Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT07035483

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

Changes in Adipose and Muscle Tissue Function and Their Impact on Metabolic Health Following Bariatric Surgery

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
120 (estimated)
Sponsor
Shaihong Zhu · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREbariatric surgeryThis is a prospective observational study evaluating the metabolic and tissue-level effects of bariatric surgery in obese individuals. The intervention includes either laparoscopic sleeve gastrectomy (LSG) or Roux-en-Y gastric bypass (RYGB), performed according to standard clinical guidelines. No experimental procedures are added beyond routine care. Skeletal muscle quality and visceral fat distribution are assessed using MRI and clinical biomarkers at multiple postoperative time points (baseline, 3 months, 12 months, and annually up to 5 years). A healthy control group undergoes baseline evaluation only, without surgical intervention.

Timeline

Start date
2025-01-18
Primary completion
2025-12-31
Completion
2029-12-31
First posted
2025-06-25
Last updated
2025-06-25

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07035483. Inclusion in this directory is not an endorsement.