Investigation of correlation between the two indexes used to determine the progression of pathological conditions in liver disease (the FIB4 index [an index of progression of liver fibrosis] and the liver fibrosis stage as assessed by FibroScan [a liver fibrosis staging index])
- Conditions
- onalcoholic steatohepatitis
- Registration Number
- JPRN-UMIN000046016
- Lead Sponsor
- Medical Corporation Chiseikai Tokyo Center Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3150
Not provided
1) Those with a history or suspected history of alcoholic liver disease. Significant alcohol intake within 2 years prior to informed consent (mean intake above 210 g/week for men and above 140 g/week for women) for more than 3 consecutive months. 2) Medical history of other chronic liver diseases (viral hepatitis, autoimmune liver disease, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, A1AT deficiency, treatment history of liver transplantation, etc.) 3) Suspected, diagnosed, or history of hepatocellular carcinoma or active, suspected, or history of malignant tumor within 5 years before screening ; however, patients with appropriately treated basal cell carcinoma of the skin or cervical carcinoma in situ do not need to be excluded. 4) Diagnosis of serious or unstable disease of the liver (other than NASH), kidney, digestive organs, respiratory organs, cardiovascular system (including ischemic heart disease) or endocrine, neurological, mental, immune, or blood disorders or other medical conditions that may affect the investigations in this study according to the clinical judgment of the principal investigator. 5) Those who are pregnant or who use a pacemaker.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To understand the correlation between the FIB4 index and liver fibrosis stage as assessed by FibroScan and to examine how many individuals have a high level of fibrosis (F3) among those with an intermediate FIB4 index or higher.
- Secondary Outcome Measures
Name Time Method (1) To examine the sex and age distribution of the FIB4 index levels and clarify how to determine an appropriate cut-off value for the FIB4 index for each age group. (2) To tabulate and examine the FIB4 index as well as the liver fibrosis stage and liver fat levels as assessed by FibroScan, according to the presence or absence of diabetes and dyslipidemia in study participants who have these complications.