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:

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

History of Changes

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:

Genetics Home Reference related topics: non-alcoholic fatty liver disease

MedlinePlus related topics: Fatty Liver Disease Hepatitis Hepatitis A Hepatitis B

Genetic and Rare Diseases Information Center resources: Visceral Steatosis

U.S. FDA Resources

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

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 September 19, 2017

To Top