Type 2 Diabetes Mellitus
Conditions
Keywords
cardiovascular disease, atherosclerosis
Brief summary
This study evaluates the more suitable treatment for the prevention of vascular complications in diabetes patents who were at high cardiovascular risk group by comparing the platelet aggregation inhibitory effect of aspirin and cilostazol.
Detailed description
Diabetes is a dangerous disease with high risk of vascular complications. Thus, to prevent these vascular complication, antithrombotic drug may be administered. Representative antithrombotic agents are aspirin and cilostazol. However, recent studies suggested that aspirin did not have sufficient effect to prevent vascular complications of diabetes. For that reason, it have been reported that antithrombotic effects of aspirin were falling in diabetes patients, so-called 'aspirin resistance. On the other hand, cilostazol used as the control drug inhibits atherosclerosis in diabetes patients in the studies of Asia including Korea, and it is effective to inhibit the risk of various cardiovascular disease. Therefore, cilostazol is likely to use drugs as substitute for aspirin therapy.
Interventions
DRUGCilostazol
Cilostazol sustained release capsule is new drugs developed by Otsuka Korea. This drugs have platelet aggregation inhibiting action, peripheral vasodilating action and endothelial function improving action.
DRUGAcetylsalicylic acid
Aspirin may prevent coronary thrombosis in patients with cardiovascular event risk factors, such as ischemic heart disease family history, hypertension, diabetes mellitus, dyslipidemia and obesity.
Sponsors
Asan Medical Center
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Who have one more following risk factor: * Family history of cardiovascular disease * Hypertension * Smoking History * Dyslipidemia * Albuminuria * Who do not have high risk of bleeding * Who stop taking Cilostazol or Aspirin before randomized period 1months or * Who have never taken the drugs
Exclusion criteria
* Type 1 diabetes mellitus, gestational diabetes * Who with history of macrovascular complication including cardiovascular disease, cerebrovascular disease and peripheral vascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| platelet reactivity testing | Change from Baseline 'platelet reactivity testing(Aspirin reaction units and platelet function testing-100) at 14 days | Blood sampling is collected at baseline and after taking each drugs 14 days, in the fasting state . The rate of Aspirin reaction units(ARU) change compared baseline is measured through Verify Now. The rate of platelet aggregation(seconds) dut to collagen, epinephrine was compared through the platelet function testing-100. 1. Verify Now(ARU): It is a test developed to monitor the platelet aggregation inhibitory effects of anti-platelet drugs which used to prevent thrombosis and relapse it. By measuring the light transmission change, it outputs result to the aspirin response units(ARU) 2. Platelet function testing-100: platelet function analyser The cartridge membrane is coated by collagen as initial matrix for platelet adhesion. When platelet adhere to the collagen, it takes place the first physical stimulation. Then, another membrane component, Adenosine diphosphate induces platelet aggregation. The analysis equipment is measuring CT(closing time) in seconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observation of Clinical laboratory data(total cholesterol, HDL, LDL and triglyceride | Change from baseline total cholesterol, HDL, LDL and triglyceride, hsCRP, cluster of designation antigen 40, ligand, Dipeptidyl peptidase-4 enzyme activity, total and active glucagon like peptide-1' at 14 days. | The rate of lipid profile(total cholesterol, HDL, LDL and triglyceride) change which is cardiovascular risk factors and diabetes mellitus complication indicators change are measured at baseline and after taking each drugs for 14 days. Thus, the effect of each drugs preventing complication in patients with diabetes mellitus may be analyzed. \- total cholesterol(mg/dL)/ HDL(mg/dL)/ LDL(mg/dL)/ triglyceride(mg/dL)/ hsCRP(mg/dL)/ cluster of designation antigen 40(mg/dL)/ Dipeptidyl peptidase-4 enzyme activity(uM/ml)/ total and active glucagon like peptide-1(pmol/l) |
Contacts
Primary ContactJi Hyun Kim, Fellow
Backup ContactCheol Young Park, Professor
Outcome results
None listed