NCT02206841: NAFLD

Establishment of NAFLD Cohort and Development of Fibrosis Markers

Recruiting now Last updated 15 May 2025

What this trial tests

trial testing Liver biopsy in Fibrosis of Liver in 1,000 participants. Currently enrolling.

Timeline

1 January 2014

Primary endpoint
31 December 2029

31 December 2030

Quick facts

Lead sponsor	Seoul National University Boramae Hospital
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	1 January 2014
Primary completion	31 December 2029
Estimated completion	31 December 2030
Sites	1 location across South Korea

Drugs / interventions tested

• Liver biopsy — full drug profile →
• ARFI
• SWE
• Transient elastography

Conditions studied

• Fibrosis of Liver — all drugs for Fibrosis of Liver →

Sponsor

Seoul National University Boramae Hospital

Who can join

18 and older, any sex, with Fibrosis of Liver. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Subclinical Hypothyroidism and Low-Normal Thyroid Function Are Associated With Nonalcoholic Steatohepatitis and Fibrosis.
   Kim D, Kim W, Joo SK, Bae JM, et al · · 2018 · cited 141× · PMID 28823829 · DOI 10.1016/j.cgh.2017.08.014
2. Interaction effect between NAFLD severity and high carbohydrate diet on gut microbiome alteration and hepatic <i>de novo</i> lipogenesis.
   Kang H, You HJ, Lee G, Lee SH, et al · · 2022 · cited 33× · PMID 35634707 · DOI 10.1080/19490976.2022.2078612
3. Gut microbiome signatures distinguish type 2 diabetes mellitus from non-alcoholic fatty liver disease.
   Si J, Lee G, You HJ, Joo SK, et al · · 2021 · cited 27× · PMID 34849196 · DOI 10.1016/j.csbj.2021.10.032
4. Association between telomere length and hepatic fibrosis in non-alcoholic fatty liver disease.
   Shin HK, Park JH, Yu JH, Jin YJ, et al · · 2021 · cited 22× · PMID 34504179 · DOI 10.1038/s41598-021-97385-2
5. Current Therapeutical Approaches Targeting Lipid Metabolism in NAFLD.
   Vitulo M, Gnodi E, Rosini G, Meneveri R, et al · · 2023 · cited 21× · PMID 37628929 · DOI 10.3390/ijms241612748
6. Association between body size-metabolic phenotype and nonalcoholic steatohepatitis and significant fibrosis.
   Kim D, Kim W, Joo SK, Han J, et al · · 2020 · cited 20× · PMID 31535207 · DOI 10.1007/s00535-019-01628-z
7. 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.
   Lee DH, Sung SU, Lee YK, Lim IH, et al · · 2022 · cited 10× · PMID 35005800 · DOI 10.1111/apt.16766
8. Liver Stiffness Directs Intrahepatic Cholesterol Accumulation Through YAP/TAZ in Metabolic Dysfunction-Associated Steatotic Liver Disease.
   Lee NY, Choi MG, Ryu HJ, Min YJ, et al · · 2026 · PMID 41747066 · DOI 10.1002/advs.202500379