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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorKorea University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

An individual who had an abdominal ultrasound performed

Disqualifiers

An individual with high alcohol intake history or other liver disease

Trial 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.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

6,000 Participants
are grouped into 2 trial groups
Group A: MASLD (Metabolic dysfunction-associated steatohepatitis) Group
Group B: Normal Group

Trial outcomes

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.

Time frame
within 3 years

Secondary outcomes

1

Incidence Rate of Cancer

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

Time frame
within 3 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: