Establishment of NAFLD Cohort and Development of Fibrosis Markers (NAFLD)

November 20, 2023 updated by: Won Kim, Seoul National University Boramae Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 156-707
        • Recruiting
        • Seoul Metropolitan Government Seoul National University
        • Contact:
        • Principal Investigator:
          • Won Kim, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Non-alcoholic fatty liver disease

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NAFLD
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.
Procedure: Liver biopsy
Percutaneously liver biopsy will be performed for evaluate steatosis and fibrosis.
Device: ARFI
Acoustic radiation force impulse (ARFI) imaging will be performed for evaluate fibrosis of liver.
Device: SWE
Supersonic shear wave elastography (SWE) will be performed for evaluate fibrosis of liver.
Device: Transient elastography
Transient elastography will be performed for evaluate fibrosis of liver.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,
baseline and every 6 months (up to 1year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Boramae Hospital

Investigators

  • Principal Investigator: Won Kim, Professor, SMG-SNU Boramae Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

July 28, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimated)

August 1, 2014

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAFLD_cohort

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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