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Prospective Cohort Study of Association of Insulin Resistance/Steatosis With Hepatic Fibrosis in CHB and NAFLD
This study is currently recruiting participants.
Verified October 2016 by Won Kim, Seoul National University Boramae Hospital
Sponsor:
Seoul National University Boramae Hospital
Information provided by (Responsible Party):
Won Kim, Seoul National University Boramae Hospital
ClinicalTrials.gov Identifier:
NCT02031913
First received: January 8, 2014
Last updated: October 13, 2016
Last verified: October 2016
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Purpose
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 |
|---|
| 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 Won Kim, Seoul National University Boramae Hospital:
Primary Outcome Measures:
- 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.
| 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) |
| Groups/Cohorts |
|---|
|
HBV without FL
Chronic hepatitis B without steatosis
|
|
HBV with FL
Chronic hepatitis B patients with steatosis
|
Detailed Description:
acoustic radiation force impulse elastography
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT02031913
Please refer to this study by its ClinicalTrials.gov identifier: 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
| 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 |
| Study First Received: | January 8, 2014 |
| Last Updated: | October 13, 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 |
ClinicalTrials.gov processed this record on July 21, 2017