Monitoring Changes in Hepatic Steatosis Using Continuous Controlled Attenuation Parameter

Launched by CHINESE UNIVERSITY OF HONG KONG · Jan 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new method to monitor and measure liver fat in patients with non-alcoholic fatty liver disease (NAFLD), which is a condition that affects many people and can lead to serious liver problems. Researchers want to see if a new test called the Continuous Controlled Attenuation Parameter (CAPc) can accurately reflect changes in liver fat after patients participate in a 6-month lifestyle program that includes diet changes and exercise. The trial will involve 150 participants, and they will undergo MRI scans to serve as a reference for comparing the new CAPc test.

To be eligible for this trial, participants need to have a certain level of fat in their liver and at least one risk factor, such as being overweight or having high blood sugar. They must also be willing to provide written consent to join the study. Throughout the trial, participants can expect regular health assessments to track their progress and how well the CAPc test works. It's important to note that individuals with certain liver conditions, significant alcohol use, or specific health issues may not qualify for the study.

Gender

ALL

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