Clinical Trial

Comparison of Body Composition Changes With Weight Loss Interventions

Study acronym: REFORM
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-08-03; most recent amendment 2026-07-11.
Status change: Recruiting → Active, Not Recruiting 2026-07-11
Status change: Not Yet Recruiting → Recruiting 2025-08-20
Trial Details
NCT Number NCT07115069
Lead Sponsor Vanderbilt University Medical Center
Conditions Obesity
Enrollment 60 participants
Start Date 2025-08-09
Primary Completion 2027-06 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-14