Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID03875625

Change of Adipose Tissues and Triglyceride in Obese Patients With Non-alcoholic Fatty Liver Disease After Bariatric Surgery or Life-style Intervention

Led by Chinese University of Hong Kong · Updated on 2025-02-13

80

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Body mass index (BMI) of 25 to 30 kg/m2
  • BMI of 30 kg/m2 or higher with metabolic syndrome
  • BMI of 35 kg/m2 or higher for morbid obesity
  • Diagnosed with Non-Alcoholic Fatty Liver Disease
  • Age between 18 and 65 years
Not Eligible

You will not qualify if you...

  • Other types of liver diseases
  • Taking medications known to affect liver fat
  • Waist circumference of 150 cm or more
  • Weight of 250 kg or more
  • Any condition that prevents safe MRI scanning (MRI contraindications)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Trial Site Locations

Total: 1 location

1

The Chinese University of Hong Kong, Prince of Wale Hospital

Hong Kong, Shatin, Hong Kong

Actively Recruiting

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Research Team

W

Winnie C Chu, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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