UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042499 |
|---|---|
| Receipt number | R000048512 |
| Scientific Title | The Study to Develop the Guiding Principle of Diabetes Management Aiming to Prevent the Progression of Dementia: A Proposal on the Basis of the Systematic Review |
| Date of disclosure of the study information | 2020/11/30 |
| Last modified on | 2020/11/19 14:25:55 |
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Basic information
Public title
The Study to Develop the Guiding Principle of Diabetes Management Aiming to Prevent the Progression of Dementia: A Proposal on the Basis of the Systematic Review
Acronym
The Study to Develop the Guiding Principle of Diabetes Management Aiming to Prevent the Progression of Dementia: A Proposal on the Basis of the Systematic Review
Scientific Title
The Study to Develop the Guiding Principle of Diabetes Management Aiming to Prevent the Progression of Dementia: A Proposal on the Basis of the Systematic Review
Scientific Title:Acronym
The Study to Develop the Guiding Principle of Diabetes Management Aiming to Prevent the Progression of Dementia: A Proposal on the Basis of the Systematic Review
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the Asian region, particularly in Japanese population, there has been little evidence regarding the potential effects of the diabetes control on suppressing the progression of dementia. In the present study, we performed a SR in which the review questions were: 1) "does the intervention for the treatment of diabetes (medication, exercise therapy, leisure activity, and diet therapy) suppress the cognitive impairment?" and 2)"is there any potential predictive marker for cognitive impairment?"
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Cognitive decline
2) Onset of dementia
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
I. Intervention study (Review questions 1)
a) PICOS:
Patient: Type 2 diabetes
Intervention:
i) Drugs (hyperglycemic drugs, antihypertensive drugs, dyslipidemia drugs, antiplatelet drugs)
ii) Exercise, leisure, depression
iii) Diet (dietary nutrients, vitamins, supplements, drinking)
Comparison: Normal medical care group
Outcome: i) Cognitive decline, ii) Onset of dementia
b) Intervention / follow-up period: intervention period of 3 months or more, follow-up period of 3 months or more
c) Presentation language: English, Japanese
II. Observational studies (Review questions 2)
a) CQ: Predictive biomarker of cognitive decline in type 2 diabetes, MCI or dementia
b) Follow-up period: 6 months or more
c) Presentation language: English, Japanese
Search data sources: PubMed / MEDLINE, The Cochrane Library, Ichushi Web
Key exclusion criteria
none
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Satoh-Asahara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, Japan
TEL
075-641-9161
nsatoh@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Satoh-Asahara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, Japan
TEL
075-641-9161
Homepage URL
nsatoh@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee for human research at Kyoto Medical Center
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555, Japan
Tel
075-641-9161
nsato@kyotolan.hosp.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 | 11 | 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
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
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, if there is an existing systematic review of evidence showing the association between dementia and diabetes, we will search for the latest findings and perform a new qualitative systematic review. In addition, a new qualitative systematic review will be conducted for items for which there is no existing systematic review. The systematic review in this study will be conducted in accordance with the "Priority Report Items for Systematic Review and Meta-Analysis (PRISMA Statement)".
Management information
Registered date
| 2020 | Year | 11 | Month | 19 | Day |
Last modified on
| 2020 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048512
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
