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

NCT ID: NCT02031913

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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acoustic radiation force impulse elastography

Conditions

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Chronic Hepatitis B Hepatic Fibrosis Fatty Liver

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HBV without FL

Chronic hepatitis B without steatosis

No interventions assigned to this group

HBV with FL

Chronic hepatitis B patients with steatosis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Boramae Hospital

OTHER

Sponsor Role lead

Responsible Party

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Won Kim

M.D, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Won Kim, Professor

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Locations

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Seoul Metropolitan Government Seoul National University

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HBV_FL

Identifier Type: -

Identifier Source: org_study_id

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