Saiseikai observational study of type 2 diabetics with microangiopathy in relation to macroangiopathy

Saiseikai observational study of type 2 diabetics with microangiopathy in relation to macroangiopathy - SDMac

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000006247

Enrollment

200

Registered

2011-09-01

Start date

2011-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactToshiyuki Takahashi

Tokyo Saiseikai Central Hospital Department of Cardiology

ttakahashi@saichu.jp03-3451-8211(ext2318)

Outcome results