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Clinical Trials/NCT02206841
NCT02206841RecruitingNot Applicable

Establishment of Non-alcoholic Fatty Liver Disease Cohort and Development of Markers to Predict Histologic Progression of Liver Fibrosis

Seoul National University Boramae Hospital1 site in 1 country1,000 target enrollmentStarted: January 1, 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
1,000
Locations
1
Primary Endpoint
histologic steatosis and fibrosis grade
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is designed for establishment of non-alcoholic fatty liver disease patients cohort to development of markers to predict histologic progression of liver fibrosis.

Detailed Description

  • Acoustic radiation force impulse elastography and transient elastography
  • Liver tissue (frozen tissue, paraffin block)
  • Whole blood, Serum
  • Fat amount ratio CT (Visceral adipose tissue, Subcutaneous adipose tissue amount)
  • Body composition analyzer (InBody scale):Total fat/muscle mass and appendicular skeletal muscle mass
  • Pulmonary function test with post-bronchodilator response and DLCo
  • EKG, EchoCG, Heart CT (Coronary calcium score), and Pusle wave velocity (AI index, arterial stiffness)
  • Brain MRI or CT
  • Upper esophagogastroscopy and colonoscopy
  • Berlin score questionnaire and Polysomnography

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with histologically confirmed fatty liver disease
  • •Patients with radiologically confirmed fatty liver disease

Exclusion Criteria

  • •History of significant alcohol consumption
  • •Viral hepatitis
  • •Autoimmune hepatitis
  • •Metabolic diseases (e.g. hemochromatosis, M. Wilson, alpha 1-antitrypsin deficiency)
  • •Hepatotoxic medication (e.g. amiodarone)

Outcomes

Primary Outcomes

histologic steatosis and fibrosis grade

Time Frame: baseline

We will evaluate fibrosis using laboratory examination, radiologic evaluation and liver tissue pathology.

Secondary Outcomes

  • Development of markers for hepatic fibrosis progression(baseline and every 6 months (up to 1year))

Investigators

Sponsor
Seoul National University Boramae Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Won Kim

M.D, PhD

Seoul National University Boramae Hospital

Study Sites (1)

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