Korean Health Screening-Based Metabolic Dysfunction-Associated Steatotic Liver Disease Registry

NCT06843421 | Not Yet Recruiting DMC

• 1 other identifier: K-MASLD Registry
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this observational study is to establish a multi-center registry to better understand Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) using health screening data from Korean hospitals. MASLD is a liver condition where excess fat builds up in the liver and is closely linked to metabolic health problems like high blood pressure, diabetes, and obesity. The main questions this study aims to answer are:

• What are the characteristics of people with MASLD?
• How is MASLD related to other health conditions, especially heart and blood vessel diseases?
• What factors might help identify MASLD early? Researchers will compare two groups of people:
• People who have MASLD
• People who don't have MASLD (control group) This study will look at health screening records from 2020 to 2023 from six Korean hospitals. The research team will collect and analyze:
• Basic health information (age, gender, weight, height, waist size)
• Lifestyle habits (drinking, smoking, exercise, eating habits)
• Medical conditions (high blood pressure, diabetes, high cholesterol)
• Results from medical tests including: Liver ultrasound and Fibroscan results Heart CT scans Blood vessel ultrasound Blood test results Other health screening results Participants in this study will not need to do anything new. The researchers will only look at information that was already collected during regular health screenings. All personal information will be protected and kept private. This research could help doctors:
• Better understand who is at risk for MASLD
• Find MASLD earlier
• Develop better ways to prevent and treat MASLD
• Understand how MASLD is connected to other health problems The study will take place over 3 years and includes adults age 19 and older who had health screenings at participating Korean hospitals. People who drink large amounts of alcohol or have other liver diseases will not be included in the study. By learning more about MASLD through this registry study, researchers hope to improve healthcare for people with or at risk for this liver condition.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease; Cardiovascular Diseases

Keywords

Metabolic Dysfunction-Associated Steatotic Liver Disease; Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Incidence Rate of Major Adverse Cardiovascular Events (MACE)

  MACE was defined as the composite endpoint of all-cause death, myocardial infarction, or stroke.

  within 3 years

Secondary Outcomes (1)

• Incidence Rate of Cancer

  within 3 years

Study Arms (2)

MASLD (Metabolic dysfunction-associated steatohepatitis) Group

Participants with fatty liver detected on abdominal ultrasound

Normal Group

Participants with normal liver findings on abdominal ultrasound

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study targets adults aged 19 years and older who underwent health screenings at participating institutions from 2020 to 2023. The study population consists of subjects who had abdominal ultrasonography during their health screening, including those diagnosed with fatty liver (MASLD group, 500 subjects) and those with normal findings on ultrasonography (control group, 500 subjects) from each participating institution. Each of the 6 participating institutions will contribute 1,000 subjects (500 MASLD, 500 controls), for a total study population of 6,000 subjects. Subjects with high alcohol consumption or history of other liver diseases will be excluded from the study. All data will be collected and analyzed retrospectively.

You may qualify if:

• An individual who had an abdominal ultrasound performed

You may not qualify if:

• An individual with high alcohol intake history or other liver disease

Sponsors & Collaborators

• Korea University: lead

Study Sites (5)

Chung-Ang University Gwangmyeong Hospital

Gyeonggi-do, Gwangmyeong-si, 14353, South Korea

Location

Yonsei University Yongin Severance Hospital

Yongin, Gyeonggi-do, 16995, South Korea

Location

Inje Univerisity Sanggye Paik Hospital

Seoul, Nowon-gu, 1342, South Korea

Location

Wonju Severance Christian Hospital

Gangwon-do, Wonju-si, 26426, South Korea

Location

Ajou University Hospital

Suwon, Yeongtong-gu, 16502, South Korea

Location

Related Publications (10)

• Wong VW, Adams LA, de Ledinghen V, Wong GL, Sookoian S. Noninvasive biomarkers in NAFLD and NASH - current progress and future promise. Nat Rev Gastroenterol Hepatol. 2018 Aug;15(8):461-478. doi: 10.1038/s41575-018-0014-9.

  PMID: 29844588 BACKGROUND

• Bedossa P, Patel K. Biopsy and Noninvasive Methods to Assess Progression of Nonalcoholic Fatty Liver Disease. Gastroenterology. 2016 Jun;150(8):1811-1822.e4. doi: 10.1053/j.gastro.2016.03.008. Epub 2016 Mar 19.

  PMID: 27003601 BACKGROUND

• Angulo P, Kleiner DE, Dam-Larsen S, Adams LA, Bjornsson ES, Charatcharoenwitthaya P, Mills PR, Keach JC, Lafferty HD, Stahler A, Haflidadottir S, Bendtsen F. Liver Fibrosis, but No Other Histologic Features, Is Associated With Long-term Outcomes of Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2015 Aug;149(2):389-97.e10. doi: 10.1053/j.gastro.2015.04.043. Epub 2015 Apr 29.

  PMID: 25935633 BACKGROUND

• Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17.

  PMID: 24042449 BACKGROUND

• Byrne CD, Targher G. NAFLD: a multisystem disease. J Hepatol. 2015 Apr;62(1 Suppl):S47-64. doi: 10.1016/j.jhep.2014.12.012.

  PMID: 25920090 BACKGROUND

• Friedman SL, Neuschwander-Tetri BA, Rinella M, Sanyal AJ. Mechanisms of NAFLD development and therapeutic strategies. Nat Med. 2018 Jul;24(7):908-922. doi: 10.1038/s41591-018-0104-9. Epub 2018 Jul 2.

  PMID: 29967350 BACKGROUND

• Tilg H, Moschen AR. Evolution of inflammation in nonalcoholic fatty liver disease: the multiple parallel hits hypothesis. Hepatology. 2010 Nov;52(5):1836-46. doi: 10.1002/hep.24001.

  PMID: 21038418 BACKGROUND

• Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.

  PMID: 26707365 BACKGROUND

• Rinella ME, Tacke F, Sanyal AJ, Anstee QM; participants of the AASLD/EASL Workshop. Report on the AASLD/EASL Joint Workshop on Clinical Trial Endpoints in NAFLD. Hepatology. 2019 Oct;70(4):1424-1436. doi: 10.1002/hep.30782. Epub 2019 Jul 9.

  PMID: 31287572 BACKGROUND

• Eslam M, Sanyal AJ, George J; International Consensus Panel. MAFLD: A Consensus-Driven Proposed Nomenclature for Metabolic Associated Fatty Liver Disease. Gastroenterology. 2020 May;158(7):1999-2014.e1. doi: 10.1053/j.gastro.2019.11.312. Epub 2020 Feb 8.

  PMID: 32044314 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Hyung Joon Yim, MD., PhD.

  Korea University Ansan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seong Hee Kang, MD., PhD.

CONTACT

82-31-412-5114; shkang0114@gmail.com

SungA Bae, MD., PhD.

CONTACT

cardiobsa@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 25, 2025
• Study Start: March 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)