NCT07115069Active, not recruiting
Comparison of Body Composition Changes With Weight Loss Interventions
Conduct of the REsponses in Function and Outcomes From RYGB vs. Medication Study (REFORM) Study by Research Coordinators
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 25 Jul 2025
- Start date
- 9 Aug 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Obesity
- NCT number
- NCT07115069
What you commit to
- Study type: Observational
- Planned participants: 60
- From 9 Aug 2025 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Solid organ transplantation,
- Systemic glucocorticoid prior 28 days,
Other illness
- Type 1 Diabetes,
- Myocardial Infarction,
- Unstable Angina or Heart Failure,
- Stroke
- Uncontrolled Hypertension, (Systolic \> 150, Diastolic \> 90)
Lab values
- Chronic Kidney Disease (EGFR \< 60).
Other
- Revisional gastric bypass (e.g. sleeve to bypass),
- \<3 months of continuous use of GLP1RA,
- Untreated Hyperthyroidism
Who the study is looking for
- BMI ≥35 and ≤60
- Primary weight loss surgery (gastric bypass), or
- Medical weight loss with GLP1RAs (Semaglutide or Tirzepatide)
Age in the registry: 21 years to 65 years · Sex: All
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.