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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02031913
Recruitment Status : Recruiting
First Posted : January 9, 2014
Last Update Posted : April 24, 2018
Information provided by (Responsible Party):
Won Kim, Seoul National University Boramae Hospital

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
Chronic Hepatitis B Hepatic Fibrosis Fatty Liver

Detailed Description:
acoustic radiation force impulse elastography

Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: Association Between Insulin Resistance and Hepatic Fibrosis in Combined Chronic Hepatitis B and Non-alcoholic Fatty Liver Disease
Study Start Date : January 2013
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

HBV without FL
Chronic hepatitis B without steatosis
HBV with FL
Chronic hepatitis B patients with steatosis

Primary Outcome Measures :
  1. Insulin resistance and fibrosis indices [ Time Frame: one year ]
    Measurement for insulin resistance and fibrosis index for hepatic fibrosis assessment

Biospecimen Retention:   Samples Without DNA
We intended to collect sera from registered subjects, but no biospecimens are to be retained yet.

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic hepatitis B patients who showed evidences of hepatic steatosis on ultrasonography

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02031913

Korea, Republic of
Seoul Metropolitan Government Seoul National University Recruiting
Seoul, Korea, Republic of, 156-707
Contact: Won Kim, M.D, PhD    8228702233   
Contact: Saekyung Joo, M.D    821089619285   
Principal Investigator: Won Kim, M.D, PhD         
Sponsors and Collaborators
Seoul National University Boramae Hospital
Principal Investigator: Won Kim, Professor Seoul Metropolitan Government Seoul National University Boramae Medical Center

Responsible Party: Won Kim, M.D, PhD, Seoul National University Boramae Hospital Identifier: NCT02031913     History of Changes
Other Study ID Numbers: HBV_FL
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Won Kim, Seoul National University Boramae Hospital:
Chronic hepatitis B
Hepatic fibrosis

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Insulin Resistance
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes
Hepadnaviridae Infections
DNA Virus Infections
Glucose Metabolism Disorders
Metabolic Diseases