UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059112 |
|---|---|
| Receipt number | R000067581 |
| Scientific Title | Elucidation of the protective effect of subcutaneous insulin administration against brain amyloid accumulation |
| Date of disclosure of the study information | 2025/09/18 |
| Last modified on | 2025/09/17 15:50:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Elucidation of the protective effect of subcutaneous insulin administration against brain amyloid accumulation
Acronym
Elucidation of the protective effect of subcutaneous insulin administration against brain amyloid accumulation
Scientific Title
Elucidation of the protective effect of subcutaneous insulin administration against brain amyloid accumulation
Scientific Title:Acronym
Elucidation of the protective effect of subcutaneous insulin administration against brain amyloid accumulation
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying the relationship with subcutaneous insulin administration and brain Ab accumulation by quantifying brain Ab accumulation in long-term insulin users and non-users using amyloid PET.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The standardized uptake volume ratio (SUVr) was calculated using the volumes of interest (VOI) of eight domain (frontal lobe, parietal lobe, temporal lobe, occipital lobe, posterior cingulate gyrus, precuneus, basal ganglia, and cerebellum) and Composite (a composite of eight regions) and the mean pixel values of Pons, and the mean cortical SUVr (mcSUVr) was compared between insulin user group and noninsulin user group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Type 2 diabetes treated with subcutaneous insulin injections for more than 10 years
Interventions/Control_2
Patients who have never used subcutaneous insulin injections
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- Patients with type 2 diabetes who was diagnosed for 10 years or more
- Patients aged 65 to 90 years
- MOCA-J score of 18 to 25
- Patients who have been receiving subcutaneous insulin injections for 10 years or more
- Patients who have never received subcutaneous insulin injections
- Patients who have provided written consent to participate in the study
Key exclusion criteria
- Patients who have been previously diagnosed with dementia
- Patients with underlying conditions that cause cognitive impairment
- Heavy alcohol users
- Patients taking medications that affect cognitive function
- Patients for whom PET scans are difficult to perform
- Patients deemed inappropriate by their attending physician
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Fukumi |
| Middle name | |
| Last name | Yoshikawa |
Organization
Toho university school of medicine
Division name
Division of Diabetes, Metabolism, and Endocrinology, Department of internal medicine.
Zip code
143-8541
Address
6-11-1Omori-nishi, Ota-ku
TEL
0337624151
fukumi.yoshikawa@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Fukumi |
| Middle name | |
| Last name | Yoshikawa |
Organization
Toho university school of medicine
Division name
Division of Diabetes, Metabolism, and Endocrinology, Department of internal medicine.
Zip code
108-0014
Address
6-11-1Omori-nishi, Ota-ku, Tokyo
TEL
0337624151
Homepage URL
fukumi.yoshikawa@med.toho-u.ac.jp
Sponsor or person
Institute
Toho university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Toho university school of medicine
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 Toho University Medical Center Omori Hospital
Address
6-11-1 Omori Nishi, Ota-Ku, Tokyo-to 143-8541 Japan
Tel
03-5763-6534
omori.rinri@ext.toho-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
| 2025 | Year | 09 | Month | 18 | 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
| 2025 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 17 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067581
