Actively Recruiting
Monitoring Changes in Hepatic Steatosis Using Continuous Controlled Attenuation Parameter
Led by Chinese University of Hong Kong · Updated on 2024-08-09
150
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Monitoring Changes in Hepatic Steatosis Using Continuous Controlled Attenuation Parameter
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Liver fat content of 5% or more by MRI-PDFF
- At least one metabolic risk factor such as body mass index 63 23 kg/m2, waist circumference 63 90 cm in men or 63 80 cm in women, high fasting glucose, high blood pressure, high triglycerides, or low HDL cholesterol
- Provide informed written consent
You will not qualify if you...
- Positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or other liver diseases
- Alcohol consumption greater than 30 g/day in men or greater than 20 g/day in women
- Signs of liver decompensation such as high bilirubin, low platelet count, prolonged prothrombin time, low albumin, or history of ascites, varices, or encephalopathy
- Contraindications to MRI such as claustrophobia or metallic implants
- History or presence of liver cancer or other malignancies unless in remission for over 5 years
- History of liver transplantation or resection
- Serious other health conditions limiting participation or follow-up attendance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Hong Kong, Hong Kong, 0000
Actively Recruiting
Research Team
V
Vincent Wong, MD
CONTACT
A
Angel Chim, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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