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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 65
View:

• BMI ≥35 and ≤60

• Primary weight loss surgery (gastric bypass), or

• Medical weight loss with GLP1RAs (Semaglutide or Tirzepatide)

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Jason M Samuels, MD
jason.m.samuels@vumc.org
2142891373
Backup
Jason Samuels
jason.m.samuels@vumc.org
2142891373
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2027-01
Participants
Target number of participants: 60
Treatments
GLP-1 Receptor Agonists Arm
Patient recieving Glucagon Like Peptide 1 Receptor Agonists (GLP1RA) or incretin polyagonists.
Gastric Bypass surgery (laparoscopic)
Patients undergoing gastric bypass laparoscopically
Gastric Bypass surgery (robotic)
Patients undergoing Gastric Bypass surgery robotically
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov