Establishment of NAFLD Cohort and Development of Fibrosis Markers

Recruiting

• Conditions: Fibrosis of Liver

• Registration Number: NCT02206841
• Lead Sponsor: Seoul National University Boramae Hospital

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 Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-08-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2029-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
histologic steatosis and fibrosis grade	baseline	We will evaluate fibrosis using laboratory examination, radiologic evaluation and liver tissue pathology.

Secondary Outcome Measures

Name	Time	Method
Development of markers for hepatic fibrosis progression	baseline and every 6 months (up to 1year)	We will analysis and development fibrosis markers by obtained blood sample and liver tissue,

Trial Locations

Locations (1)

Seoul Metropolitan Government Seoul National University; 🇰🇷 Seoul, Korea, Republic of