Effects of GLP-1 Agonists After Bariatric Surgery
Biometabolic Impact of Continuation of GLP-1 Agonists Following Bariatric
This study is testing whether continuing or stopping a specific diabetes medication after weight loss surgery helps improve health for people who have had gastric bypass or sleeve gastrectomy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT06132477 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of continuing or discontinuing GLP-1 receptor agonist therapy in patients undergoing bariatric surgery, specifically gastric bypass or sleeve gastrectomy. The study involves randomizing participants who are already on GLP-1 agonists and comparing their outcomes based on different surgical techniques and lengths of biliopancreatic limb. Researchers will collect serum and stool samples to analyze changes in bile acid synthesis and gut microbiome content, aiming to understand the combined effects of GLP-1 therapy and surgical intervention on metabolic health. The trial is conducted at the University of Missouri-Columbia and has received IRB approval.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing bariatric surgery and are currently taking a GLP-1 agonist.
Not a fit: Patients who are not taking a GLP-1 agonist or those who do not meet the surgical eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance weight loss and metabolic health outcomes for patients undergoing bariatric surgery.
How similar studies have performed: While the combined effects of GLP-1 agonists and bariatric surgery have been studied to a limited extent, this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Columbia, Missouri
- University of Missouri Hospital — Columbia, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Wheeler, MD — University of Missouri-Columbia
- Study coordinator: Jennifer Randolph
- Email: muresearchirb@missouri.edu
- Phone: 573-882-4387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.