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:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- histologic steatosis and fibrosis grade
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
Won Kim
M.D, PhD
Seoul National University Boramae Hospital
Study Sites (1)
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