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
|
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Condition or disease |
---|
Chronic Hepatitis B Hepatic Fibrosis Fatty Liver |
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 |

Group/Cohort |
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HBV without FL
Chronic hepatitis B without steatosis
|
HBV with FL
Chronic hepatitis B patients with steatosis
|
- 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

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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 |
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

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
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 |
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 |
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 |