Effects of GLP-1 Agonists After Bariatric Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Missouri Hospital
  Columbia, Missouri, United States Recruiting

Study contacts

• Principal investigator: Andrew Wheeler, MD — University of Missouri-Columbia
• Study coordinator: Jennifer Randolph, RN
• Email: randolphjl@health.missouri.edu
• Phone: 573-882-4387

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.