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Obesity and Obesity-related Medical ConditionsNCT07035483

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

An observational study of Obesity and Obesity-related Medical Conditions and Sarcopenic Obesity, run by Shaihong Zhu at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
bariatric surgery
Type of treatment
Surgery or procedure
How many people
120 participants
Where
1 siteChina
Study dates
18 Jan 2025to 31 Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: This study will enroll adult participants aged 18 to 65 years, including two groups: (1) obese patients undergoing bariatric surgery (either sleeve gastrectomy or Roux-en-Y gastric bypass), and (2) healthy individuals with normal BMI (18.0-24.0 kg/m²) and no metabolic comorbidities. The surgical group consists of patients eligible for metabolic surgery based on national clinical guidelines. The healthy control group is matched by age and sex and will undergo only baseline assessments. All participants must be able to provide informed consent and comply with study procedures. The study population is recruited from Xiangya Third Hospital, Central South University.

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xiangya Third Hospital, Central South University

    Changsha, Hunan, 410013

Other trials in China

About this study

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

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.

Read more

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.

Being tested
bariatric surgery
Keywords
Obesity, Ectopic Fat Deposition, Sarcopenic Obesity, Bariatric Surgery, Metabolic Syndrome
Medical subject headings
Obesity, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bariatric surgeryProcedure or 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Quantitative evaluation of intramuscular fat content using MRI-derived proton density fat fraction (PDFF) and muscle attenuation indices in the thigh and paraspinal muscles. Muscle quality will be assessed by MRI signal intensity and texture features to detect early changes in muscle composition post-surgery.

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

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

    MRI-based measurement of visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), liver fat percentage (LFP), and pancreatic fat percentage (PFP) to track region-specific fat redistribution after bariatric surgery.

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

Secondary outcomes (10)

  1. Change in fasting glucose

    Fasting glucose to evaluate metabolic improvement after surgery.

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

  2. Change in HbA1c

    HbA1c to evaluate metabolic improvement after surgery.

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

  3. Change in triglycerides

    Triglycerides to evaluate metabolic improvement after surgery.

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

  4. Change in LDL-C

    LDL-C to evaluate metabolic improvement after surgery.

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

  5. Change in HDL-C

    HDL-C to evaluate metabolic improvement after surgery.

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

  6. Change in total cholesterol

    total cholesterol to evaluate metabolic improvement after surgery.

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

  7. Change in insulin resistance

    HOMA-IR to evaluate metabolic improvement after surgery.

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

  8. Change in body mass index

    Body mass index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²), will be measured at baseline and follow-up visits to assess changes in overall adiposity after bariatric surgery. BMI will be used as a general anthropometric indicator of weight loss efficacy over time.

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

  9. Change in waist circumference

    Waist circumference will be measured in centimeters using a standardized tape measure at the midpoint between the lowest rib and the iliac crest. This anthropometric indicator will be used to evaluate central (abdominal) fat reduction following bariatric surgery. Measurements will be taken at baseline and at follow-up time points to assess longitudinal changes.

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

  10. Change in hip circumference

    Hip circumference will be measured in centimeters at the widest portion of the buttocks using a standardized measuring tape. This anthropometric measure will help assess changes in fat distribution following bariatric surgery. Measurements will be recorded at baseline and follow-up visits to monitor longitudinal changes in body composition.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2025
  2. Study start18 Jan 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07035483
Sponsor's protocol ID
2024552
Status last verified
Jun 2025
First submitted
8 Jun 2025
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) related to primary and secondary outcomes (e.g., MRI measurements, metabolic indicators, and inflammatory markers) may be shared with qualified researchers upon reasonable request. Data will be made available after publication of the main results and approval by the principal investigator.

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Obesity-related Medical Conditions and Sarcopenic Obesity, run by Shaihong Zhu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Skeletal Muscle Fat Infiltration and Quality (measured by MRI) (time frame: Baseline, 3 months, 12 months, annually up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07035483.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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