Establishment of NAFLD Cohort and Development of Fibrosis Markers
NCT ID: NCT02206841
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2014-01-01
2030-12-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Liver biopsy
Percutaneously liver biopsy will be performed for evaluate steatosis and fibrosis.
ARFI
Acoustic radiation force impulse (ARFI) imaging will be performed for evaluate fibrosis of liver.
SWE
Supersonic shear wave elastography (SWE) will be performed for evaluate fibrosis of liver.
Transient elastography
Transient elastography will be performed for evaluate fibrosis of liver.
Interventions
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Liver biopsy
Percutaneously liver biopsy will be performed for evaluate steatosis and fibrosis.
ARFI
Acoustic radiation force impulse (ARFI) imaging will be performed for evaluate fibrosis of liver.
SWE
Supersonic shear wave elastography (SWE) will be performed for evaluate fibrosis of liver.
Transient elastography
Transient elastography will be performed for evaluate fibrosis of liver.
Eligibility Criteria
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Inclusion Criteria
* Patients with radiologically confirmed fatty liver disease
Exclusion Criteria
* Viral hepatitis
* Autoimmune hepatitis
* Metabolic diseases (e.g. hemochromatosis, M. Wilson, alpha 1-antitrypsin deficiency)
* Hepatotoxic medication (e.g. amiodarone)
18 Years
ALL
No
Sponsors
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Seoul National University Boramae Hospital
OTHER
Responsible Party
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Won Kim
M.D, PhD
Principal Investigators
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Won Kim, Professor
Role: PRINCIPAL_INVESTIGATOR
SMG-SNU Boramae Medical Center
Locations
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Seoul Metropolitan Government Seoul National University
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Lee DH, Sung SU, Lee YK, Lim IH, Jang H, Joo SK, Park JH, Chang MS, So YH, Kim W; Innovative Target Exploration of NAFLD (ITEN) Consortium. A sequential approach using the age-adjusted fibrosis-4 index and vibration-controlled transient elastography to detect advanced fibrosis in Korean patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2022 Apr;55(8):994-1007. doi: 10.1111/apt.16766. Epub 2022 Jan 9.
Kim D, Kim W, Joo SK, Han J, Kim JH, Harrison SA, Younossi ZM, Ahmed A. Association between body size-metabolic phenotype and nonalcoholic steatohepatitis and significant fibrosis. J Gastroenterol. 2020 Mar;55(3):330-341. doi: 10.1007/s00535-019-01628-z. Epub 2019 Sep 18.
Kim D, Kim W, Joo SK, Kim JH, Harrison SA, Younossi ZM, Ahmed A. Predictors of nonalcoholic steatohepatitis and significant fibrosis in non-obese nonalcoholic fatty liver disease. Liver Int. 2019 Feb;39(2):332-341. doi: 10.1111/liv.13983. Epub 2018 Oct 27.
Other Identifiers
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NAFLD_cohort
Identifier Type: -
Identifier Source: org_study_id
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