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NCT02031913 Clinical Trial

Prospective Cohort Study of Association of Insulin Resistance/Steatosis With Hepatic Fibrosis in CHB and NAFLD

Chronic Hepatitis B Clinical Trial

Official title:
Association Between Insulin Resistance and Hepatic Fibrosis in Combined Chronic Hepatitis B and Non-alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02031913
Other study ID # HBV_FL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2013
Est. completion date December 2022

Study information
Verified date April 2023
Source Seoul National University Boramae Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Hepatic steatosis and insulin resistance are associated with severity of fibrosis in non-alcoholic fatty liver disease (NAFLD) and chronic hepatitis C. However, clinical significance of steatosis and insulin resistance on fibrosis in chronic hepatitis B (CHB) is not well established. The aim was to investigate the relationship between insulin resistance, hepatic steatosis, and fibrosis in patients with CHB.

Description:

acoustic radiation force impulse elastography

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date December 2022
Est. primary completion date November 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Chronic hepatitis B patients - With evidences of hepatic steatosis on ultrasonography or pathology Exclusion Criteria: - significant alcohol consumption or other known liver diseases

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul Metropolitan Government Seoul National University Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Boramae Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Insulin resistance and fibrosis indices Measurement for insulin resistance and fibrosis index for hepatic fibrosis assessment one year
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