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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000890
Receipt No. R000001068
Scientific Title Japan Elderly Diabetes Intervention Study
Date of disclosure of the study information 2007/11/22
Last modified on 2007/11/14

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Basic information
Public title Japan Elderly Diabetes Intervention Study
Acronym J-EDIT
Scientific Title Japan Elderly Diabetes Intervention Study
Scientific Title:Acronym J-EDIT
Region
Japan

Condition
Condition Diabetes Mellitus in the Elderly
Classification by specialty
Endocrinology and Metabolism Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of multifactorial interventions on micro- and macrovacular complications, mortality, and prognosis of physical, cognitive, and psychological functions.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1.Fatal endpoints: diabetes-specific death including cardiovaslular death, and non-diabetes-specific death
2.Non-fatal endpoints: acute myocardial infarction, other IHDs, cerebrovascular disease, arterial peripheral vascular disease, diabetic gangrene, and the blindness due to diabetic retinopathy.
Key secondary outcomes Diabetic microangiopathy(reitinopathy, nephropathy,neuropathy), vitreous hemorrhage, congestive heart failure, and retinal photocoagulation.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intensive treatment group: HbA1c<6.5%, Blood preesure <130/85mmHg,Total cholesterol:<180mg/dl (If CHD is present), or <200mg/dl (If CHD is absent),Triglycerides<150mg/dl, HDL cholesterol>40mg/dl, and BMI<25.
Interventions/Control_2 Conventional treatment group: goals as attending doctors consider to be proper.
:at least fasting plasma glucose <200mg/dl or HbA1c<9.0%
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
85 years-old >
Gender Male and Female
Key inclusion criteria diabetic patients aged 65-84 years
both sexes
HbA1c 7.0% or greater
If HbA1c is between 7.0 and 7.5 %, the values of blood preesures, serum lipid, or BMI do not reach the goals of the treatment.
Key exclusion criteria type 1 diabetes
acute disease
malignancy
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Ito
Organization Tokyo Metropolitan Geriatric Hospital
Division name President
Zip code
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo173-0015, Japan
TEL 03-3964-1141
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Araki
Organization Tokyo Metropolitan Geriatric Hospital
Division name Division of Endocrinology
Zip code
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo173-0015, Japan
TEL 03-3964-1141
Homepage URL
Email

Sponsor
Institute Japan Foundation for Health and Aging
Institute
Department

Funding Source
Organization Japan Foundation for Health and Aging
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2007 Year 11 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2001 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date
2001 Year 03 Month 01 Day
Last follow-up date
2007 Year 09 Month 01 Day
Date of closure to data entry
2008 Year 09 Month 01 Day
Date trial data considered complete
2008 Year 12 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 11 Month 14 Day
Last modified on
2007 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001068

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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