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 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
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 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 | |
| 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 Hepadnaviridae Infections DNA Virus Infections Pathologic Processes Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 25, 2017