Cross-sectional study to estimate the proportion of suspected NASH in obese subjects

Not Applicable

Recruiting

• Conditions: onalcoholic steato-hepatitis

• Registration Number: JPRN-UMIN000051809
• Lead Sponsor: Tokyo Center Clinic. Medical corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-03
• Last Update Posted: 17 October 2023
• Study Completion: 2024-02-29

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

(1)The subjects with a habitual pure ethanol intake of 30g/day or more (male) and 20g/day or more (female). (2)The subjects who has other chronic liver diseases (autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hemochromatosis, alpha1-antitrypsin deficiency, Wilson's disease, drug-induced liver injury (including fatty liver caused by corticosteroids) ), liver cirrhosis). (3) The subjects who have a treatment or a history of malignant tumors of the hepatic/biliary system or pancreas. (4) The subjects who were diagnosed with or treated for malignant tumors within 5 years before consent (excluding cancers that can be cured with topical treatment such as basal cell skin cancer, squamous cell carcinoma, and carcinoma in situ). (5) The subjects who are being treated for or have a medical history of hepatitis B or C. *Regarding medical history, the subjects, who were diagnosed with hepatitis B or C over 2 years ago and confirmed negative for antigen test, can participate in this study. (6) The subjects who have a treatment for or a medical history of portal hypertension or liver failure (ascites, variceal bleeding, idiopathic bacterial peritonitis, hepatic encephalopathy). (7) The subjects who have a history of liver transplantation. (8) The subjects who are judged inappropriate for participation in this study by the principal investigator or co-investigator.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of subjects with suspected NASH based on the cutoff value for liver stiffness of 7.2kPa.

Secondary Outcome Measures

Name	Time	Method
FAST score, FIB-4 Index, NFS, NAFIC , Fibro-Scope, NASH-scope