Establishment of NAFLD Cohort and Development of Fibrosis Markers

Overview

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 Title of Study: “Establishment of Non-alcoholic Fatty Liver Disease Cohort and Development of Markers to Predict Histologic Progression of Liver Fibrosis”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2022

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

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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,

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Boramae Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Won Kim, M.D, PhD – Seoul National University Boramae Hospital
  • Overall Official(s)
    • Won Kim, Professor, Principal Investigator, SMG-SNU Boramae Medical Center
  • Overall Contact(s)
    • Won Kim, MD,PhD, 8228702233, drwon1@snu.ac.kr

Citations Reporting on Results

Koo BK, Joo SK, Kim D, Bae JM, Park JH, Kim JH, Kim W. Additive effects of PNPLA3 and TM6SF2 on the histological severity of non-alcoholic fatty liver disease. J Gastroenterol Hepatol. 2018 Jun;33(6):1277-1285. doi: 10.1111/jgh.14056. Epub 2018 Feb 26.

Koo BK, Um SH, Seo DS, Joo SK, Bae JM, Park JH, Chang MS, Kim JH, Lee J, Jeong WI, Kim W. Growth differentiation factor 15 predicts advanced fibrosis in biopsy-proven non-alcoholic fatty liver disease. Liver Int. 2018 Apr;38(4):695-705. doi: 10.1111/liv.13587. Epub 2017 Sep 30.

Joo SK, Kim W, Kim D, Kim JH, Oh S, Lee KL, Chang MS, Jung YJ, So YH, Lee MS, Bae JM, Kim BG. Steatosis severity affects the diagnostic performances of noninvasive fibrosis tests in nonalcoholic fatty liver disease. Liver Int. 2018 Feb;38(2):331-341. doi: 10.1111/liv.13549. Epub 2017 Sep 5.

Kim D, Kim W, Joo SK, Bae JM, Kim JH, Ahmed A. Subclinical Hypothyroidism and Low-Normal Thyroid Function Are Associated With Nonalcoholic Steatohepatitis and Fibrosis. Clin Gastroenterol Hepatol. 2018 Jan;16(1):123-131.e1. doi: 10.1016/j.cgh.2017.08.014. Epub 2017 Aug 18.

Kim JY, Park KJ, Hwang JY, Kim GH, Lee D, Lee YJ, Song EH, Yoo MG, Kim BJ, Suh YH, Roh GS, Gao B, Kim W, Kim WH. Activating transcription factor 3 is a target molecule linking hepatic steatosis to impaired glucose homeostasis. J Hepatol. 2017 Aug;67(2):349-359. doi: 10.1016/j.jhep.2017.03.023. Epub 2017 Mar 30.

Koo BK, Kim D, Joo SK, Kim JH, Chang MS, Kim BG, Lee KL, Kim W. Sarcopenia is an independent risk factor for non-alcoholic steatohepatitis and significant fibrosis. J Hepatol. 2017 Jan;66(1):123-131. doi: 10.1016/j.jhep.2016.08.019. Epub 2016 Sep 4.

Lee MS, Bae JM, Joo SK, Woo H, Lee DH, Jung YJ, Kim BG, Lee KL, Kim W. Prospective comparison among transient elastography, supersonic shear imaging, and ARFI imaging for predicting fibrosis in nonalcoholic fatty liver disease. PLoS One. 2017 Nov 27;12(11):e0188321. doi: 10.1371/journal.pone.0188321. eCollection 2017. Erratum in: PLoS One. 2018 Jun 26;13(6):e0200055.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.