UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058647 |
|---|---|
| Receipt number | R000067067 |
| Scientific Title | Association between FIB-4 and skeletal muscle mass in Japanese patients with type 2 diabetes |
| Date of disclosure of the study information | 2026/07/30 |
| Last modified on | 2025/07/30 16:29:43 |
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Basic information
Public title
FIB-4 is associated with skeletal muscle mass in Japanese patients with type 2 diabetes
Acronym
Association between FIB-4 and skeletal muscle mass in Japanese patients with type 2 diabetes
Scientific Title
Association between FIB-4 and skeletal muscle mass in Japanese patients with type 2 diabetes
Scientific Title:Acronym
Association between FIB-4 and skeletal muscle mass in Japanese patients with type 2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the relationship between liver fibrosis and muscle mass in patients with type 2 diabetes
Basic objectives2
Others
Basic objectives -Others
Clinical characteristics associated with low SMI
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between FIB-4 and skeletal muscle mass index (SMI)
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
Adult patients with type 2 diabetes and without liver cirrhosis who underwent body composition analysis using bioelectrical impedance analysis
Key exclusion criteria
Steroid users and patients with liver cirrhosis, renal failure, malnutrition, thrombocytopenia, myelodysplasia syndrome, or idiopathic thrombocytopenic purpura
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
1300022
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
TEL
03-3673-1221
ito@edogawa.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
1300022
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
TEL
03-3673-1221
Homepage URL
ito@edogawa.or.jp
Sponsor or person
Institute
Edogawa Hospital
Institute
Department
Personal name
Hiroyuki Ito
Funding Source
Organization
none
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
Ethics Committee of Edogawa Hospital
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
Tel
03-3673-1221
ito@edogawa.or.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 | 07 | Month | 30 | 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
476
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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective cross-sectional study
Management information
Registered date
| 2025 | Year | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067067
