Actively Recruiting

Age: 21Years - 65Years
All Genders
NCT07115069

Comparison of Body Composition Changes With Weight Loss Interventions

Led by Vanderbilt University Medical Center · Updated on 2025-10-21

60

Participants Needed

1

Research Sites

72 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Comparison of Body Composition Changes With Weight Loss Interventions

Who Can Participate

Age: 21Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • BMI between 35 and 60
  • Planning primary weight loss surgery (gastric bypass) or medical weight loss with GLP1 receptor agonists (Semaglutide or Tirzepatide)
  • Age between 21 and 65 years
Not Eligible

You will not qualify if you...

  • Revisional gastric bypass surgery (e.g., sleeve to bypass)
  • Less than 3 months of continuous GLP1 receptor agonist use
  • Type 1 diabetes
  • History of myocardial infarction
  • Unstable angina or heart failure
  • Stroke
  • Solid organ transplantation
  • Systemic glucocorticoid use in the prior 28 days
  • Uncontrolled hypertension (systolic > 150 or diastolic > 90)
  • Untreated hyperthyroidism
  • Chronic kidney disease with estimated glomerular filtration rate less than 60

AI-Screening

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Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

J

Jason M Samuels, MD

CONTACT

J

Jason Samuels

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Comparison of Body Composition Changes With Weight Loss Interventions | DecenTrialz