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

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ClinicalTrials.gov Identifier: NCT02031913
Recruitment Status : Recruiting
First Posted : January 9, 2014
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Won Kim, Seoul National University Boramae Hospital

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
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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 : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
HBV without FL
Chronic hepatitis B without steatosis
HBV with FL
Chronic hepatitis B patients with steatosis


Outcome Measures
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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.

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
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
Criteria

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT02031913


Locations
Korea, Republic of
Seoul Metropolitan Government Seoul National University Recruiting
Seoul, Korea, Republic of, 156-707
Contact: Won Kim, M.D, PhD    8228702233    drwon1@snu.ac.kr   
Contact: Saekyung Joo, M.D    821089619285    joo.sammy@gmail.com   
Principal Investigator: Won Kim, M.D, PhD         
Sponsors and Collaborators
Seoul National University Boramae Hospital
Investigators
Principal Investigator: Won Kim, Professor Seoul Metropolitan Government Seoul National University Boramae Medical Center
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Won Kim, M.D, PhD, Seoul National University Boramae Hospital
ClinicalTrials.gov Identifier: NCT02031913     History of Changes
Other Study ID Numbers: HBV_FL
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
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
Steatosis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Fibrosis
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
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases