Monitoring liver fat changes using a new technology

Monitoring Changes in Hepatic Steatosis During a Lifestyle Intervention Programme in Patients With Non-alcoholic Fatty Liver Disease Using the Novel Continuous Controlled Attenuation Parameter Versus MRI Proton Density Fat Fraction

This study is testing a new way to track changes in liver fat over time for people with non-alcoholic fatty liver disease to see if it works as well as the current method using MRI.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Chinese University of Hong Kong (Academic / other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT06203548 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with intrahepatic triglyceride content of 5% or more and at least one metabolic risk factor.

Not a fit: Patients with other liver diseases or significant alcohol consumption may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more accessible method for monitoring liver fat in patients, potentially leading to better management of fatty liver disease.

How similar studies have performed: While the use of CAP is a newer approach, existing studies have shown promise in using similar technologies for liver fat assessment.

Eligibility criteria

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 this trial is running

Hong Kong

• Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)

Study contacts

• Study coordinator: Vincent Wong, MD

Conditions Fatty Liver