Monitoring liver fat changes using a new technology

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of continuous controlled attenuation parameter (CAP) measurements in monitoring liver fat changes over time in patients with non-alcoholic fatty liver disease (NAFLD). Participants will undergo a lifestyle intervention program, with assessments of liver fat using CAP and MRI-PDFF at baseline and after six months. The study will involve multiple clinic visits for medical history, physical examinations, blood tests, and imaging procedures to ensure comprehensive monitoring of liver health. The goal is to determine if CAP can serve as a reliable, cost-effective alternative to MRI for tracking liver fat reduction.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Intrahepatic triglyceride content by MRI-PDFF ≥5%
* At least one metabolic risk factor out of (1) body-mass index ≥23 kg/m2, (2) waist circumference ≥90 cm in men and ≥80 cm in women, (3) fasting plasma glucose ≥5.6 mmol/L, 2-hour post-load glucose ≥7.8 mmol/L, haemoglobin A1c (HbA1c) ≥5.7%, known diabetes or on treatment for type 2 diabetes, (4) blood pressure ≥130/85 mmHg or on treatment for hypertension, (5) plasma triglycerides ≥1.7 mmol/L or on treatment for dyslipidaemia, and (6) plasma high-density lipoprotein-cholesterol ≤1.0 mmol/L in men and ≤1.3 mmol/L in women or on treatment for dyslipidaemia
* Provide informed written consent

Exclusion Criteria:

* Positive hepatitis B surface antigen or anti-hepatitis C virus antibody, or history or evidence of other liver diseases
* Alcohol consumption \>30 g per day in men or \>20 g per day in women
* Liver decompensation, as evidenced by total bilirubin \>50 µmol/L (except in patients with documented Gilbert's syndrome), platelet count \<100 x 109/L, prothrombin time \>1.3 times the upper limit of normal, albumin \<35 g/L, or history or presence of ascites, varices or hepatic encephalopathy
* Contraindications to MRI examination such as claustrophobia or the presence of metallic implants
* History or presence of hepatocellular carcinoma
* History of other malignancies, unless in complete remission for more than 5 years
* History of liver transplantation or liver resection
* Significant co-morbidities that will likely limit a patient's participation in lifestyle intervention or attendance of study follow-ups

Where it's running

• Prince of Wales Hospital
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Vincent Wong, MD
• Email: wongv@cuhk.edu.hk
• Phone: +85235054205

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.