Carotid Atherosclerosis, Type 2 Diabetes Mellitus
Conditions
Brief summary
To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in patients with type 2 diabetes mellitus
Interventions
DRUGCilostazol
Cilostazol 200 mg/day
DRUGAspirin
Aspirin 100 mg/day
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age between 30 and 80 years * Patients with type 2 diabetes on treatment (HbA1c 6.0-11.0%) * Carotid plaque on 3D ultrasound
Exclusion criteria
* Acute bleeding or bleeding tendency * Diagnosed with heart failure * Suggestive of ischemia on ECG * Uncontrolled hypertension * Recently diagnosed with peptic ulcer disease * Taking other antiplatelet agents * Hypersensitivity to salicylic acid * Aspirin induced asthma * Severe kidney, liver, heart disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of carotid artery atherosclerosis | 6 months | Plaque composition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of carotid artery atherosclerosis 1 | 6 months | Changes in carotid intima-media thickness after treatment |
| Change of carotid artery atherosclerosis 2 | 6 months | Changes in carotid artery stenosis after treatment |
| Change of carotid artery atherosclerosis 3 | 6 months | Plaque volume in carotid artery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Glucose metabolism 1 | 6 months | HOMA-Insulin Resistance |
| Diabetic complication | 6 months | Albuminuria |
| Glucose metabolism 2 | 6 months | HbA1c |
| Body composition | 6 months | Body fat mass and percent |
Countries
South Korea
Outcome results
None listed