Status:
RECRUITING
Monitoring Changes in Hepatic Steatosis Using Continuous Controlled Attenuation Parameter
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Fatty Liver
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Background: Non-alcoholic fatty liver disease (NAFLD) affects 30% of the Asian adult population and is emerging as one of the important leading causes of liver cancer and cirrhosis. Although a number ...
Detailed Description
STUDY DESIGN OVERVIEW In order to evaluate the use of continuous CAP to monitor changes in liver fat over time, we need a cohort of patients with varying degree of liver fat reduction. Therefore, we w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06203548
Start Date
February 1 2024
End Date
April 30 2027
Last Update
August 9 2024
Active Locations (1)
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1
Prince of Wales Hospital
Hong Kong, Hong Kong, 0000