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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000516
Receipt No. R000000624
Scientific Title Japanese Research of Cholesterol and Diabetes Mellitus
Date of disclosure of the study information 2006/11/10
Last modified on 2017/11/15

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Basic information
Public title Japanese Research of Cholesterol and Diabetes Mellitus
Acronym Japan CDM
Scientific Title Japanese Research of Cholesterol and Diabetes Mellitus
Scientific Title:Acronym Japan CDM
Region
Japan

Condition
Condition Diabetics and the patients with impaired glucose tolerance
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The evaluation of various drugs such as anti-hyperlipidemic drugs effects on the prevention of the diabetic caridiovascular diseases
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Onset, admission and death of ischemic heart disease or cerebrovascular diseases. Total death
Key secondary outcomes Onset, admission and death of congestive heart failure or arteriosclerosis obliterance. Onset of dementia. Death of other cause

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Type II diabetics or patients with impoired glucose tolerance (diagnosed by Japanese Diabets Society) 2) Agreement of the study through informed concent 3) Out clinic patients with independent ADL without dementia 4) The patients who consult regularly attending physicans and take drug prescription.
Key exclusion criteria 1) Type I diabetics or diabetics of secondary diabetes 2) The patients who sufferred myocardial infarction, cerebellar infarction or arteriosclerosis thrombosis within 3months before regsitration. 3) inebriety 4) gravida, the patients may be pregnant 5) patients suffering symptomatic heart failure 6) patients suffering severe hepatopathy 7) patients suffering renal failure 8) patients suffering evident malignancy 9) patients who attending physician admitted to be inadequate for the study
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Assistant Prof.and Lecurer Toshio Hayashi
Organization Nagoya University Graduate School of Medicine
Division name School of Health Sciences
Zip code
Address 1-1-20 Daiko-Minami Highashi-ku, Nagoya City
TEL 052-719-1924
Email hayashi@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshio Hayashi
Organization Nagoya University Graduate School of Medicine
Division name School of Health Sciences
Zip code
Address 1-1-20 Daiko-Minami Highashi-ku, Nagoya City
TEL 052-719-1924
Homepage URL
Email hayashi@med.nagoya-u.ac.jp

Sponsor
Institute AMED
Institute
Department

Funding Source
Organization Japanese Ministry of welfare and labor
Organization
Division
Category of Funding Organization Japanese Governmental office
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 日本全国40病院 名古屋大学、北海道大学、東北大学、筑波大学,千葉大学、浜松医科大学、神戸大学、広島大学各医学部附属病院他、

Other administrative information
Date of disclosure of the study information
2006 Year 11 Month 10 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
Intermediate results
1) Importance of lipid levels in elderly diabetic individuals: baseline characteristics and 1-year survey of cardiovascular events. Hayashi T,  Iguchi A et al. Japan CDM group. Circ J. 2008;72:218-25
2) Low HDL cholesterol is associated with the risk of stroke in elderly diabetic individuals: changes in the risk for atherosclerotic diseases at various ages.
Hayashi T, Iguchi A et al.; Japan CDM Group.
Diabetes Care. 2009;32:1221-3
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
2004 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2004 Year 09 Month 30 Day
Last follow-up date
2019 Year 11 Month 01 Day
Date of closure to data entry
2019 Year 12 Month 30 Day
Date trial data considered complete
2020 Year 01 Month 30 Day
Date analysis concluded
2020 Year 05 Month 30 Day

Other
Other related information Investigation
Age, Birthday, Sex, Date of first medical examination On registration Diabetes Mellitus Date of diagnosis, type of DM, chorological medical treatment, Fasting plasma glucose, Glycohemoglobin A1C, Detailed information of present medical treatment (for example, the kind and dose of oral medications), Body weight, Body height, west size of navel level, Complication (Stage of Renopathy, Neuropathy, and Retinopathy) Hyperlipidemia Date of diagnosis, type of hyperlipidemia, chorological medical treatment, Fasting plasma lipid levels, detailed information of present medical treatment (for example, the kind and dose of oral medications), Hypertension Blood pressure, medical treatment of hypertension Others Hyperuricemia, History of smoking Event Fatal event Date of diagnosis and date of death, Diabetes related death (AMI, sudden death, Cerebrovascular disease, Renal failure, others) Diabetes non-related death (accident, neoplasm, pneumonia, others) Nonfatal event Date of diagnosis, Diabetes related (AMI, angina pectoris, intervention, heart failure with admission, Cerebrovascular disease, Arteriosclerosis obliterance with symptom) Detailed information of ischemic heart or cerebrovascular event

Management information
Registered date
2006 Year 11 Month 07 Day
Last modified on
2017 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000624

Research Plan
Registered date File name
2017/11/15 糖尿病の標準的治療開発概要1711B.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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