Establishment of NAFLD Cohort and Development of Fibrosis Markers

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02206841

Acronym

NAFLD

Enrollment

1000

Registered

2014-08-01

Start date

2014-01-01

Completion date

2030-12-31

Last updated

2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrosis of Liver

Keywords

fibrosis, markers

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

Interventions

PROCEDURELiver biopsy

Percutaneously liver biopsy will be performed for evaluate steatosis and fibrosis.

DEVICEARFI

Acoustic radiation force impulse (ARFI) imaging will be performed for evaluate fibrosis of liver.

DEVICESWE

Supersonic shear wave elastography (SWE) will be performed for evaluate fibrosis of liver.

DEVICETransient elastography

Transient elastography will be performed for evaluate fibrosis of liver.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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,

Countries

South Korea

Contacts

Primary ContactWon Kim, MD,PhD

drwon1@snu.ac.kr8228702233

Backup ContactSaekyung Joo, MD

joo.sammy@gmail.com821089619285

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026