Conduct of the REsponses in Function and Outcomes From RYGB vs. Medication Study (REFORM) Study by Research Coordinators
Vanderbilt University Medical Center
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.
Description
Patients are benefiting from landmark advancements in obesity treatments with the advent of Glucagon-like Peptide 1 Receptor agonists (GLP1RA) such as semaglutide and tirzepatide, which achieve weight loss of 15-20% in clinical trials.2,4,21 However, numerous questions surround the safety and efficacy of GLP1RAs compared to established surgical interventions. Minimally Invasive gastric bypass (GB) remains the benchmark for obesity treatments, with superior weight loss of 25-35%, and an extensive body of literature demonstrating long-term safety and efficacy, with rare complications and dramati…
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- Not specified
Inclusion Criteria: * BMI ≥35 and ≤60 * Primary weight loss surgery (gastric bypass), or * Medical weight loss with GLP1RAs (Semaglutide or Tirzepatide) Exclusion Criteria: * 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).
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.
Location
- Vanderbilt University Medical CenterNashville, Tennessee