Impact GLP-1 Agonists Following Bariatric

Launched by UNIVERSITY OF MISSOURI-COLUMBIA · Nov 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called GLP-1 receptor agonists (GLP1-RAs) on patients undergoing weight loss surgery. GLP1-RAs help control blood sugar levels and can aid in weight loss. The trial will compare the results of patients who continue taking this medication after their surgery versus those who stop taking it. Researchers want to see how these different approaches affect weight loss, blood sugar control, and other health markers, as well as any side effects experienced.

To be eligible for this trial, participants must be at least 18 years old, have a body mass index (BMI) between 30 and 80, and be planning to undergo specific types of weight loss surgery, such as gastric bypass or sleeve gastrectomy. Participants will be randomly assigned to either continue or stop their GLP1-RA medication after surgery. They can expect to have blood samples taken before and after their surgery and will help researchers gather important data on how the medication impacts their health outcomes. This study aims to provide valuable insights that could help others with obesity and diabetes make informed decisions about their treatment options.

Gender

ALL

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