Korean Health Screening-Based Metabolic Dysfunction-Associated Steatotic Liver Disease Registry
NCT ID: NCT06843421
Last Updated: 2025-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
6000 participants
OBSERVATIONAL
2025-03-01
2025-12-01
Brief Summary
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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.
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Detailed Description
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The establishment of a multi-center registry for MASLD through Korean health screening data represents a significant advancement in liver disease research. The Korean healthcare system's comprehensive health screening infrastructure provides an exceptional opportunity to study MASLD systematically across multiple centers, as it routinely includes liver ultrasound, metabolic parameter assessments, and cardiovascular evaluations.
This study utilizes data from six major Korean hospitals to establish a detailed registry that will enhance our understanding of MASLD's characteristics and its associations with other health conditions. The liver's role as a central metabolic hub makes it crucial for studying the bidirectional relationship between hepatic function and systemic metabolic disorders. Recent evidence has shown strong connections between fatty liver disease and cardiovascular outcomes, making the inclusion of cardiac CT and carotid ultrasound data particularly valuable. Asian populations, including Koreans, often exhibit distinct patterns of MASLD compared to Western populations, particularly regarding body mass index thresholds and metabolic risk factors.
The registry implements innovative approaches to data collection and analysis by combining multiple data streams from routine health screenings, including advanced imaging techniques, metabolic parameters, inflammatory markers, cardiovascular risk factors, and lifestyle information. To ensure consistency across participating centers, the study employs standardized data collection protocols and unified formatting requirements, with centralized data management at Korea University Ansan Hospital.
The comprehensive approach to studying MASLD through health screening data represents a significant opportunity to advance our understanding of this condition in the Korean population. The findings from this registry will benefit current clinical practice and pave the way for future research and improvements in patient care. As metabolic health continues to be a growing concern globally, this registry's contributions to our understanding of MASLD will have far-reaching implications for public health and clinical practice.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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MASLD (Metabolic dysfunction-associated steatohepatitis) Group
Participants with fatty liver detected on abdominal ultrasound
No interventions assigned to this group
Normal Group
Participants with normal liver findings on abdominal ultrasound
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
19 Years
ALL
No
Sponsors
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Korea University
OTHER
Responsible Party
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Hyung Joon Yim
Professor
Principal Investigators
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Hyung Joon Yim, MD., PhD.
Role: PRINCIPAL_INVESTIGATOR
Korea University Ansan Hospital
Locations
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Chung-Ang University Gwangmyeong Hospital
Gyeonggi-do, Gwangmyeong-si, South Korea
Yonsei University Yongin Severance Hospital
Yongin, Gyeonggi-do, South Korea
Inje Univerisity Sanggye Paik Hospital
Seoul, Nowon-gu, South Korea
Wonju Severance Christian Hospital
Gangwon-do, Wonju-si, South Korea
Ajou University Hospital
Suwon, Yeongtong-gu, South Korea
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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K-MASLD Registry
Identifier Type: -
Identifier Source: org_study_id
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