UMIN-CTR Clinical Trial

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
Email	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
Email	j-mind@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

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
Email

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040908