NCT07035483Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 25 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 8 Jun 2025
- Start date
- 18 Jan 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Shaihong Zhu
- Diseases
- Obesity
- NCT number
- NCT07035483
What you commit to
- Study type: Observational
- Planned participants: 120
- From 18 Jan 2025 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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
Other
- Pregnant or breastfeeding women, or women planning pregnancy during the follow-up period
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xiangya Third Hospital, Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.