Status:
RECRUITING
Impact GLP-1 Agonists Following Bariatric
Lead Sponsor:
University of Missouri-Columbia
Collaborating Sponsors:
American Society for Metabolic and Bariatric Surgery
Conditions:
Morbid Obesity
Metabolic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 bypas...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06132477
Start Date
February 1 2024
End Date
July 1 2030
Last Update
August 5 2025
Active Locations (1)
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1
University of Missouri Hospital
Columbia, Missouri, United States, 65201