RECRUITING

Comparison of Body Composition Changes With Weight Loss Interventions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-09
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07115069

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.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * BMI ≥35 and ≤60
  2. * Primary weight loss surgery (gastric bypass), or
  3. * Medical weight loss with GLP1RAs (Semaglutide or Tirzepatide)
  1. * Revisional gastric bypass (e.g. sleeve to bypass),
  2. * \<3 months of continuous use of GLP1RA,
  3. * Type 1 Diabetes,
  4. * Myocardial Infarction,
  5. * Unstable Angina or Heart Failure,
  6. * Stroke
  7. * Solid organ transplantation,
  8. * Systemic glucocorticoid prior 28 days,
  9. * Uncontrolled Hypertension, (Systolic \> 150, Diastolic \> 90)
  10. * Untreated Hyperthyroidism
  11. * Chronic Kidney Disease (EGFR \< 60).

Contacts and Locations

Study Contact

Jason M Samuels, MD
CONTACT
2142891373
jason.m.samuels@vumc.org
Jason Samuels
CONTACT
2142891373
jason.m.samuels@vumc.org

Principal Investigator

Jason M Samuels, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09
Study Completion Date2027-01

Study Record Updates

Study Start Date2025-09
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • obesity
  • GLP-1 receptor agonist
  • gastric bypass surgery
  • bariatric surgery
  • incretin
  • glucagon like peptide 1 receptor agonist
  • robotic surgery

Additional Relevant MeSH Terms

  • Obesity