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Metabolic Dysfunction-Associated Steatotic Liver DiseaseK-MASLDNCT06843421

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

An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and Cardiovascular Diseases, run by Korea University at 5 sites in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
How many people
6,000 participants
Where
5 sitesSouth Korea
Study dates
1 Mar 2025to 1 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • An individual who had an abdominal ultrasound performed

Who cannot join

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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Seong Hee Kang, MD., PhD. contact

82-31-412-5114

shkang0114@gmail.com

SungA Bae, MD., PhD. contact

cardiobsa@yuhs.ac

5 sites in 1 country

South Korea5 sites
  • Wonju Severance Christian Hospital

    Gangwon-do, Wonju-si, 26426

  • Chung-Ang University Gwangmyeong Hospital

    Gyeonggi-do, Gwangmyeong-si, 14353

  • Inje Univerisity Sanggye Paik Hospital

    Seoul, Nowon-gu, 1342

  • Ajou University Hospital

    Suwon, Yeongtong-gu, 16502

  • Yonsei University Yongin Severance Hospital

    Yongin, Gyeonggi-do, 16995

Other trials in South Korea

About this study

Official title: Korean Health Screening-Based Metabolic Dysfunction-Associated Steatotic Liver Disease Registry: A Retrospective Multicenter Cross-Sectional Study (K-MASLD Registry)

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:

Read more
  • 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.

Read the detailed description

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is a condition characterized by excessive fat accumulation in the liver, associated with metabolic dysfunction. Unlike traditional concepts of Non-Alcoholic Fatty Liver Disease (NAFLD), MASLD emphasizes the central role of metabolic health in liver disease development. This condition is closely linked with metabolic syndrome components including insulin resistance, hyperglycemia, hypertension, and obesity. Patients with MASLD face increased risks of liver damage and functional decline, potentially progressing to liver fibrosis, cirrhosis, and even liver cancer. Additionally, MASLD shows strong associations with cardiovascular diseases, type 2 diabetes, and rheumatic conditions, making its management crucial for overall health maintenance.

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.

Keywords
Metabolic Dysfunction-Associated Steatotic Liver Disease, Cardiovascular disease
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06843421
Study groupRoleWhat they receive
MASLD (Metabolic dysfunction-associated steatohepatitis) GroupParticipants with fatty liver detected on abdominal ultrasound
Normal GroupParticipants with normal liver findings on abdominal ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence Rate of Major Adverse Cardiovascular Events (MACE)

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

    Measured: within 3 years

Secondary outcomes (1)
  1. Incidence Rate of Cancer

    Cancer was defined as the diagnosis of any malignant neoplasm during the follow-up period.

    Measured: within 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2025
  2. Study start1 Mar 2025 (estimated)
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
6,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06843421
Sponsor's protocol ID
K-MASLD Registry
Acronym
K-MASLD
Status last verified
Feb 2025
First submitted
20 Feb 2025
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29844588
  • 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.

    PubMed 27003601
  • 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.

    PubMed 25935633
  • 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.

    PubMed 24042449
  • 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.

    PubMed 25920090
  • 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.

    PubMed 29967350
  • 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.

    PubMed 21038418
  • 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.

    PubMed 26707365
  • 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.

    PubMed 31287572
  • 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.

    PubMed 32044314
  • Cho HJ, Kang SH, Chon HY, Bae S, Kim E, Na SK, Kim SJ, Kim D, Ahn HR, Kim H, Cheong JY, Baik SK, Jung YK, Kim SS, Yim HJ. Circulating Estradiol as an Independent Risk Factor for Metabolic Dysfunction-Associated Steatotic Liver Disease and Fibrosis Risk in Women: Evidence From a Multicenter Health-Checkup Cohort. J Korean Med Sci. 2026 Nov 2;41(42):e258. doi: 10.3346/jkms.2026.41.e258.

    PubMed 42978133
  • Cho HJ, Kang SH, Chon HY, Bae S, Kim E, Na SK, Kim SJ, Kim D, Ahn HR, Kim H, Kim SS, Cheong JY, Baik SK, Jung YK, Yim HJ. Metabolic Dysfunction-Associated Steatotic Liver Disease and Vascular Complications: Associations with Serum Testosterone Levels in a Korean Multicenter Male Cohort. Gut Liver. 2026 Aug 31. doi: 10.5009/gnl250585. Online ahead of print.

    PubMed 42670694

Questions about this trial

What is this clinical trial studying?

An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and Cardiovascular Diseases, run by Korea University at 5 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seong Hee Kang, MD., PhD. (82-31-412-5114, shkang0114@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Rate of Major Adverse Cardiovascular Events (MACE) (time frame: within 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06843421, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.

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