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

NCT ID: NCT07035483

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-18
• Study Completion Date: 2029-12-31

Brief 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

Obesity and Obesity-related Medical Conditions; Sarcopenic Obesity; Adipose Tissue, Abdominal

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

bariatric surgery

This 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shaihong Zhu

OTHER

Sponsor Role: lead

Responsible Party

Shaihong Zhu

Chief of Metabolic and Bariatric Surgery, Xiangya Third Hospital, Central South University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Xiangya Third Hospital, Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

2024552

Identifier Type: -

Identifier Source: org_study_id