UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000890 |
|---|---|
| Receipt number | R000001068 |
| Scientific Title | Japan Elderly Diabetes Intervention Study |
| Date of disclosure of the study information | 2007/11/22 |
| Last modified on | 2007/11/14 19:45:47 |
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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
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
Sponsor or person
Institute
Japan Foundation for Health and Aging
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001068
