop one of these cancers.

IN PRACTICE:

“In future, a simple blood test could identify those at higher risk of the cancers,” said the study’s lead author in an accompanying press release.

SOURCE:

The study was led by Mathilde D. Bennetsen, Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark, and published online on August 27 as an early release from the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

LIMITATIONS:

No limitations were discussed in this abstract. However, the reliance on registry data may have introduced potential biases related to data accuracy and completeness.

DISCLOSURES:

The Danish Centre for Strategic Research in Type 2 Diabetes was supported by grants from the Danish Agency for Science and the Novo Nordisk Foundation. The authors declared no conflicts of interest.

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

TOPLINE:

MADRID — Elevated interleukin (IL) 6 levels are associated with an increased risk for obesity-related cancers in patients newly diagnosed with type 2 diabetes (T2D), potentially enabling the identification of higher-risk individuals through a simple blood test.

METHODOLOGY:

• T2D is associated with an increased risk for obesity-related cancers, including breast, renal, uterine, thyroid, ovarian, and gastrointestinal cancers, as well as multiple myeloma, possibly because of chronic low-grade inflammation.
• Researchers explored whether the markers of inflammation IL-6, tumor necrosis factor alpha (TNF-alpha), and high-sensitivity C-reactive protein (hsCRP) can serve as predictive biomarkers for obesity-related cancers in patients recently diagnosed with T2D.
• They identified patients with recent-onset T2D and no prior history of cancer participating in the ongoing Danish Centre for Strategic Research in Type 2 Diabetes cohort study.
• At study initiation, plasma levels of IL-6 and TNF-alpha were measured using Meso Scale Discovery assays, and serum levels of hsCRP were measured using immunofluorometric assays.

TAKEAWAY:

• Among 6,466 eligible patients (40.5% women; median age, 60.9 years), 327 developed obesity-related cancers over a median follow-up of 8.8 years.
• Each SD increase in log-transformed IL-6 levels increased the risk for obesity-related cancers by 19%.
• The researchers did not find a strong association between TNF-alpha or hsCRP and obesity-related cancers.
• The addition of baseline IL-6 levels to other well-known risk factors for obesity-related cancers improved the performance of a cancer prediction model from 0.685 to 0.693, translating to a small but important increase in the ability to predict whether an individual would develop one of these cancers.

IN PRACTICE:

“In future, a simple blood test could identify those at higher risk of the cancers,” said the study’s lead author in an accompanying press release.

SOURCE:

The study was led by Mathilde D. Bennetsen, Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark, and published online on August 27 as an early release from the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting.

LIMITATIONS:

No limitations were discussed in this abstract. However, the reliance on registry data may have introduced potential biases related to data accuracy and completeness.

DISCLOSURES:

The Danish Centre for Strategic Research in Type 2 Diabetes was supported by grants from the Danish Agency for Science and the Novo Nordisk Foundation. The authors declared no conflicts of interest.

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

TOPLINE:

MRI-derived abdominal adipose tissue is linked to chronic musculoskeletal pain in multiple sites. The association is stronger in women, suggesting sex differences in fat distribution and hormones.

METHODOLOGY:

• Researchers used data from the UK Biobank, a large population-based cohort study, to investigate the associations between MRI-measured abdominal adipose tissue and chronic musculoskeletal pain.
• A total of 32,409 participants (50.8% women; mean age, 55.0 ± 7.4 years) were included in the analysis, with abdominal MRI scans performed at two imaging visits.
• Pain in the neck/shoulder, back, hip, knee, or “all over the body” was assessed, and participants were categorized based on the number of chronic pain sites.
• Mixed-effects ordinal, multinomial, and logistic regression models were used to analyze the associations between visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and their ratio with chronic pain.

TAKEAWAY:

• According to the authors, there was a dose-response association between VAT, SAT, and their ratio with the number of chronic pain sites in both women and men.
• Higher levels of abdominal adipose tissue were associated with greater odds of reporting chronic pain in both sexes, with effect estimates being relatively larger in women.
• The researchers found that the VAT/SAT ratio was associated with the number of chronic pain sites and chronic pain in both sexes, reflecting differences in fat distribution and hormones.
• The study suggested that excessive abdominal adipose tissue may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain.

IN PRACTICE:

“Abdominal adipose tissue was associated with chronic musculoskeletal pain, suggesting that excessive and ectopic fat depositions may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain,” wrote the authors of the study.

SOURCE:

This study was led by Zemene Demelash Kifle, University of Tasmania Menzies Institute for Medical Research in Hobart, Australia. It was published online in Regional Anesthesia & Pain Medicine.

LIMITATIONS: 

The study’s limitations included the use of a pain questionnaire that did not assess pain severity, which limited the ability to examine the relationship between fat measures and pain severity. Additionally, MRI was conducted on only two occasions, which may have not captured patterns and fluctuations in chronic pain sites. The relatively small size of the imaging sample, compared with the original baseline sample limited the generalizability of the findings. The predominant White ethnicity of participants also limited the generalizability to diverse populations.

DISCLOSURES:

The study was supported by grants from the Australian National Health and Medical Research Council (NHMRC). Mr. Kifle disclosed receiving grants from the Australian NHMRC. Additional disclosures are noted in the original article.

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

TOPLINE:

MRI-derived abdominal adipose tissue is linked to chronic musculoskeletal pain in multiple sites. The association is stronger in women, suggesting sex differences in fat distribution and hormones.

METHODOLOGY:

• Researchers used data from the UK Biobank, a large population-based cohort study, to investigate the associations between MRI-measured abdominal adipose tissue and chronic musculoskeletal pain.
• A total of 32,409 participants (50.8% women; mean age, 55.0 ± 7.4 years) were included in the analysis, with abdominal MRI scans performed at two imaging visits.
• Pain in the neck/shoulder, back, hip, knee, or “all over the body” was assessed, and participants were categorized based on the number of chronic pain sites.
• Mixed-effects ordinal, multinomial, and logistic regression models were used to analyze the associations between visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and their ratio with chronic pain.

TAKEAWAY:

• According to the authors, there was a dose-response association between VAT, SAT, and their ratio with the number of chronic pain sites in both women and men.
• Higher levels of abdominal adipose tissue were associated with greater odds of reporting chronic pain in both sexes, with effect estimates being relatively larger in women.
• The researchers found that the VAT/SAT ratio was associated with the number of chronic pain sites and chronic pain in both sexes, reflecting differences in fat distribution and hormones.
• The study suggested that excessive abdominal adipose tissue may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain.

IN PRACTICE:

“Abdominal adipose tissue was associated with chronic musculoskeletal pain, suggesting that excessive and ectopic fat depositions may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain,” wrote the authors of the study.

SOURCE:

This study was led by Zemene Demelash Kifle, University of Tasmania Menzies Institute for Medical Research in Hobart, Australia. It was published online in Regional Anesthesia & Pain Medicine.

LIMITATIONS: 

The study’s limitations included the use of a pain questionnaire that did not assess pain severity, which limited the ability to examine the relationship between fat measures and pain severity. Additionally, MRI was conducted on only two occasions, which may have not captured patterns and fluctuations in chronic pain sites. The relatively small size of the imaging sample, compared with the original baseline sample limited the generalizability of the findings. The predominant White ethnicity of participants also limited the generalizability to diverse populations.

DISCLOSURES:

The study was supported by grants from the Australian National Health and Medical Research Council (NHMRC). Mr. Kifle disclosed receiving grants from the Australian NHMRC. Additional disclosures are noted in the original article.

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

TOPLINE:

MRI-derived abdominal adipose tissue is linked to chronic musculoskeletal pain in multiple sites. The association is stronger in women, suggesting sex differences in fat distribution and hormones.

METHODOLOGY:

• Researchers used data from the UK Biobank, a large population-based cohort study, to investigate the associations between MRI-measured abdominal adipose tissue and chronic musculoskeletal pain.
• A total of 32,409 participants (50.8% women; mean age, 55.0 ± 7.4 years) were included in the analysis, with abdominal MRI scans performed at two imaging visits.
• Pain in the neck/shoulder, back, hip, knee, or “all over the body” was assessed, and participants were categorized based on the number of chronic pain sites.
• Mixed-effects ordinal, multinomial, and logistic regression models were used to analyze the associations between visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and their ratio with chronic pain.

TAKEAWAY:

• According to the authors, there was a dose-response association between VAT, SAT, and their ratio with the number of chronic pain sites in both women and men.
• Higher levels of abdominal adipose tissue were associated with greater odds of reporting chronic pain in both sexes, with effect estimates being relatively larger in women.
• The researchers found that the VAT/SAT ratio was associated with the number of chronic pain sites and chronic pain in both sexes, reflecting differences in fat distribution and hormones.
• The study suggested that excessive abdominal adipose tissue may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain.

IN PRACTICE:

“Abdominal adipose tissue was associated with chronic musculoskeletal pain, suggesting that excessive and ectopic fat depositions may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain,” wrote the authors of the study.

SOURCE:

This study was led by Zemene Demelash Kifle, University of Tasmania Menzies Institute for Medical Research in Hobart, Australia. It was published online in Regional Anesthesia & Pain Medicine.

LIMITATIONS: 

The study’s limitations included the use of a pain questionnaire that did not assess pain severity, which limited the ability to examine the relationship between fat measures and pain severity. Additionally, MRI was conducted on only two occasions, which may have not captured patterns and fluctuations in chronic pain sites. The relatively small size of the imaging sample, compared with the original baseline sample limited the generalizability of the findings. The predominant White ethnicity of participants also limited the generalizability to diverse populations.

DISCLOSURES:

The study was supported by grants from the Australian National Health and Medical Research Council (NHMRC). Mr. Kifle disclosed receiving grants from the Australian NHMRC. Additional disclosures are noted in the original article.

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

MADRID — Night owls — individuals with late chronotypes — may be at an increased risk for type 2 diabetes (T2D), beyond the risks conferred by an unhealthy lifestyle, research presented at the annual meeting of the European Association for the Study of Diabetes suggested.

In the study, night owls were almost 50% more likely to develop T2D than those who went to sleep earlier.

“The magnitude of this risk was more than I expected, [although] residual confounding may have occurred,” said Jeroen van der Velde, PhD, Leiden University Medical Center in the Netherlands, who presented the study.

“Late chronotype has previously been associated with unhealthy lifestyle and overweight or obesity and, subsequently, cardiometabolic diseases,” he said in an interview. However, although the current study found that individuals with late chronotypes did indeed have larger waists and more visceral fat, “we (and others) believe that lifestyle cannot fully explain the relation between late chronotype and metabolic disorders.”

“In addition,” he noted, “previous studies that observed that late chronotype is associated with overweight or obesity mainly focused on body mass index [BMI]. However, BMI alone does not provide accurate information regarding fat distribution in the body. People with similar BMI may have different underlying fat distribution, and this may be more relevant than BMI for metabolic risk.”

The researchers examined associations between chronotype and BMI, waist circumference, visceral fat, liver fat, and the risk for T2D in a middle-aged population from the Netherlands Epidemiology of Obesity study. Among the 5026 participants, the mean age was 56 years, 54% were women, and mean BMI was 30.

Using data from the study, the study investigators calculated the midpoint of sleep (MPS) and divided participants into three chronotypes: Early MPS < 2:30 PM (20% of participants); intermediate MPS 2:30–4:00 PM (reference category; 60% of participants); and late MPS ≥ 4:00 PM (20% of participants). BMI and waist circumference were measured in all participants, and visceral fat and liver fat were measured in 1576 participants using MRI scans and MR spectroscopy, respectively.

During a median follow-up of 6.6 years, 225 participants were diagnosed with T2D. After adjustment for age, sex, education, physical activity, smoking, alcohol intake, diet quality, sleep quality and duration, and total body fat, participants with a late chronotype had a 46% increased risk for T2D.

Further, those with a late chronotype had 0.7 higher BMI, 1.9-cm larger waist circumference, 7 cm² more visceral fat, and 14% more liver fat.
 

Body Clock Out of Sync?

“Late chronotype was associated with increased ectopic body fat and with an increased risk of T2D independent of lifestyle factors and is an emerging risk factor for metabolic diseases,” the researchers concluded.

“A likely explanation is that the circadian rhythm or body clock in late chronotypes is out of sync with the work and social schedules followed by society,” Dr. van der Velde suggested. “This can lead to circadian misalignment, which we know can lead to metabolic disturbances and ultimately type 2 diabetes.”

Might trying to adjust chronotype earlier in life have an effect on risk?

“Chronotype, as measured via midpoint of sleep, does change a lot in the first 30 years or so in life,” he said. “After that it seems to stabilize. I suppose that if you adapt an intermediate or early chronotype around the age of 30 years, this will help to maintain an earlier chronotype later in life, although we cannot answer this from our study.”

Nevertheless, with respect to T2D risk, “chronotype is likely only part of the puzzle,” he noted.

“People with late chronotypes typically eat late in the evening, and this has also been associated with adverse metabolic effects. At this stage, we do not know if a person changes his/her chronotype that this will also lead to metabolic improvements. More research is needed before we can make recommendations regarding chronotype and timing of other lifestyle behaviors.”

Commenting on the study, Gianluca Iacobellis, MD, PhD, director of the University of Miami Hospital Diabetes Service, Coral Gables, Florida, said: “Interesting data. Altering the physiological circadian rhythm can affect the complex hormonal system — including cortisol, ghrelin, leptin, and serotonin — that regulates insulin sensitivity, glucose, and blood pressure control. The night owl may become more insulin resistant and therefore at higher risk of developing diabetes.”

Like Dr. van der Velde, he noted that “late sleep may be associated with night binging that can cause weight gain and ultimately obesity, further increasing the risk of diabetes.”

Dr. Iacobellis’s group recently showed that vital exhaustion, which is characterized by fatigue and loss of vigor, is associated with a higher cardiovascular risk for and markers of visceral adiposity.

“Abnormal circadian rhythms can be easily associated with vital exhaustion,” he said. Therefore, night owls with more visceral than peripheral fat accumulation might also be at higher cardiometabolic risk through that mechanism.

“However environmental factors and family history can play an important role too,” he added.

Regardless of the mechanisms involved, “preventive actions should be taken to educate teenagers and individuals at higher risk to have healthy sleep habits,” Dr. Iacobellis concluded.

No information regarding funding was provided; Dr. van der Velde and Dr. Iacobellis reported no conflicts of interest.

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

MADRID — Night owls — individuals with late chronotypes — may be at an increased risk for type 2 diabetes (T2D), beyond the risks conferred by an unhealthy lifestyle, research presented at the annual meeting of the European Association for the Study of Diabetes suggested.

In the study, night owls were almost 50% more likely to develop T2D than those who went to sleep earlier.

“The magnitude of this risk was more than I expected, [although] residual confounding may have occurred,” said Jeroen van der Velde, PhD, Leiden University Medical Center in the Netherlands, who presented the study.

“Late chronotype has previously been associated with unhealthy lifestyle and overweight or obesity and, subsequently, cardiometabolic diseases,” he said in an interview. However, although the current study found that individuals with late chronotypes did indeed have larger waists and more visceral fat, “we (and others) believe that lifestyle cannot fully explain the relation between late chronotype and metabolic disorders.”

“In addition,” he noted, “previous studies that observed that late chronotype is associated with overweight or obesity mainly focused on body mass index [BMI]. However, BMI alone does not provide accurate information regarding fat distribution in the body. People with similar BMI may have different underlying fat distribution, and this may be more relevant than BMI for metabolic risk.”

The researchers examined associations between chronotype and BMI, waist circumference, visceral fat, liver fat, and the risk for T2D in a middle-aged population from the Netherlands Epidemiology of Obesity study. Among the 5026 participants, the mean age was 56 years, 54% were women, and mean BMI was 30.

Using data from the study, the study investigators calculated the midpoint of sleep (MPS) and divided participants into three chronotypes: Early MPS < 2:30 PM (20% of participants); intermediate MPS 2:30–4:00 PM (reference category; 60% of participants); and late MPS ≥ 4:00 PM (20% of participants). BMI and waist circumference were measured in all participants, and visceral fat and liver fat were measured in 1576 participants using MRI scans and MR spectroscopy, respectively.

During a median follow-up of 6.6 years, 225 participants were diagnosed with T2D. After adjustment for age, sex, education, physical activity, smoking, alcohol intake, diet quality, sleep quality and duration, and total body fat, participants with a late chronotype had a 46% increased risk for T2D.

Further, those with a late chronotype had 0.7 higher BMI, 1.9-cm larger waist circumference, 7 cm² more visceral fat, and 14% more liver fat.
 

Body Clock Out of Sync?

“Late chronotype was associated with increased ectopic body fat and with an increased risk of T2D independent of lifestyle factors and is an emerging risk factor for metabolic diseases,” the researchers concluded.

“A likely explanation is that the circadian rhythm or body clock in late chronotypes is out of sync with the work and social schedules followed by society,” Dr. van der Velde suggested. “This can lead to circadian misalignment, which we know can lead to metabolic disturbances and ultimately type 2 diabetes.”

Might trying to adjust chronotype earlier in life have an effect on risk?

“Chronotype, as measured via midpoint of sleep, does change a lot in the first 30 years or so in life,” he said. “After that it seems to stabilize. I suppose that if you adapt an intermediate or early chronotype around the age of 30 years, this will help to maintain an earlier chronotype later in life, although we cannot answer this from our study.”

Nevertheless, with respect to T2D risk, “chronotype is likely only part of the puzzle,” he noted.

“People with late chronotypes typically eat late in the evening, and this has also been associated with adverse metabolic effects. At this stage, we do not know if a person changes his/her chronotype that this will also lead to metabolic improvements. More research is needed before we can make recommendations regarding chronotype and timing of other lifestyle behaviors.”

Commenting on the study, Gianluca Iacobellis, MD, PhD, director of the University of Miami Hospital Diabetes Service, Coral Gables, Florida, said: “Interesting data. Altering the physiological circadian rhythm can affect the complex hormonal system — including cortisol, ghrelin, leptin, and serotonin — that regulates insulin sensitivity, glucose, and blood pressure control. The night owl may become more insulin resistant and therefore at higher risk of developing diabetes.”

Like Dr. van der Velde, he noted that “late sleep may be associated with night binging that can cause weight gain and ultimately obesity, further increasing the risk of diabetes.”

Dr. Iacobellis’s group recently showed that vital exhaustion, which is characterized by fatigue and loss of vigor, is associated with a higher cardiovascular risk for and markers of visceral adiposity.

“Abnormal circadian rhythms can be easily associated with vital exhaustion,” he said. Therefore, night owls with more visceral than peripheral fat accumulation might also be at higher cardiometabolic risk through that mechanism.

“However environmental factors and family history can play an important role too,” he added.

Regardless of the mechanisms involved, “preventive actions should be taken to educate teenagers and individuals at higher risk to have healthy sleep habits,” Dr. Iacobellis concluded.

No information regarding funding was provided; Dr. van der Velde and Dr. Iacobellis reported no conflicts of interest.

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

MADRID — Night owls — individuals with late chronotypes — may be at an increased risk for type 2 diabetes (T2D), beyond the risks conferred by an unhealthy lifestyle, research presented at the annual meeting of the European Association for the Study of Diabetes suggested.

In the study, night owls were almost 50% more likely to develop T2D than those who went to sleep earlier.

“The magnitude of this risk was more than I expected, [although] residual confounding may have occurred,” said Jeroen van der Velde, PhD, Leiden University Medical Center in the Netherlands, who presented the study.

“Late chronotype has previously been associated with unhealthy lifestyle and overweight or obesity and, subsequently, cardiometabolic diseases,” he said in an interview. However, although the current study found that individuals with late chronotypes did indeed have larger waists and more visceral fat, “we (and others) believe that lifestyle cannot fully explain the relation between late chronotype and metabolic disorders.”

“In addition,” he noted, “previous studies that observed that late chronotype is associated with overweight or obesity mainly focused on body mass index [BMI]. However, BMI alone does not provide accurate information regarding fat distribution in the body. People with similar BMI may have different underlying fat distribution, and this may be more relevant than BMI for metabolic risk.”

The researchers examined associations between chronotype and BMI, waist circumference, visceral fat, liver fat, and the risk for T2D in a middle-aged population from the Netherlands Epidemiology of Obesity study. Among the 5026 participants, the mean age was 56 years, 54% were women, and mean BMI was 30.

Using data from the study, the study investigators calculated the midpoint of sleep (MPS) and divided participants into three chronotypes: Early MPS < 2:30 PM (20% of participants); intermediate MPS 2:30–4:00 PM (reference category; 60% of participants); and late MPS ≥ 4:00 PM (20% of participants). BMI and waist circumference were measured in all participants, and visceral fat and liver fat were measured in 1576 participants using MRI scans and MR spectroscopy, respectively.

During a median follow-up of 6.6 years, 225 participants were diagnosed with T2D. After adjustment for age, sex, education, physical activity, smoking, alcohol intake, diet quality, sleep quality and duration, and total body fat, participants with a late chronotype had a 46% increased risk for T2D.

Further, those with a late chronotype had 0.7 higher BMI, 1.9-cm larger waist circumference, 7 cm² more visceral fat, and 14% more liver fat.
 

Body Clock Out of Sync?

“Late chronotype was associated with increased ectopic body fat and with an increased risk of T2D independent of lifestyle factors and is an emerging risk factor for metabolic diseases,” the researchers concluded.

“A likely explanation is that the circadian rhythm or body clock in late chronotypes is out of sync with the work and social schedules followed by society,” Dr. van der Velde suggested. “This can lead to circadian misalignment, which we know can lead to metabolic disturbances and ultimately type 2 diabetes.”

Might trying to adjust chronotype earlier in life have an effect on risk?

“Chronotype, as measured via midpoint of sleep, does change a lot in the first 30 years or so in life,” he said. “After that it seems to stabilize. I suppose that if you adapt an intermediate or early chronotype around the age of 30 years, this will help to maintain an earlier chronotype later in life, although we cannot answer this from our study.”

Nevertheless, with respect to T2D risk, “chronotype is likely only part of the puzzle,” he noted.

“People with late chronotypes typically eat late in the evening, and this has also been associated with adverse metabolic effects. At this stage, we do not know if a person changes his/her chronotype that this will also lead to metabolic improvements. More research is needed before we can make recommendations regarding chronotype and timing of other lifestyle behaviors.”

Commenting on the study, Gianluca Iacobellis, MD, PhD, director of the University of Miami Hospital Diabetes Service, Coral Gables, Florida, said: “Interesting data. Altering the physiological circadian rhythm can affect the complex hormonal system — including cortisol, ghrelin, leptin, and serotonin — that regulates insulin sensitivity, glucose, and blood pressure control. The night owl may become more insulin resistant and therefore at higher risk of developing diabetes.”

Like Dr. van der Velde, he noted that “late sleep may be associated with night binging that can cause weight gain and ultimately obesity, further increasing the risk of diabetes.”

Dr. Iacobellis’s group recently showed that vital exhaustion, which is characterized by fatigue and loss of vigor, is associated with a higher cardiovascular risk for and markers of visceral adiposity.

“Abnormal circadian rhythms can be easily associated with vital exhaustion,” he said. Therefore, night owls with more visceral than peripheral fat accumulation might also be at higher cardiometabolic risk through that mechanism.

“However environmental factors and family history can play an important role too,” he added.

Regardless of the mechanisms involved, “preventive actions should be taken to educate teenagers and individuals at higher risk to have healthy sleep habits,” Dr. Iacobellis concluded.

No information regarding funding was provided; Dr. van der Velde and Dr. Iacobellis reported no conflicts of interest.

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