RECRUITING

Comparison of Body Composition Changes With Weight Loss Interventions

Description

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

Study Overview

Study Details

Study overview

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.

Conduct of the REsponses in Function and Outcomes From RYGB vs. Medication Study (REFORM) Study by Research Coordinators

Comparison of Body Composition Changes With Weight Loss Interventions

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

21 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt University Medical Center,

Jason M Samuels, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

2027-01