Impact GLP-1 Agonists Following Bariatric

Status

Recruiting

Phase

Phase 4

Enrollment

150 participants (estimated)

Sponsor

University of Missouri-Columbia · Other

Design

Randomized · Open label (no masking)

Countries

1 country

United States

Start

1 Feb 2024

Primary completion

Jul 2028 (estimated)

Completion

Jul 2030 (estimated)

First posted

15 Nov 2023

Last update posted

21 Oct 2026

Conditions

Morbid Obesity · Metabolic Syndrome · Diabetes Mellitus · Hypertension · Obstructive Sleep Apnea of Adult

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.

• Active comparator

  GLP-1 Agonist Group

  This cohort will consist of patients undergoing bariatric surgery who are currently receiving a GLP-1 Agonists for weight loss and/or diabetes management, that will be maintained on their preoperative dose of GLP-1 agonist following their bariatric surgery. This includes semaglutide, tirzepitide, among others. The dosage will be variable, but will be the same dose the patient is on prior to the bariatric surgery. Duration will be one of the aims of the study.

• No intervention

  Non-GLP-1 Agonist Group

  This cohort will consist of patients undergoing bariatric surgery who are currently receiving a GLP-1 Agonist for weight loss and/or diabetes management that will be required to stop taking their preoperative dose of GLP-1 agonist following their bariatric surgery. Dosage preoperative will be variable based on what the patient is currently taking, as well as the medication being taken.

1. Effect of GLP1-RA on weight loss

   Time frame · 6 months

   Registry description

   To investigate the effects of GLP1-RAs on weight loss reflected as change in BMI (kg per meter sq) in patients undergoing metabolic surgery

2. Effect of GLP1-RA on circulating bile acids and metabolites

   Time frame · 6 months

   Registry description

   Determine the impact of GLP1-RA on circulating bile acids and other metabolites

3. Effector of GLP1-RA on gut microbiome diversity

   Time frame · 6 months

   Registry description

   To determine the impact of GLP1-RAs after bariatric surgery on changes in the gut microbiome

4. Effect of GLP1-RA on satiety and hunger

   Time frame · 6 months

   Registry description

   To assess the impact of GLP-1 agonists on satiety and hunger in patients who undergo metabolic surgery. Scale will be a validated scoring system, "Daily Eats Questionnaire," with scores ranging from 0-10, with a 0 indicating no hunger, and 10 indicating extreme hunger

5. Effect of GLP1-RA on Glycemic control

   Time frame · 6 months

   Registry description

   HGBA1C levels will be measured at 3 and 6 months after surgery to determine if HGBA1C drops more in patients maintained on GLP1-RA