Establishment of Non-alcoholic Fatty Liver Disease Cohort and Development of Markers to Predict Histologic Progression of Liver Fibrosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibrosis of Liver
- Sponsor
- Seoul National University Boramae Hospital
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- histologic steatosis and fibrosis grade
- Status
- Recruiting
- Last Updated
- 11 months ago
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
Investigators
Won Kim
M.D, PhD
Seoul National University Boramae Hospital
Eligibility Criteria
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))