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NCT Number: NCT02206841

Establishment of NAFLD Cohort and Development of Fibrosis Markers

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.

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Key information

Conditions

Fibrosis of Liver Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul Metropolitan Government Seoul National University

Seoul, 156-707, South Korea

Location status: Recruiting

Location contact

Won Kim, MD, PhD

CONTACT

[email protected]

8228702233

Won Kim, MD,PhD

PRINCIPAL_INVESTIGATOR

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Liver biopsy

Procedure

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

ARFI

Device

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

SWE

Device

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

Transient elastography

Device

Transient elastography will be performed for evaluate fibrosis of liver.

Primary outcomes

  1. histologic steatosis and fibrosis grade

    Time frame: baseline

    We will evaluate fibrosis using laboratory examination, radiologic evaluation and liver tissue pathology.

Secondary outcomes

  1. Development of markers for hepatic fibrosis progression

    Time frame: baseline and every 6 months (up to 1year)

    We will analysis and development fibrosis markers by obtained blood sample and liver tissue,

Study contacts

Contact information is provided by the study sponsor or research team.

Saekyung Joo, MD

CONTACT

[email protected]

821089619285

Won Kim, MD,PhD

CONTACT

[email protected]

8228702233

Sponsors and collaborators

Lead sponsor

Seoul National University Boramae Hospital

Other

Registry information

Official study title

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

Acronym: NAFLD

Important dates

Study start
2014
Primary completion
2029
Study completion
2030
First posted
Aug 1, 2014
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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