UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042181 |
|---|---|
| Receipt number | R000048150 |
| Scientific Title | Cognitive decline and brain structural alterations caused by metabolic dysfunction in older adults with type 2 diabetes: a prospective observational study. |
| Date of disclosure of the study information | 2020/10/26 |
| Last modified on | 2023/10/24 13:34:24 |
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Basic information
Public title
Cognitive decline and brain structural alterations caused by metabolic dysfunction in older adults with type 2 diabetes: a prospective observational study.
Acronym
Cognitive decline and brain structural alterations caused by metabolic dysfunction in older adults with type 2 diabetes: a prospective observational study.
Scientific Title
Cognitive decline and brain structural alterations caused by metabolic dysfunction in older adults with type 2 diabetes: a prospective observational study.
Scientific Title:Acronym
Cognitive decline and brain structural alterations caused by metabolic dysfunction in older adults with type 2 diabetes: a prospective observational study.
Region
| Japan |
Condition
Condition
Older adults with type 2 diabetes mellitus.
Classification by specialty
| Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to identify the impact of glycemic control determined by using continuous glycemic monitoring (CGM) on cognitive function and brain microstructure among older adults with type 2 diabetes mellitus.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to obtain the clinical data regarding the change in cognitive function and brain microstructure in older adults with type 2 diabetes mellitus.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in a composite score of cognitive function from baseline to a 24-month follow-up.
Key secondary outcomes
1) Changes in brain images assessed using MRI from baseline to a 24-month follow-up.
2) Changes in scores of each cognitive test from baseline to a 24-month follow-up.
3) Changes in ADL scores from baseline to a 24-month follow-up.
4) Changes in the status of frailty from baseline to a 24-month follow-up.
5) Changes in each result of a comprehensive geriatric assessment from baseline to a24-month follow-up.
6) Incident dementia.
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
| 70 | years-old | <= |
Age-upper limit
| 86 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who
1) are diagnosed with type 2 diabetes mellitus.
2) aged 65-85 at the time of enrollment.
3) have no or mild impairment of basic activities of daily living (Barthel Index >= 80).
4) have Japanese version of Montreal Cognitive Assessment [MoCA-J] score of 17-30.
5) have provided a written informed consent on this study and biobank project by subjects.
Key exclusion criteria
Subjects who
1) are diagnosed with type 1 diabetes mellitus.
2) are diagnosed with dementia.
3) are unable to perform cognitive tests.
4) use implanted medical devices, such as pacemakers.
5) decreased cognitive function due to Parkinson's disease, apoplexy, Huntington's disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, aphasia, epilepsy, subdural hematoma, encephalitis/meningitis, multiple sclerosis, or head injury.
6) have any local lesion, such as cerebral infarction(s) detected by CT or MRI before enrollment, that may greatly affect cognitive function.
7) have a history of major depression, bipolar disorder, schizophrenia, or alcohol/drug abuse; have current serious or unstable disease.
8) unsuitable for treatment due to vitamin B1/B12 and/or folate deficiency, or thyroid dysfunction
9) are deemed ineligible for enrollment by the responsible researcher or co-researcher.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Sugimoto |
Organization
National Center for Geriatrics and Gerontology
Division name
Center for Comprehensive Care and Research on Memory Disorders
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
TEL
0562462311
taiki-s@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Sugimoto |
Organization
National Center for Geriatrics and Gerontology
Division name
Center for Comprehensive Care and Research on Memory Disorders
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
TEL
0562462311
Homepage URL
taiki-s@ncgg.go.jp
Sponsor or person
Institute
Center for Comprehensive Care and Research on Memory Disorders, National Center for Geriatrics and Gerontology.
Institute
Department
Personal name
Funding Source
Organization
Research Funding of Longevity Sciences from the National Center for Geriatrics and Gerontology (20-22)
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
Research and Medical Division, National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
Tel
0562462311
yaday@ncgg.go.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
| 2020 | Year | 10 | Month | 26 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Open public recruiting
Management information
Registered date
| 2020 | Year | 10 | Month | 21 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048150
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