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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040908


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name