UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060038 |
|---|---|
| Receipt number | R000068621 |
| Scientific Title | Study on the association between metabolic dysfunction-associated steatotic liver disease (MASLD) and serum concentrations of fatty acids |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/12/10 16:08:17 |
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Basic information
Public title
Study on the association between metabolic dysfunction-associated steatotic liver disease (MASLD) and serum concentrations of fatty acids
Acronym
Study on the association between metabolic dysfunction-associated steatotic liver disease (MASLD) and serum concentrations of fatty acids
Scientific Title
Study on the association between metabolic dysfunction-associated steatotic liver disease (MASLD) and serum concentrations of fatty acids
Scientific Title:Acronym
Study on the association between metabolic dysfunction-associated steatotic liver disease (MASLD) and serum concentrations of fatty acids
Region
| Japan |
Condition
Condition
metabolic dysfunction-associated steatotic liver disease (MASLD)
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop indicators which correlate with liver fat accumulation in patients with MASLD, using serum concentrations of fatty acids
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver/spleen (LS) ratio with abdominal plain CT scan and serum concentrations of fatty acids are measured twice at 12 to 18 month intervals. LS ratio reflects fat accumulation in liver. We examine correlations between change of LS ratio and change of fatty acids.
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
Female
Key inclusion criteria
MASLD was diagnosed as patients with hepatic steatosis identified by imaging, and any of 1) to 3)
1) Overweight or Obesity
2) type 2 diabetes
3) at least, two metabolic diseases; hypertention, visceral fat accumulation, glucose intolerance, and dyslipidemia
Key exclusion criteria
while undergoing cancer therapy
CT scan within 1 year
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | SHIGERU |
| Middle name | |
| Last name | YATOH |
Organization
University of Tsukuba
Division name
Toride Community Medical Education Station, University of Tsukuba Hospital
Zip code
302-0032
Address
1926 Nonoi, Toride-shi, Ibaraki, Japan
TEL
0297-78-6111
shigeru.yatoh@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | SHIGERU |
| Middle name | |
| Last name | YATOH |
Organization
Toride-Kitasoma Medical Association Hospital
Division name
Internal Medicine
Zip code
302-0032
Address
1926 Nonoi, Toride-shi, Ibaraki, Japan
TEL
0297-78-6111
Homepage URL
shigeru.yatoh@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
YATOH, SHIGERU
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee, University of Tsukuba, Institute of Medicine
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575
Tel
029-853-3022
sien.ningenss@un.tsukuba.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
| 2026 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 09 | 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
No data
Management information
Registered date
| 2025 | Year | 12 | Month | 10 | Day |
Last modified on
| 2025 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068621
