UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006244 |
|---|---|
| Receipt number | R000007391 |
| Scientific Title | Multiclinical Study for Diabetic Macrovascular complications(MSDM) |
| Date of disclosure of the study information | 2011/08/29 |
| Last modified on | 2011/08/31 15:47:44 |
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Basic information
Public title
Multiclinical Study for Diabetic Macrovascular complications(MSDM)
Acronym
MSDM
Scientific Title
Multiclinical Study for Diabetic Macrovascular complications(MSDM)
Scientific Title:Acronym
MSDM
Region
| Japan |
Condition
Condition
To clarify the clinical features of diabetic macroangiopathy in our country and to set up the control critelia for the multiple risk factors.
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clearify the clinical features of diabetic macroangiopathy(MA) and find out control critelia for the onset and progression of MA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Incidence and clinical features of MA and the relationship between MA and various riskfactors have been followed clinically in multiple facilities.
Key secondary outcomes
Relationship between MA and microvascular complications has been evaluated.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
type 2 diabetes with or without MA,who chan be followed periodically in out patient clinic.
Key exclusion criteria
those who can not visit clinic periodically or age above 80.
Brain hemorrhage was removed from CVD.
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Harano Yutaka |
Organization
Niseikai Centar for Lifestyle Deseases
Division name
Niseikai Centar for Lifestyle Deseases
Zip code
Address
7-14-17,Niina,Mino-City,OSAKA
TEL
072-700-1135
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
MSDM
Division name
Niseikai Centar
Zip code
Address
TEL
Homepage URL
yharano_life@hcn.zaq.ne.jp
Sponsor or person
Institute
MSDM
Institute
Department
Personal name
Funding Source
Organization
Adult Vascular Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2011 | Year | 08 | Month | 29 | 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
Completed
Date of protocol fixation
| 1990 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1990 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2001 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2006 | Year | 12 | Month | 01 | Day |
Other
Other related information
Registar tupe 2 diabetes with or without MA and follow the onset or progression of MA. Data of risk factors for MA were used around the date of onset or when diagnosis was made.
Management information
Registered date
| 2011 | Year | 08 | Month | 29 | Day |
Last modified on
| 2011 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007391
