Active — Not RecruitingNot Applicable

Changes in Fat and Muscle Tissue Function and Their Impact on Metabolic Health After Bariatric Surgery

China120 participantsStarted 2025-01-18

Plain-language summary

This prospective, single-center observational cohort study aims to explore the relationship between skeletal muscle quality, fat distribution, and metabolic health in Chinese patients with obesity, and to evaluate how bariatric surgery influences these parameters. A total of 120 participants will be enrolled, including 60 patients undergoing bariatric surgery and 60 age- and sex-matched healthy controls. The study involves cross-sectional comparisons of ectopic fat and muscle composition, as well as longitudinal follow-up of surgical patients at multiple time points up to 5 years postoperatively. MRI will be used to quantify regional fat and muscle composition, while metabolic parameters, inflammatory markers, and gut microbiota profiles will also be assessed. Primary outcomes include skeletal muscle mass and fat infiltration, visceral and subcutaneous fat volumes, and changes in insulin resistance. This study seeks to clarify the mechanisms by which bariatric surgery improves metabolic function and to identify early changes in muscle-fat composition that may predict long-term metabolic outcomes.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria (For Surgical Group): * Aged 18 to 65 years (inclusive) * Meets clinical criteria for sleeve gastrectomy or Roux-en-Y gastric bypass surgery * Willing and able to comply with study procedures and follow-up visits Capable of understanding and signing the informed consent form Inclusion Criteria (For Healthy Control Group): * Aged 18 to 65 years (inclusive) * Body mass index (BMI) between 18.0 and 24.0 kg/m² * No history of metabolic disorders (e.g., hypertension, type 2 diabetes, fatty liver disease, or dyslipidemia) * No history of gastrointestinal surgery * Able to undergo MRI and willing to provide baseline clinical data and biological samples * Able to understand and sign informed consent Exclusion Criteria : * Type 1 diabetes mellitus or latent autoimmune diabetes in adults (LADA) * History of pancreatitis, gastrointestinal or pancreatic surgery * Severe complications of type 2 diabetes or major organ dysfunction that may affect surgical safety * Active alcohol or drug dependence, severe psychiatric illness, cognitive impairment, or suicidal ideation * Pregnant or breastfeeding women, or women planning pregnancy during the follow-up period * Contraindications to MRI examination, including: Cardiac pacemaker Artificial heart valves Ferromagnetic vascular clips Metallic foreign bodies in the eye ∙Considered unsuitable for the study by investigators based on risk-benefit assessment

What they're measuring

Change in Skeletal Muscle Fat Infiltration and Quality (measured by MRI)

Timeframe: Baseline, 3 months, 12 months, annually up to 5 years

Change in Visceral and Subcutaneous Fat Volume (measured by MRI)

Timeframe: Baseline, 3 months, 12 months, annually up to 5 years

Trial details

NCT IDNCT07035483

SponsorShaihong Zhu

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31