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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016519
Receipt No. 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

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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
Email 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
Email rimei.nishimura@gmail.com

Sponsor
Institute The Japan Diabetes Society
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019014

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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