Changes in Body Fat and Liver Triglycerides in Adults with Non-Alcoholic Fatty Liver Disease After Bariatric Surgery or Lifestyle Intervention
Led by Chinese University of Hong Kong · Updated on 2025-02-13
80
Participants Needed
1
Research Sites
25 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to understand changes in fat tissues, triglycerides in the liver and pancreas, and cholesterol levels after lifestyle changes or bariatric surgery in people with obesity and Non-Alcoholic Fatty Liver Disease NAFLD. It also tests whether brown fat, a special type of fat that produces heat, can serve as a marker for NAFLD development. The study includes people with mild to morbid obesity, some of whom may have metabolic syndrome or diabetes-related conditions.
Participants are divided into four groups based on obesity severity and treatment choice morbidly obese patients undergoing bariatric surgery, morbidly obese patients choosing lifestyle intervention, mild to moderate obese patients randomized to lifestyle modification, or conventional care. Bariatric surgery involves standard procedures like gastric bypass or sleeve gastrectomy. The lifestyle program includes dietitian-led sessions focusing on diet and exercise over 12 months, with frequent consultations initially and monthly follow-ups thereafter.
Participants undergo detailed assessments including MRI scans of fat tissues and organs at baseline, 4 months, and 12 months, plus blood tests measuring liver function, glucose, insulin resistance, and cholesterol. Physical measurements like weight, height, and waist circumference are recorded along with activity levels. The study measures the response of fat tissues using advanced MRI techniques and blood tests to evaluate treatment effects and the relationship between brown fat and NAFLD over one year.
CONDITIONS
Brief Title
Change of Adipose Tissues and Triglyceride After Bariatric Surgery or Life-style Intervention
Research Team
W
Winnie C Chu, MD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Any condition that prevents safe MRI scanning (MRI contraindications)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants undergo either bariatric surgery or participate in a dietitian-led lifestyle modification program for 12 months. Those in the surgery group receive standard bariatric procedures. Participants in the lifestyle group attend weekly dietary consultation sessions for the first 4 months and monthly sessions for the following 8 months, including exercise consultations. Control group participants receive routine care with general advice on diet and exercise.
Weekly visits for the first 4 months, then monthly visits for the next 8 months for lifestyle group; surgical procedure and follow-up visits for surgery group; routine care visits for control group
Follow-up
Duration - 12 months
Participants attend metabolic assessment visits at 4 months and 12 months post-baseline including blood tests and MRI scans to monitor changes in adipose tissue and liver health.
3 visits (at baseline, 4 months, and 12 months) involving MRI scans and blood tests
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Creating Biological Samples to Develop Preclinical Models for Studying Liver Tumors and Chronic Liver Diseases
AI-Assisted Smart Family Doctor for Managing Hypertension, Diabetes, and Dyslipidemia in Adults After Coronary Artery Bypass Graft or Percutaneous Coronary Intervention
Randomized Phase I Study Comparing Bioavailability and Safety of SHR-3167 Injection in Healthy Adults Aged 18 to 55
Phase 3 Study Testing Safety and Tolerability of Efimosfermin Alfa Injection in Adults With Known or Suspected Moderate to Advanced Metabolic Dysfunction-Associated Steatohepatitis MASH
Study to Map the HLA Genetic Region and Its Possible Links to Diseases in the Greek Population
Study Comparing Muscle and Nerve Function in Adults Aged 60 to 85 Who Are Regular Exercisers or Untrained
Pilot Study of a Fruit and Vegetable Prescription Program to Improve Diabetes Management in Adults with Type 2 Diabetes
Understanding Clinical and Genetic Features of Pyrimidine and Purine Metabolism Disorders Including Family Members and Healthy Volunteers
Evaluating a New Digital Tool to Help Doctors Personalize Exercise Prescriptions for Adults with Cardiovascular Risk Factors
Screening for Pancreatic Cancer in Adults Over 50 with New or Worsening Diabetes Using MRI and Blood Tests
The Relationship Between Brown Adipose Tissue Content in Supraclavicular Fat Depots and Insulin Sensitivity in Patients with Type 2 Diabetes Mellitus and Prediabetes.