UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006247 |
|---|---|
| Receipt number | R000007393 |
| Scientific Title | Saiseikai observational study of type 2 diabetics with microangiopathy in relation to macroangiopathy |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2012/02/01 15:22:27 |
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Basic information
Public title
Saiseikai observational study of type 2 diabetics with microangiopathy in relation to macroangiopathy
Acronym
SDMac
Scientific Title
Saiseikai observational study of type 2 diabetics with microangiopathy in relation to macroangiopathy
Scientific Title:Acronym
SDMac
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association between diabetic microangiopathy and macroangiopathy by assessing the extent of macroangiopathy, including coronary artery disease, cerebral vascular disease, and peripheral artery disease, in type 2 diabetics with microangiopathy
Basic objectives2
Others
Basic objectives -Others
Observation
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Temporal changes of coronary plaque volume and calcium score, assessed by CT
2) Temporal changes of pericardial fat volume, assessed by CT
3) Atherosclerotic changes of carotid artery, assessed by intima-medial thickness
4) Atherosclerotic changes of peripheral artery, assessed by ankle-brachial index
5) Atherosclerotic changes of cerebral major arteries and microvascular lesion, assessed by MRI
Key secondary outcomes
Major adverse cardio-cerebrovascular event (MACCE) including 1) death from cardiovascular and cerebrovascular disease, 2) non-fatal myocardial infarction, 3) unstable angina requiring hospitalization, 4) heart failure requiring hospitalization, 5) non-fatal stroke, including transient ischemic attack, and 6) percutaneous intervention or bypass surgery for peripheral artery disease
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients with diabetic retinopathy or microalbuminuria, who have no history of typical angina and are followed up at our institution
Key exclusion criteria
1) Patients with a past history of coronary artery disease, stroke, peripheral artery disease, congestive heart failure, or neoplastic disease
2) Patients with persistent atrial fibrillation
3) Patients with severe chronic kidney disease (GFR, 30 ml/hr/1.73m2 or less)
4) No informed consent is obtained
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Nakagawa |
Organization
Tokyo Saiseikai Central Hospital
Division name
Department of Cardiology
Zip code
Address
1-4-17 Mita, Minato-ku, Tokyo
TEL
03-3451-8211(ext2318)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Takahashi |
Organization
Tokyo Saiseikai Central Hospital
Division name
Department of Cardiology
Zip code
Address
1-4-17 Mita, Minato-ku, Tokyo
TEL
03-3451-8211(ext2318)
Homepage URL
http://www.saichu.jp/
ttakahashi@saichu.jp
Sponsor or person
Institute
SDMac Study Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
東京都済生会中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 01 | Day |
Other
Other related information
In this prospective, observational study, asymptomatic type 2 diabetic patients with diabetic retinopathy or microalbuminuria who have no previous history of macrovascular disease undergo screening for macroangiopathy, in order to identify the progression of atherosclerosis and its potential predictors. The primary and secondary end-points are the progression of atherosclerosis and the major adverse cardio-cerebral vascular event, respectively.
Management information
Registered date
| 2011 | Year | 08 | Month | 29 | Day |
Last modified on
| 2012 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007393
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
