Changes in Fat and Muscle Tissue Function and Their Impact on Metabolic Health After Bariatric Su… (NCT07035483) | Clinical Trial Compass
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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Skeletal Muscle Fat Infiltration and Quality (measured by MRI)
Timeframe: Baseline, 3 months, 12 months, annually up to 5 years
2
Change in Visceral and Subcutaneous Fat Volume (measured by MRI)
Timeframe: Baseline, 3 months, 12 months, annually up to 5 years