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Comparison of Body Composition Changes With Weight Loss Interventions

NCT07115069 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-10-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

GLP-1 receptor agonist

Any FDA-approved GLP-1 receptor agonist

PROCEDURE

Gastric Bypass Surgery (laparoscopic)

Patients 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.

PROCEDURE

Gastric Bypass Surgery (robotic)

Patients 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.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Jason M Samuels, MD · Vanderbilt University Medical Center

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-09
Primary Completion
2026-09-30
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07115069 on ClinicalTrials.gov