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

Sponsor
Seoul National University Boramae Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02031913
Collaborator
(none)
500
Enrollment
1
Location
119
Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    acoustic radiation force impulse elastography

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Association Between Insulin Resistance and Hepatic Fibrosis in Combined Chronic Hepatitis B and Non-alcoholic Fatty Liver Disease
    Study Start Date :
    Jan 1, 2013
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    HBV without FL

    Chronic hepatitis B without steatosis
    HBV with FL

    Chronic hepatitis B patients with steatosis

    Outcome Measures

    Primary Outcome Measures

    1. Insulin resistance and fibrosis indices [one year]

      Measurement for insulin resistance and fibrosis index for hepatic fibrosis assessment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul Metropolitan Government Seoul National University Seoul Korea, Republic of 156-707

    Sponsors and Collaborators

    • Seoul National University Boramae Hospital

    Investigators

    • Principal Investigator: Won Kim, Professor, SMG-SNU Boramae Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Won Kim, M.D, PhD, Seoul National University Boramae Hospital
    ClinicalTrials.gov Identifier:
    NCT02031913
    Other Study ID Numbers:
    • HBV_FL
    First Posted:
    Jan 9, 2014
    Last Update Posted:
    May 5, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Won Kim, M.D, PhD, Seoul National University Boramae Hospital
    Chronic hepatitis B
    Hepatic fibrosis
    Steatosis
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis B
    Hepatitis B, Chronic
    Hepatitis
    Hepatitis, Chronic
    Fatty Liver
    Liver Cirrhosis
    Insulin Resistance
    Fibrosis

    Study Results

    No Results Posted as of May 5, 2022