Establishment of NAFLD Cohort and Development of Fibrosis Markers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liver biopsy, ARFI, SWE, Transient elastography.
- Who it may be relevant to
- Registry conditions: Fibrosis of Liver. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Establishment of Non-alcoholic Fatty Liver Disease Cohort and Development of Markers to Predict Histologic Progression of Liver Fibrosis
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.
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.
Primary outcome measures
- histologic steatosis and fibrosis grade [Time frame: baseline]
Secondary outcome measures (1)
- Development of markers for hepatic fibrosis progression [Time frame: baseline and every 6 months (up to 1year)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Seoul Metropolitan Government Seoul National University — Seoul
Publications
- 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. PMID 29193269
- 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. PMID 28898507
- 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. PMID 28796410
- 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. PMID 28823829
- 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. PMID 28365312
- 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. PMID 27599824
- 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. PMID 29176844
- 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/a PMID 35005800
Identifiers
NCT: NCT02206841 · NAFLD_cohort