RecruitingPhase 4NCT06132477

Impact GLP-1 Agonists Following Bariatric

Biometabolic Impact of Continuation of GLP-1 Agonists Following Bariatric


Sponsor

University of Missouri-Columbia

Enrollment

150 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Glucagon-like peptide 1 (GLP-1) is a hormone that helps regulate blood glucose levels through improved insulin sensitivity and release of insulin from the pancreas, control hunger, induce satiety and plays a role in the metabolic health of a person. GLP-1 receptor agonists (GLP1-RAs) have been shown to be effective in achieving weight loss in patients with type 2 diabetes while improving blood glucose control. Bariatric surgical procedures have been shown to be effective in treating obesity as well as superior to best medical therapy for treatment of diabetes not just through restriction of calories but also through a positive impact in modifications of gut hormones, changes in circulating bile acids, modifications in the gut microflora as well as other undefined mechanisms. The combined benefits of GLP1-RAs with bariatric surgery have only been studied to a limited effect. In this randomized trial, the effects of continuation or discontinuation of GLP1-RA therapy in patients undergoing bariatric surgery will be determined. We will compare changes in weight, metabolic determinants including circulating bile acids and gut microbiome, psychological determinants of eating behavior, and adverse side effects in patients who continue vs discontinue therapy. Given differences in metabolic and clinical outcomes in patients undergoing vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB), both surgical groups will be examined. The study will be conducted at a high volume bariatric surgical program where patients will undergo randomization at the time of final clinic visit prior to surgery to continue or discontinue GLP1-RA. It is hypothesized that participants who continue GLP1-RA therapy after bariatric surgery will lose more weight with improved blood glucose control than those who discontinue therapy. Furthermore, changes in gut microbiome and circulating bile acids, known determinants of metabolic health, will be modified to a differential extent in those who are on GLP1-RAs vs those where GLP1-RAs are discontinued. Understanding the role these medications play in not only clinical outcomes after metabolic surgery but potential metabolic mechanisms by which surgery improves patient's metabolic health could help people with obesity and type 2 diabetes make informed decisions about their treatment options as well as advise providers on the continuation of these medications in the perioperative and postoperative period.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether continuing or stopping GLP-1 agonist medications (like semaglutide/Ozempic or liraglutide) after bariatric (weight loss) surgery affects outcomes such as weight loss, blood sugar control, and overall health. GLP-1 drugs are increasingly common for weight management, but it's unclear whether they help or are even necessary after surgery. **You may be eligible if...** - You are over 18 years old - You are having bariatric surgery (gastric bypass, sleeve gastrectomy, duodenal switch, or revision surgery) - You have a BMI between 30 and 80 - You are currently taking a GLP-1 agonist as part of your regular medical care - You meet insurance criteria for surgery or are paying out of pocket **You may NOT be eligible if...** - You are pregnant - You are not currently taking a GLP-1 agonist - You are unwilling to follow the required post-surgery visits - You are unwilling to either continue or stop the GLP-1 medication as assigned by the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGLP-1 receptor agonist

Randomized to continue or discontinue GLP-1 receptor agonists after bariatric surgery


Locations(1)

University of Missouri Hospital

Columbia, Missouri, United States

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NCT06132477


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