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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Seoul National University Boramae Hospital
Information provided by (Responsible Party):
Won Kim, Seoul National University Boramae Hospital Identifier:
First received: January 8, 2014
Last updated: December 1, 2015
Last verified: December 2015
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.

Chronic Hepatitis B
Hepatic Fibrosis
Fatty Liver

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Seoul National University Boramae Hospital:

Primary Outcome Measures:
  • Insulin resistance and fibrosis indices [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 500
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
HBV without FL
Chronic hepatitis B without steatosis
HBV with FL
Chronic hepatitis B patients with steatosis

Detailed Description:
acoustic radiation force impulse elastography

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Won Kim, M.D, PhD, Seoul National University Boramae Hospital Identifier: NCT02031913     History of Changes
Other Study ID Numbers: HBV_FL 
Study First Received: January 8, 2014
Last Updated: December 1, 2015
Health Authority: Korea: Ministry for Health and Welfare

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

Additional relevant MeSH terms:
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Hepatitis, Viral, Human
Fatty Liver
Insulin Resistance
Liver Cirrhosis
Non-alcoholic Fatty Liver Disease
DNA Virus Infections
Digestive System Diseases
Glucose Metabolism Disorders
Hepadnaviridae Infections
Liver Diseases
Metabolic Diseases
Pathologic Processes
Virus Diseases processed this record on May 23, 2016