Actively Recruiting
Impact GLP-1 Agonists Following Bariatric
Led by University of Missouri-Columbia · Updated on 2026-01-22
150
Participants Needed
1
Research Sites
334 weeks
Total Duration
On this page
Sponsors
U
University of Missouri-Columbia
Lead Sponsor
A
American Society for Metabolic and Bariatric Surgery
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact GLP-1 Agonists Following Bariatric
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Receiving care by a surgeon at MU Health Care
- Undergoing surgical weight loss at the Weight Management and Metabolic Center
- Body mass index between 30 and 80 kg/m2
- Meeting insurance criteria or self-paying for weight loss surgery
- Planned laparoscopic Roux-en-Y gastric bypass, sleeve gastrectomy, revisional surgery, or duodenal switch
- Taking a GLP-1 agonist as part of routine medical care
- Willing to have blood samples collected before and after surgery or have clinical data collected
- Willing to have clinical data entered into a prospective database
- Willing to provide additional specimens as offered by the study
You will not qualify if you...
- Pregnant patients
- Patients under 18 years of age
- Patients who do not meet insurance criteria and are unwilling to pay cash for surgery
- Not currently taking a GLP-1 agonist as part of standard care
- Unwilling to attend required postoperative follow-up visits
- Unwilling to follow the study instructions to continue or stop GLP-1 agonist according to randomization
- Patients who decline to participate
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Missouri Hospital
Columbia, Missouri, United States, 65201
Actively Recruiting
Research Team
J
Jennifer Randolph
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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