UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006675 |
|---|---|
| Receipt number | R000007883 |
| Scientific Title | Additional prospective study for the prevention of diabetic macrovascular complications. |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2011/11/05 14:56:51 |
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Basic information
Public title
Additional prospective study for the prevention of diabetic macrovascular complications.
Acronym
Additional prospective study for MSDM
Scientific Title
Additional prospective study for the prevention of diabetic macrovascular complications.
Scientific Title:Acronym
Additional prospective study for MSDM
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparative and prospective study to compare occurrence of MA in groupes of better controlled (more than 4 factors)vs poor(less than 3 out of 7 factors)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kaplan-Meyer analysis for the appearance of MA according to the different controled state.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Analyze incidence of MA according to the different digree of metabolic control in total 7 risk factors.
Interventions/Control_2
Compare occurrence of MA in 2 different controled state.
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
Type 2 diabetes without MA.
Key exclusion criteria
Those who cannot pay periodical visit to the hospital and those who had recieved interventional treatment.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Harano |
Organization
Niseikai Center for Life-style related diseases
Division name
medicine
Zip code
Address
7-14-17 Niina Mino City
TEL
072-700-1135
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Niseikai Center for Life-style related diseases
Division name
medicine
Zip code
Address
TEL
072-700-1135
Homepage URL
Sponsor or person
Institute
MSDM(Additional prospective study)
Institute
Department
Personal name
Funding Source
Organization
JAPAN VASCULAR DISEASE 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 | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
| 1993 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1993 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2003 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 05 | Day |
Last modified on
| 2011 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007883
