Monitoring Changes in Hepatic Steatosis Using Continuous Controlled Attenuation Parameter
Recruiting · NCT06203548 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 of biomarkersmany have been developed for the assessment of liver fat and fibrosis, most existing studies were cross-sectional in nature. The role of these biomarkers for monitoring and response assessment remains elusive. At present, magnetic resonance imaging proton density fat fraction (MRI-PDFF) is considered the gold standard to in quantifying liver fat. The MRI-PDFF response, defined as a ≥30% relative reduction in liver fat fraction, has been shown to correlate with improved hepatic inflammation and fibrosis. However, MRI is limited by cost and availability. The cContinuous controlled attenuation parameter (CAPc) measurement by vibration controlled transient elastography is a new technology to quantify liver fat. It is a point-of-care test and has the potential to replace the MRI-PDFF as a monitoring and response biomarker in routine practice. Study plan: This prospective cohort study will include 150 patients with NAFLD who will join a 6-month lifestyle modification programme involving dietary intervention and physical training. This will create a cohort of varying degrees of liver fat reduction. Using MRI-PDFF as the reference standard, we will evaluate the accuracy of a changes in CAPc in reflecting the MRI-PDFF response and remission of NAFLD, with all non-invasive tests performed at screening and Month 6. In addition, we will test the hypothesis that the the change in CAPc is superior to the change of in other steatosis tests results (including the original CAP, abdominal ultrasonography and steatosis scores of fatty liver index, hepatic steatosis index, NAFLD liver fat score and NAFLD ridge score) in predicting the MRI-PDFF response. The area under the receiver-operating characteristics curve of the CAPc response in predicting the MRI-PDFF response will be compared with that of the other steatosis tests using the DeLong test.
Who can take part
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 is running
1 location listed.
- Prince of Wales Hospital - Hong Kong, Hong Kong