UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053682 |
|---|---|
| Receipt number | R000033469 |
| Scientific Title | Cognitive function of elderly type1 diabetes patient, especially in executive function |
| Date of disclosure of the study information | 2024/02/22 |
| Last modified on | 2024/02/22 11:04:29 |
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Basic information
Public title
Cognitive function of elderly type1 diabetes patient, especially in executive function
Acronym
Cognitive function of elderly type1 diabetes
Scientific Title
Cognitive function of elderly type1 diabetes patient, especially in executive function
Scientific Title:Acronym
Cognitive function of elderly type1 diabetes
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the cognitive and executive functions of type 1 diabetes aged 65 years and more, and the differences from those of type2 diabetes by direct comparison with age- and sex-matched subject.
Basic objectives2
Others
Basic objectives -Others
to clarify the relation between cognitive impairment and diabetes-related factors
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MMSE
MocA
TMT-A,B
BADS
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
65 years type1 diabetes and sex and age matched type2 diabetes
Key exclusion criteria
. Exclusion criteria were a neuropsychiatric disorder that could influence cognitive function and a history of
alcohol and substance use. Participants with a history of asymptomatic stroke,
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Yasumichi |
| Middle name | |
| Last name | Mori |
Organization
TORANOMON HOSPITAL
Division name
department of Endocrinology and Metabolism
Zip code
1058470
Address
2-2-2 Toranomon minatoku Tokyo
TEL
0335881111
kaorun318@gmail.com
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Nagasaw |
Organization
TORANOMON HOSPITAL
Division name
department of Endocrinology and Metabolism
Zip code
1058470
Address
2-2-2 Toranomon Minatoku
TEL
0335881111
Homepage URL
kaorun318@gmail.com
Sponsor or person
Institute
Toranonomon Hospital
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
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
Toranomon hospital clinical reserch associates
Address
2-2-2 oranomon minatoku Tokyo
Tel
03-3588-1111
chiken-jim@toranomon.gr.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
| 2024 | Year | 02 | Month | 22 | 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
74
Results
Executive function of psychomotor speed was worse in outpatient older adults without dementia with type 1 than type 2 diabetes mellitus but with no significant differences in
the comprehensive and practical behavioral assessment of dysexecutive syndrome.
Results date posted
| 2024 | Year | 02 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
65　years old and more type1 diabetes and age and sex matched type 2 diabetes without deimentia.
Participant flow
Consent to participate, cognitive function test, blood test
Adverse events
none
Outcome measures
general cognition MMSE, MoCA-J
executive function
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 02 | Month | 22 | Day |
Last modified on
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033469
