RecruitingNCT07115069

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


Sponsor

Vanderbilt University Medical Center

Enrollment

60 participants

Start Date

Aug 9, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Inclusion Criteria3

  • BMI ≥35 and ≤60
  • Primary weight loss surgery (gastric bypass), or
  • Medical weight loss with GLP1RAs (Semaglutide or Tirzepatide)

Exclusion Criteria11

  • Revisional gastric bypass (e.g. sleeve to bypass),
  • <3 months of continuous use of GLP1RA,
  • Type 1 Diabetes,
  • Myocardial Infarction,
  • Unstable Angina or Heart Failure,
  • Stroke
  • Solid organ transplantation,
  • Systemic glucocorticoid prior 28 days,
  • Uncontrolled Hypertension, (Systolic > 150, Diastolic > 90)
  • Untreated Hyperthyroidism
  • Chronic Kidney Disease (EGFR < 60).

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Interventions

DRUGGLP-1 receptor agonist

Any FDA-approved GLP-1 receptor agonist

PROCEDUREGastric 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.

PROCEDUREGastric 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.


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT07115069


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