Saiseikai observational study of type 2 diabetics with microangiopathy in relation to macroangiopathy
Not Applicable
Recruiting
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000006247
- Lead Sponsor
- SDMac Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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