UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016519 |
|---|---|
| Receipt number | R000019014 |
| Scientific Title | Japan Diabetes Complication and its Prevention Prospective Study |
| Date of disclosure of the study information | 2015/02/16 |
| Last modified on | 2015/02/12 17:17:09 |
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Basic information
Public title
Japan Diabetes Complication and its Prevention Prospective Study
Acronym
JDCPstudy
Scientific Title
Japan Diabetes Complication and its Prevention Prospective Study
Scientific Title:Acronym
JDCPstudy
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the current status of management of people with diabetes in recent years, and to clarify the risk factors for the onset/progression of diabetes complications.
Basic objectives2
Others
Basic objectives -Others
epidemiologic study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nephropathy
The first period: consecutive 2 measured albuminuria in patients without microalbuminuria (urinary albumin/ creatinine ratio, 30mg/g Cr or greater)
The second period: appearance of overt proteinuria (urinary albumin/ creatinine ratio, 300mg/g Cr or greater), > 2-fold increases in serum creatinine, or initiation of dialysis in those with microalbuminuria.
Retinopathy
Progression of disease from simple, non-proliferative retinopathy to proliferative retinopathy or blindness
Neuropathy
Lower extremity amputation associated with peripheral neuropathy
Macroangiopathy
Ischemic heart disease (e.g. myocardial infraction, angina, cardiac revascularization), cerebrovascular disease (e.g. stroke, transient cerebral ischemic attack), heart failure, ASO, and lower extremity amputation (without peripheral neuropathy)
Periodontal disease
New appearance of probing depth [PD] 4mm or deeper or loss of a tooth due to periodontal disease
Surrogate endpoints
Gingival swelling, number of intact teeth, number of sites with clinical attachment level [CAL] 4 mm or greater, number of sites with bleeding on proving [BOP], maximum alveolar bone resorptions as assessed by orthopantomography
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) type 1&2 Diabetes
2) 40-< 75 years old
Key exclusion criteria
1) patients who can't see a doctor regularly
2) proliferative retinopathy
3) patients who undergo artificial dialysis
4) patients who is diagnosed as cancer in last 5 years
5) patients who is judged as isn't proper
Target sample size
6500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoko Tajima |
Organization
The Jikei University School of Medicine
Division name
an honorary professor
Zip code
Address
3-25-8 Nishi-Shimbashi Minato-ku, Tokyo
TEL
03-3433-1111
naokopgh@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rimei Nishimura |
Organization
The Jikei University School of Medicine
Division name
Diabetic tract medicine
Zip code
Address
3-25-8 Nishi-Shimbashi Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
rimei.nishimura@gmail.com
Sponsor or person
Institute
The Japan Diabetes Society
Institute
Department
Personal name
Funding Source
Organization
The Japan Diabetes Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2015 | Year | 02 | Month | 16 | Day |
Related information
URL releasing protocol
http://www.jds.or.jp/jdcp_study/download/
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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 04 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Now follow up for 10 years
Management information
Registered date
| 2015 | Year | 02 | Month | 12 | Day |
Last modified on
| 2015 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019014
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
