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Search / Trial NCT07115069

Comparison of Body Composition Changes With Weight Loss Interventions

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Aug 3, 2025

Trial Information

Current as of August 19, 2025

Not yet recruiting

Keywords

Obesity Glp 1 Receptor Agonist Gastric Bypass Surgery Bariatric Surgery Incretin Glucagon Like Peptide 1 Receptor Agonist Robotic Surgery

ClinConnect Summary

This clinical trial is studying how two common treatments for severe obesity—weight loss medications called GLP-1 receptor agonists (like semaglutide or tirzepatide) and weight loss surgery (specifically gastric bypass)—affect the body over time. Researchers want to learn not just about how much weight people lose, but also how these treatments impact muscle, metabolism (how your body uses energy), and possible side effects like nausea or tiredness. Understanding these differences can help doctors and patients decide which treatment might work best for each person.

Adults with a body mass index (BMI) between 35 and 60 who are planning to start either one of these medications or have gastric bypass surgery may be eligible to join. If you take part, you’ll have four special body scans over one year to measure changes in fat and muscle—once before starting treatment, and then at 3, 6, and 12 months after. You’ll also fill out surveys about any side effects you experience that might affect your eating or daily activities. People with certain health conditions, like type 1 diabetes or recent heart problems, would not be able to join. This study is not yet recruiting, but it aims to provide helpful information for those considering different weight loss options.

Gender

ALL

Eligibility criteria

  • 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).

About Vanderbilt University Medical Center

Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.

Locations

Patients applied

0 patients applied

Trial Officials

Jason M Samuels, MD

Principal Investigator

Vanderbilt University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported