Comparison of Body Composition Changes With Weight Loss Interventions
Part of paid clinical trials in Nashville, Tennessee.
- Sponsor
- Vanderbilt University Medical Center
- Study ID
- NCT07115069
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- GLP-1 receptor agonist — DRUGAny FDA-approved GLP-1 receptor agonist
- Gastric Bypass Surgery (laparoscopic) — PROCEDUREPatients undergo laparoscopic gastric bypass with a roux limb between 75 - 150 cm and biliopancreatic limb between 50 - 150 cm as determined by the primary surgeon.
- Gastric Bypass Surgery (robotic) — PROCEDUREPatients undergo robotic gastric bypass with a roux limb between 75 - 150 cm and biliopancreatic limb between 50 - 150 cm as determined by the primary surgeon.
Study Details
This study is being done to compare the effects of a newer class of weight loss medications to weight loss surgery on the body's muscle, metabolism, and side effects over time. People with severe obesity often lose weight using either medications like GLP-1 receptor agonists (such as semaglutide or tirzepatide) or by having bariatric surgery, such as gastric bypass. While both approaches can lead to weight loss, they may affect the body in different ways. The investigators are inviting adult patients who are planning to either start one of these weight loss medications or undergo gastric bypass surgery to join this study. Participants will be asked to complete four body composition scans (called DXA scans) over the course of a year-at the beginning of the study and again at 3, 6, and 12 months. These scans will help us measure changes in fat and muscle. Participants will also complete surveys and provide information on side effects, such as nausea or fatigue, that may affect their eating or activity levels. The investigators' goal is to better understand how different weight loss treatments impact not just weight, but also muscle mass, energy levels, and side effects. This information may help doctors and patients choose the most appropriate treatment in the future.
Key Dates
- Start date
- Aug 9, 2025
- Status verified
- Aug 2025
- Primary completion
- Sep 30, 2026
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 60 participants (estimated)
Arms
- Arm: GLP-1 Receptor Agonists ArmPatient recieving Glucagon Like Peptide 1 Receptor Agonists (GLP1RA) or incretin polyagonists.
- Arm: Gastric Bypass surgery (laparoscopic)Patients undergoing gastric bypass laparoscopically
- Arm: Gastric Bypass surgery (robotic)Patients undergoing Gastric Bypass surgery robotically
Primary Outcome Measure
Skeletal Muscle Loss [ Time Frame: 6 months ]
Central Contacts
- Jason M Samuels, MD2142891373
- Jason Samuels2142891373
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | - |
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