Recruiting

GLP-1 Agonists

Sponsor:

University of Missouri-Columbia

Code:

NCT06132477

Conditions

Morbid Obesity

Metabolic Syndrome

Diabetes Mellitus

Hypertension

Obstructive Sleep Apnea of Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GLP-1 receptor agonist

Study Details

Brief 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.

Conditions

Morbid Obesity

Metabolic Syndrome

Diabetes Mellitus

Hypertension

Obstructive Sleep Apnea of Adult

Study ID

NCT06132477

Start date

Feb 1, 2024

Status verified date

Jul, 2025

Completion date

Jul, 2030

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Greater than 18 years of age
2. Participation in care by one of the surgeons at MU Health Care
3. Undergoing surgical weight loss through the Weight Management and Metabolic Center
4. Body mass index of 30-80 kg/m2
5. Meet insurance criteria, as set forth by the patient's insurance policy, to qualify for coverage for weight loss surgery or as a self-pay patient for the weight loss procedure
6. Planned laparoscopic Roux-en-Y gastric bypass, sleeve gastrectomy, revisional weight loss surgery, or duodenal switch or modification of. If patients are not willing to be randomized they will not be enrolled as randomized but can still participate having samples collected.
7. Willingness to have blood collected before and after surgical procedure at defined points or at minimum have clinical data collected.
8. Willingness to have clinical data entered into a prospective database
9. Additional specimens collected as stated in the protocol will be offered but collection not mandated.

5\. Taking a GLP-1 agonist as part of their routine medical care apart from any planned surgical procedure. The current standard of care regarding continuation or discontinuation of GLP-1 agonists has not been established and is at the discretion of members of the patient's medical team but to be included the patient and medical care team must be willing to continue or discontinue the GLP-1 agonist after surgery depending on the randomized group.

Exclusion Criteria:

1. Pregnant patient
2. Desire to not participate
3. Age less than 18
4. Patient fails to fulfill insurance mandated criteria and is not interested in paying cash for their procedure
5. Not taking a GLP-1 agonist as part of standard medical care
6. Unwilling to follow-up at required postoperative visits
7. Unwilling to stop GLP-1 agonist if randomized into group to stop GLP-1 agonist or unwilling to continue the GLP-1 agonist if randomized into that respective group. If chooses to continue or discontinue the medication apart from randomization the patient can still participate as a non-randomized participant

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

GLP-1 receptor agonist

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

Primary outcome measure

  • Effect of GLP1-RA on weight loss [ Time Frame: 6 months ]
  • Effect of GLP1-RA on circulating bile acids and metabolites [ Time Frame: 6 months ]
  • Effector of GLP1-RA on gut microbiome diversity [ Time Frame: 6 months ]
  • Effect of GLP1-RA on satiety and hunger [ Time Frame: 6 months ]
  • Effect of GLP1-RA on Glycemic control [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

University of Missouri Hospital

Recruiting

Columbia, Missouri, United States, 65201

Contacts

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Jan 22, 2026

Last verified

Jul, 2025

Keywords

  • glp-1 agonist
  • Morbid Obesity
  • Bariatric Surgery
  • Metabolic syndrome
  • Diabetes Mellitus
  • Hypertension
  • Obstructive Sleep Apnea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2026-01-22.