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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051809

Enrollment

2000

Registered

2023-08-03

Start date

2023-08-07

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 steato-hepatitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Obese subjects(BMI>=25kg/m2) (1) The subjects who were understand the study protocol and written the consent to participate in this study. (2) The subjects who were 18 years old or more at the time of obtain the informed consent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The proportion of subjects with suspected NASH based on the cutoff value for liver stiffness of 7.2kPa.	—

Secondary

Measure	Time frame
FAST score, FIB-4 Index, NFS, NAFIC , Fibro-Scope, NASH-scope	—

Countries

Japan

Contacts

Public ContactMaiko Takahira

CMIC HealthCare Institute Co., Ltd Dx division Med Reach Lab project management group

maiko-takahira@cmicgroup.com03-6779-8163

Outcome results