UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000516 |
|---|---|
| Receipt number | 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 09:44:19 |
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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
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
hayashi@med.nagoya-u.ac.jp
Sponsor or person
Institute
AMED
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000624
