Clinical trial

Comparison of Body Composition Changes With Weight Loss Interventions

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07115069

Active, not recruitingNot applicableObservational

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 65 Years

SexAll

Healthy volunteersNot listed

ConditionObesity

Full registry 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).

Treatments and study arms

GLP-1 receptor agonist

Drug

Any FDA-approved GLP-1 receptor agonist

Gastric Bypass Surgery (laparoscopic)

Procedure

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.

Gastric Bypass Surgery (robotic)

Procedure

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.

Primary outcomes

Skeletal Muscle Loss6 months

loss of skeletal muscle (reported as appendicular lean body mass (LBM) on DXA) as a percent total body mass loss from baseline to 6 months as determined by DXA

Skeletal Muscle Loss12 months

loss of skeletal muscle (reported as appendicular lean body mass (LBM) on DXA) as a percent total body mass loss from baseline to 12 months as determined by DXA

Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire6 months

Median Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire (PAGI-SYM score). Scores are on a 6 point Likert scale 0 (none/absent) to 5 (very severe) symptoms.

Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire12 months

Median Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire (PAGI-SYM score). Scores are on a 6 point Likert scale 0 (none/absent) to 5 (very severe) symptoms.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Vanderbilt University Medical Center🇺🇸 Nashville, Tennessee, United States

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