UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035911 |
|---|---|
| Receipt number | R000040908 |
| Scientific Title | Japan-Multidomain Intervention Trial for Prevention of Dementia in Older Adults with Diabetes. |
| Date of disclosure of the study information | 2019/02/19 |
| Last modified on | 2022/07/12 05:17:02 |
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Basic information
Public title
Japan-Multidomain Intervention Trial for Prevention of Dementia in Older Adults with Diabetes.
Acronym
J-MIND-Diabetes study
Scientific Title
Japan-Multidomain Intervention Trial for Prevention of Dementia in Older Adults with Diabetes.
Scientific Title:Acronym
J-MIND-Diabetes study
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus with mild cognitive impairment
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to identify wether multidomain intervention could prevent the progression of cognitive decline in older adults with type 2 diabetes mellitus classified into in category 2 according to the JGS/JDS Clinical Practice Guideline for the Treatment of Diabetes in the Elderly 2017.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in composite score of cognitive function from baseline to 18-month follow-up.
Key secondary outcomes
1) Change in composite score of cognitive function from baseline to 6-month follow-up.
2) Change in scores of each cognitive function from baseline to 6/18-month follow-up.
3) Change in Barthel Index and Lawton Index from baseleine to 6/18-month follow-up.
4) Change in status of frailty and sarcopenia from baseline to 6/18-month follow-up.
5) Change in the number of medications.
6) Cost-effectiveness.
7) Change in each result of comprehensive geriatric assement from baseline to 6/18-month follow-up.
8) Change in laboratory and urinary markers from baseline to 6/18-month follow-up.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Multidomain intervention including vascular risk factor management, exercise, diet and social engagement. Diabetes, hypertension, and dyslipidemia are treated according to their guidelines in Japan. Traning sessions are conducted. Nutritional advice is based on dietary guideline established by the JGD/JGS. For social engagement, going out is recommended. Subjects are requested to use a diary to record their diet, physical and social activity.
Interventions/Control_2
Usual care.
Text about prevention for dementia.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who
1) are diagnosed with type 2 diabetes mellitus
2) aged 70-85 at the time of enrollment
3) have no or slight impairment of basic acitivities of daily living (Barthel Index >= 80)
4) have cognitive impairment (MoCA-J < 26)
5) have MMSE score of 21-30
6) are outpatients or who have stable clinical corse for more than 4 weeks after their latest hospitalization or institutionalization and who have no need to change the medical examination classification during monitoring period.
7) are accompanied by a co-participant (study partner). The study partner must be physically and mentally healthy, contact the patient about once a week, and know how the patient lives. Preferably, the study partner should be able to make many visits together with the patient during the monitoring period.
8) have provided a written informed consent by subjects or their study partners.
Key exclusion criteria
1) Metabolic control is extremely poor (fasting plasma glucose level over 250 mg/dl; or urinay ketone bodies moderately positive above.
2) New hemorrahaging in the ocular fundus caused by proliferative retinopathy.
3) Renal failure.
4) Ischemic heart disease and cardiopulmonary disorders.
5) Presence of bone or joint disease.
6) Acute infectious disease.
7) Diabetes gangrene.
8) Severe autonomic neuropathy.
9) 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 decreased cognitive function due to head injury.
10) Any local lesion such as cerebral infarction(s) detected by CT or MRI before enrollment that can greatly affect the cognitive function
11) History of major depression, bipolar disorder, schizophrenia, or alcohol/drug abuse; current serious or unstable disease
12) Patients unsuitable for treatment due to vitamin B1/B12 and/or folate deficiency, syphilis, or thyroid dysfunction
13) Patients deemed ineligible for enrollment by the responsible researcher or co-researcher at each institution
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Sakurai |
Organization
National Center for Geriatrics and Gerontology
Division name
Center for Comprehensive Care and Research on Memory Disorders
Zip code
Address
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
TEL
0562-46-2311
tsakurai@ncgg.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Sakurai |
Organization
National Center for Geriatrics and Gerontology
Division name
Center for Comprehensive Care and Research on Memory Disorders
Zip code
Address
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
TEL
0562-46-2311
Homepage URL
https://www.j-mind-diabetes.jp
j-mind@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Center for Geriatrics and Gerontology and 16 institusions in Japan
Name of secondary funder(s)
National Center for Geriatrics and Gerontology
IRB Contact (For public release)
Organization
Address
Tel
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
国立研究開発法人国立長寿医療研究センターと全国16施設
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 19 | 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
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2019 | Year | 02 | Month | 18 | Day |
Last modified on
| 2022 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040908
