UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060958 |
|---|---|
| Receipt number | R000069755 |
| Scientific Title | Role of dysregulated cholesterol metabolism in the pathogenesis of metabolic dysfunction-associated fatty liver disease |
| Date of disclosure of the study information | 2026/03/17 |
| Last modified on | 2026/03/17 11:07:24 |
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Basic information
Public title
Role of dysregulated cholesterol metabolism in the pathogenesis of metabolic dysfunction-associated fatty liver disease
Acronym
Association between metabolic dysfunction-associated fatty liver disease and dysregulated cholesterol metabolism
Scientific Title
Role of dysregulated cholesterol metabolism in the pathogenesis of metabolic dysfunction-associated fatty liver disease
Scientific Title:Acronym
Association between metabolic dysfunction-associated fatty liver disease and dysregulated cholesterol metabolism
Region
| Japan |
Condition
Condition
Metabolic dysfunction-associated steatotic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the significance of impaired cholesterol metabolism in the pathogenesis of MASLD by comparing the frequency of cholesterol crystallization in the liver with pathological findings related to fibrosis, inflammation, and steatosis. It also aims to identify circulating biomarkers that reflect cholesterol crystallization and to develop a diagnostic method for metabolic dysfunction-associated steatohepatitis (MASH) based on disordered cholesterol metabolism.
Basic objectives2
Others
Basic objectives -Others
Clarifying the role of dysregulated cholesterol metabolism in the onset and progression of MASH
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of pathological findings in MASLD (MASLD activity score and fibrosis stage) with cholesterol crystallization and the distribution and phenotype of macrophages
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with suspected MASLD who are scheduled for liver biopsy
Key exclusion criteria
Presence of other liver diseases, including alcohol-related liver disease, drug-induced liver injury, viral hepatitis, autoimmune liver disease, and metabolic liver diseases
Patients considered unsuitable for this study by the principal investigator or sub-investigator
Patients who do not provide consent to participate in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Itoh |
Organization
Tokyo Medical University
Division name
Department of Biochemistry
Zip code
160-8402
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3351-6141
ito.michiko.3r@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Katsutoshi |
| Middle name | |
| Last name | Sugimoto |
Organization
Tokyo Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
160-0023
Address
6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
sugimoto@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Institutional Review Board
Address
6-7-1, Nishi-shinjuku, Shinjuku-ku, Tokyo
Tel
03-3342-6111
adm_irb@tokyo-med.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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 17 | 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
| 2025 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Samples will be collected in the Department of Gastroenterology, and tissue and blood analyses will be performed in the Division of Biochemistry.
Management information
Registered date
| 2026 | Year | 03 | Month | 17 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069755
