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

NCT02031913 | Completed

• 1 other identifier: HBV_FL
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B; Hepatic Fibrosis; Fatty Liver

Keywords

Chronic hepatitis B; Hepatic fibrosis; Steatosis

Outcome Measures

Primary Outcomes (1)

• Insulin resistance and fibrosis indices

  Measurement for insulin resistance and fibrosis index for hepatic fibrosis assessment

  one year

Study Arms (2)

HBV without FL

Chronic hepatitis B without steatosis

HBV with FL

Chronic hepatitis B patients with steatosis

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic hepatitis B patients who showed evidences of hepatic steatosis on ultrasonography

You may qualify if:

• Chronic hepatitis B patients
• With evidences of hepatic steatosis on ultrasonography or pathology

You may not qualify if:

• significant alcohol consumption or other known liver diseases

Sponsors & Collaborators

• Seoul National University Boramae Hospital: lead

Study Sites (1)

Seoul Metropolitan Government Seoul National University

Seoul, 156-707, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

We intended to collect sera from registered subjects, but no biospecimens are to be retained yet.

MeSH Terms

Conditions

Hepatitis B, Chronic; Liver Cirrhosis; Fatty Liver

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Study Officials

• Won Kim, Professor

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, PhD

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 9, 2014
• Study Start: January 1, 2013
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)