Establishment of NAFLD Cohort and Development of Fibrosis Markers

Seoul National University Boramae Hospital

Status: Enrolling

Conditions: Fibrosis of Liver

Treatments: Procedure: Liver biopsy; Device: ARFI; Device: SWE; Device: Transient elastography

Study type: Observational

Funder types: Other

Identifiers

NCT02206841

NAFLD_cohort

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,000 participants in 1 patient group

NAFLD

Description:

Patients with suspected nonalcoholic fatty liver disease will be screened. Of all patients fulfilling inclusion criteria, baseline characteristics will be obtained. In addition, laboratory, radiologic evaluations such as ARFI, SWE, and transient elastography will be performed. A diagnostic liver biopsy will be performed for analysis of steatosis and fibrosis. Parts of the remaining liver tissue will be stored by frozen tissue and paraffin block for future study. Several serum and plasma samples are collected of patients and stored for future analysis such as targeted SNP arrays, super-enhancer RNA (eRNA) expression, whole exome sequencing, RNA chip sequencing, RNA microarray, genomic DNA, metabolomics, fecal microbiome, metabolite, metagenome/metatranscriptome analyses.

Treatment:

Device: Transient elastography

Device: SWE

Device: ARFI

Procedure: Liver biopsy