UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059523 |
|---|---|
| Receipt number | R000068087 |
| Scientific Title | A Study on the Current Status of Steatotic Liver Disease in East Asia |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/10/23 20:10:37 |
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Basic information
Public title
A Study on the Current Status of Steatotic Liver Disease in East Asia
Acronym
A Study on the Current Status of Steatotic Liver Disease in East Asia
Scientific Title
A Study on the Current Status of Steatotic Liver Disease in East Asia
Scientific Title:Acronym
A Study on the Current Status of Steatotic Liver Disease in East Asia
Region
| Japan | Asia(except Japan) |
Condition
Condition
Steatotic Liver Disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The global prevalence of fatty liver disease has been increasing with lifestyle changes, and it can progress to cirrhosis or hepatocellular carcinoma if untreated. Recently, new definitions, MASLD, MASH, MetALD, and ALD have been proposed to better reflect the link with metabolic dysfunction. However, their characteristics and clinical relevance in East Asian populations remain unclear.
This study analyzes health check-up data from Japan, Korea, and Taiwan to clarify the prevalence, clinical features, comorbidities, and outcomes of fatty liver disease, aiming to establish region-specific strategies for its early detection and management.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study will investigate the diagnostic accuracy of fatty liver disease, its relationship with metabolic abnormalities, the development of comorbid conditions, disease progression, and clinical outcomes.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants aged over 18 years who underwent health check-ups between April 1, 2013, and March 31, 2029 (planned) at collaborating institutions in Japan (Aichi Health Promotion Foundation, Daido Hospital group, Ogaki Municipal Hospital, Yamashita Hospital, and Toyota Kosei Hospital), Korea (Chung-Ang University Hospital and Korea University College of Medicine Hospital), and Taiwan (National Taiwan University Hospital) are included in this study.
Key exclusion criteria
Individuals for whom the patient or the patient's legal representative does not provide consent for the use of their information in this study will be excluded from participation.
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | Norihiro |
| Middle name | |
| Last name | Imai |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsurumaicho Showa-ku Nagoya-shi
TEL
052-744-2169
norihiro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihiro |
| Middle name | |
| Last name | Imai |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsurumaicho Showa-ku Nagoya-shi
TEL
0527442169
Homepage URL
norihiro@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Norihiro Imai
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku
Tel
0527442169
imai.norihiro.h8@f.mail.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
愛知県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068087
