NCT06132477 Impact GLP-1 Agonists Following Bariatric
| NCT ID | NCT06132477 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Missouri-Columbia |
| Condition | Morbid Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150 participants in total. It began in 2024-02-01 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Andrew Wheeler, MD
PRINCIPAL INVESTIGATOR
University of Missouri-Columbia
Frequently Asked Questions
Who can join the NCT06132477 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Morbid Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06132477 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06132477 currently recruiting?
Yes, NCT06132477 is actively recruiting participants. Contact the research team at randolphjl@health.missouri.edu for enrollment information.
Where is the NCT06132477 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT06132477 clinical trial?
NCT06132477 is sponsored by University of Missouri-Columbia. The principal investigator is Andrew Wheeler, MD at University of Missouri-Columbia. The trial plans to enroll 150 participants.
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