ClinicalTrials.gg
CompletedNCT02031913Updated Apr 12, 2023

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

An observational study in Chronic Hepatitis B, Hepatic Fibrosis and Fatty Liver, sponsored by Seoul National University Boramae Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-12.

Sponsored by Seoul National University Boramae Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
20 Years to 80 Years
Sex
All
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Study 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.

Read the detailed description

acoustic radiation force impulse elastography

02

Conditions studied

  • Chronic Hepatitis B
  • Hepatic Fibrosis
  • Fatty Liver

Keywords

  • Chronic hepatitis B
  • Hepatic fibrosis
  • Steatosis
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In context

Hepatitis B, Chronic

895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.

This study's enrollment of 500 is above the median of 400 across 206 observational studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

Seoul National University Boramae Hospital is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Chronic hepatitis B patients who showed evidences of hepatic steatosis on ultrasonography

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Chronic patients
  • With evidences of hepatic steatosis on ultrasonography or pathology

Exclusion criteria

Exclusion Criteria:

  • significant alcohol consumption or other known liver diseases
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (actual)
Target follow-up
20 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • HBV without FL

    Chronic hepatitis B without steatosis

  • HBV with FL

    Chronic hepatitis B patients with steatosis

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What researchers measure

Primary outcomes

  1. Insulin resistance and fibrosis indices

    Measurement for insulin resistance and fibrosis index for hepatic fibrosis assessment

    Time frame: one year

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Study locations

1 site
  • Seoul Metropolitan Government Seoul National University
    Seoul, 156-707, Korea, Republic of
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02031913
Lead sponsor
Seoul National University Boramae Hospital
Responsible party
Won Kim (M.D, PhD, Seoul National University Boramae Hospital) — Principal investigator
First posted
Jan 9, 2014
Start date
Jan 2013
Primary completion
Nov 2022
Completion
Dec 2022
Last update
Apr 12, 2023

Study contacts

Won Kim, Professor
principal investigator · SMG-SNU Boramae Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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