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Clinical Trial NCT06132477 for Morbid Obesity, Metabolic Syndrome, Diabetes Mellitus, Hypertension, Obstructive Sleep Apnea of Adult is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of Missouri-ColumbiaImpact GLP-1 Agonists Following Bariatric Phase 4 150 Microbiome Randomized
Clinical Trial NCT06132477 is designed to study Treatment for Morbid Obesity, Metabolic Syndrome, Diabetes Mellitus, Hypertension, Obstructive Sleep Apnea of Adult. It is a Phase 4 interventional study that is recruiting, having started on 1 February 2024, with plans to enroll 150 participants. Led by University of Missouri-Columbia, it is expected to complete by 1 July 2030. The latest data from ClinicalTrials.gov was last updated on 22 January 2026.
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. Bariat...Show More
Detailed Description
Preliminary Work To date we have established a randomized controlled clinical trial where we are comparing groups of patients with variable lengths of biliopancreatic limb lengths during gastric bypass. VSG patients serve as a control surgical group, and we have gathered both serum and stool in over 200 patients. We have collaborated with both the institutional metagenomics and proteomics centers to process samples a...Show More
Official Title
Biometabolic Impact of Continuation of GLP-1 Agonists Following Bariatric
Conditions
Morbid ObesityMetabolic SyndromeDiabetes MellitusHypertensionObstructive Sleep Apnea of AdultPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 2098885
NCT ID Number
Start Date (Actual)
2024-02-01
Last Update Posted
2026-01-22
Completion Date (Estimated)
2030-07
Enrollment (Estimated)
150
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
glp-1 agonist
Morbid Obesity
Bariatric Surgery
Metabolic syndrome
Diabetes Mellitus
Hypertension
Obstructive Sleep Apnea
Morbid Obesity
Bariatric Surgery
Metabolic syndrome
Diabetes Mellitus
Hypertension
Obstructive Sleep Apnea
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorGLP-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. Dur...Show More | GLP-1 receptor agonist Randomized to continue or discontinue GLP-1 receptor agonists after bariatric surgery |
No InterventionNon-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. | N/A |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Effect of GLP1-RA on weight loss | To investigate the effects of GLP1-RAs on weight loss reflected as change in BMI (kg per meter sq) in patients undergoing metabolic surgery | 6 months |
Effect of GLP1-RA on circulating bile acids and metabolites | Determine the impact of GLP1-RA on circulating bile acids and other metabolites | 6 months |
Effector of GLP1-RA on gut microbiome diversity | To determine the impact of GLP1-RAs after bariatric surgery on changes in the gut microbiome | 6 months |
Effect of GLP1-RA on satiety and hunger | 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 | 6 months |
Effect of GLP1-RA on Glycemic control | HGBA1C levels will be measured at 3 and 6 months after surgery to determine if HGBA1C drops more in patients maintained on GLP1-RA | 6 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Greater than 18 years of age
- Participation in care by one of the surgeons at MU Health Care
- Undergoing surgical weight loss through the Weight Management and Metabolic Center
- Body mass index of 30-80 kg/m2
- 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
- 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.
- Willingness to have blood collected before and after surgical procedure at defined points or at minimum have clinical data collected.
- Willingness to have clinical data entered into a prospective database
- 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.
- Pregnant patient
- Desire to not participate
- Age less than 18
- Patient fails to fulfill insurance mandated criteria and is not interested in paying cash for their procedure
- Not taking a GLP-1 agonist as part of standard medical care
- Unwilling to follow-up at required postoperative visits
- 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
University of Missouri-Columbia94 active studies to exploreAmerican Society for Metabolic and Bariatric SurgeryStudy Responsible Party
Andrew Wheeler, Principal Investigator, Assistant Professor of Surgery, University of Missouri-Columbia
Study Central Contact
Contact: Jennifer Randolph, 573-882-4387, [email protected]
1 Study Locations in 1 Countries
Missouri
University of Missouri Hospital, Columbia, Missouri, 65201, United States
Andrew Wheeler, MD, Contact, 573-882-5609, [email protected]
Milot Thaqi, MD, Contact, 7086421788, [email protected]
Recruiting