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])

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]) - 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])

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046016

Enrollment

3150

Registered

2021-11-10

Start date

2021-11-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic steatohepatitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Those who are 20 years old or older at the first visit 2) Those who can provide written informed consent for participation in the study 3) Those who have a mean alcohol intake of 30 g/day or less for men and 20 g/day or less for women in the last 3 months and those who have no history of drinking alcohol 4) Those who meet any of the following conditions: -1.Those with a diagnosis of NASH -2.Those with suspected NAFLD -3.Those with a high possibility of having NAFLD who meet any of the following conditions: - FIB4 index of 1.3 or higher - Age 35 years old or older and BMI of 25 kg/m2 or more and/or triglyceride (TG) level of 150 mg/dL or more

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
(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.	—

Measure

Time frame

(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.

—

Countries

Japan

Contacts

Public ContactHirotaka Nagashima

Medical Corporation Chiseikai Tokyo Center Clinic Clinical Research Group

nagashima_hirotaka@tc-clinic.jp0332766935

Outcome results