Clinical trial NCT02206841: Establishment of NAFLD Cohort and Development of Fibrosis Markers
Official title: Establishment of Non-alcoholic Fatty Liver Disease Cohort and Development of Markers to Predict Histologic Progression of Liver Fibrosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibrosis of Liver
Keywords: fibrosis
markers
Lead sponsor: Seoul National University Boramae Hospital
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-alcoholic fatty liver disease

Brief summary: 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

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)

Primary outcomes:
measure: histologic steatosis and fibrosis grade
timeFrame: baseline
Secondary outcomes:
measure: Development of markers for hepatic fibrosis progression
timeFrame: baseline and every 6 months (up to 1year)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Won Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.