UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011953 |
|---|---|
| Receipt number | R000013957 |
| Scientific Title | Predictive Factors for Metabolic Dysfunction-Associated Steatotic Liver Disease in Individuals Undergoing Health Checkups |
| Date of disclosure of the study information | 2013/10/03 |
| Last modified on | 2025/04/25 23:40:37 |
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Basic information
Public title
Predictive Factors for Metabolic Dysfunction-Associated Steatotic Liver Disease in Individuals Undergoing Health Checkups
Acronym
Predictive factor for MASLD
Scientific Title
Predictive Factors for Metabolic Dysfunction-Associated Steatotic Liver Disease in Individuals Undergoing Health Checkups
Scientific Title:Acronym
Predictive factor for MASLD
Region
| Japan |
Condition
Condition
Metabolic Dysfunction Associated Steatotic Liver Disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to identify MASLD by determining an appropriate cutoff value for alanine aminotransferase (ALT) and to explore predictive factors for its presence. In addition, using anonymized data from individuals who have undergone health checkups at least twice, we will analyze risk factors associated with the development of MASLD and other metabolic diseases.
Basic objectives2
Others
Basic objectives -Others
usefulness
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Determine the optimal cutoff value of alanine aminotransferase (ALT) for screening MASLD.
2. Identify predictive factors for the presence of MASLD.
3. Identify predictive factors for the onset and progression of MASLD.
4. Identify predictive factors for the development and progression of metabolic diseases.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Male and female participants aged 18 years or older.
Key exclusion criteria
Exclusion criteria may be adjusted based on the variables included in each analysis.
Target sample size
40000
Research contact person
Name of lead principal investigator
| 1st name | Teruki |
| Middle name | |
| Last name | Miyake |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
7910295
Address
Toon City, Ehime, Japan
TEL
0899605308
teruki-ygc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Teruki |
| Middle name | |
| Last name | Miyake |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
7910295
Address
Toon City, Ehime, Japan
TEL
0899605308
Homepage URL
teruki-ygc@umin.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Ehime University Hospital
Address
Shitsukawa, Toon City, Ehime, Japan
Tel
0899605914
cttc@m.ehime-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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2040 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this community-based study, we review the medical records of Japanese subjects (age range, 18-90 years), who had undergone annual health checkup between April 2003 and March 2025. The annual health checkup includes recording the subject's lifestyle habits, medical history, and history of prescribed medication; conducting a physical examination; and measuring anthropometric and routine biochemical variables. We explore predictive factors for MASLD and metabolic disease.
Management information
Registered date
| 2013 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013957
