Establishment of NAFLD Cohort and Development of Fibrosis Markers

Fibrosis of Liver Clinical Trial

— NAFLD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02206841
• Other study ID #: NAFLD_cohort
• Status: Recruiting
• Start date: January 1, 2014
• Est. completion date: December 31, 2030

Study information

• Verified date: November 2023
• Source: Seoul National University Boramae Hospital
• Contact: Won Kim, MD,PhD
• Phone: 8228702233
• Email: drwon1[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fibrosis
• Fibrosis of Liver

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul Metropolitan Government Seoul National University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Boramae Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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: — View 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. — View 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):34 — View 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. — View 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. — View 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.1 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	histologic steatosis and fibrosis grade	We will evaluate fibrosis using laboratory examination, radiologic evaluation and liver tissue pathology.	baseline
Secondary	Development of markers for hepatic fibrosis progression	We will analysis and development fibrosis markers by obtained blood sample and liver tissue,	baseline and every 6 months (up to 1year)