UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047927 |
|---|---|
| Receipt number | R000045517 |
| Scientific Title | Asahi Diabetes Gerontology Study |
| Date of disclosure of the study information | 2022/07/03 |
| Last modified on | 2022/06/02 15:14:14 |
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Basic information
Public title
Asahi Diabetes Gerontology Study
Acronym
Asahi Diabetes Gerontology Study (Asahi-g study)
Scientific Title
Asahi Diabetes Gerontology Study
Scientific Title:Acronym
Asahi Diabetes Gerontology Study (Asahi-g study)
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the reality of cognitive dysfunction and sarcopenia in diabetes mellitus and to elucidate the relationship between diabetes care, blood glucose fluctuation pattern and cognitive dysfunction.
Basic objectives2
Others
Basic objectives -Others
Observational epidemiological study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Cognitive function
mild cognitive dysfunction: Montreal cognitive assessment (MoCA-J)score, 25point or less
category I: the Dementia Assessment Sheet for Community-based Integrated Care System-8 items (DASC8)score, 10point or less
category II: DASC8 score, 11 to 16point
category III score, 17point or greater
2.sarcopenia: grip strength male 28kg or less, female 18kg or less, Skeletal Muscle Mass Index (SMI) male 7.0 kg/m 2 or less, female 5.7 kg/m 2 or less
Key secondary outcomes
1.all cause mortality
2.Complication:retinopathy, nephropathy, neuropathy, cardiovascular disease, stroke
3. Activities of daily living
4. Medication adherence
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
Type 1 and type 2 diabetes mellitus
Key exclusion criteria
1.Patient without diabetes
2.Impared glucose tolerance
3.other typed of diabetes mellitus due to specific causes
4.Gestational diabetes
5.Overt diabetes in pregnancy
6.Patient who are difficult to judge whether to participate in the study
7. Patient judged inappropriate for the doctor in charge
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Kasuga |
Organization
The institute of Medical Science, Asahi Life Foundation
Division name
Director
Zip code
1030002
Address
2-2-6 Nihonbashibakurocho, Chuo-ku,Tokyo
TEL
0336395501
m-kasuga@asahi-life.or.jp
Public contact
Name of contact person
| 1st name | Tazu |
| Middle name | |
| Last name | Tahara |
Organization
The institute of Medical Science, Asahi Life Foundation
Division name
Division of Diabetes and Metabolism
Zip code
1030002
Address
2-2-6 Nihonbashibakurocho, Chuo-ku,Tokyo
TEL
0336395501
Homepage URL
t-tahara@asahi-life.or.jp
Sponsor or person
Institute
The institute of Medical Science, Asahi Life Foundation
Institute
Department
Personal name
Funding Source
Organization
The institute of Medical Science, Asahi Life Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institute of Medical Science, Asahi Life Foundation
Address
2-2-6 Nihonbashibakurocho, Chuo-ku,Tokyo
Tel
0336395501
t-sumida@asahi-life.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
| 2022 | Year | 07 | Month | 03 | 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
603
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
| 2019 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 24 | 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
The blood glucose pattern is assessed by flush glucose monitoring.
Management information
Registered date
| 2022 | Year | 06 | Month | 02 | Day |
Last modified on
| 2022 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045517
| Research Plan | |
|---|---|
| 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 |
