Diabetes Mellitus, Type 2, Metabolic Syndrome X
Conditions
Keywords
cilostazol, Type 2 Diabetes mellitus, Metabolic Syndrome, adipocytokines, arterial stiffness, Pulse wave velocity
Brief summary
Cilostazol is an antiplatelet agent used to reduce the symptoms of intermittent claudication. Cilostazol inhibits phosphodiesterase III (PDE III), which causes it to be a vasodilator and inhibitor of platelet aggregation. Recently there were report of beneficial effect of cilostazol like vasodilation, lipid metabolism, and cytokine production. But there were few clinical studies that support these effects of cilostazol. The purpose of this study is to evaluate the vasodilatory and anti-inflammatory effect of cilostazol presented by PWV and plasma adipocytokines.
Interventions
DRUGcilostazol
50 mg two times a day for 2 weeks and then 100mg two times a day for 6 weeks
DRUGPlacebo
Placebo tablet comparable to 50mg cilostazol two times a day for 2 weeks and then placebo tablet comparable to 100mg cilostazol two times a day for 6 weeks
Sponsors
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Eligible for study: 18 year and above, Gender eligible for study: both Inclusion Criteria:Type 2 diabetes patients with metabolic syndrome criteria of Asian-Pacific ATP III guideline * Type 2 diabetes (at least 1 criteria below) 1. fasting blood glucose ≥ 126 mg/dL 2. postprandial 2hour glucose ≥ 200 mg/dL 3. random blood glucose ≥ 200 mg/dL with typical diabetes symptoms * Metabolic syndrome : Asian-Pacific ATP III guideline 1. Fasting blood glucose ≥ 110 mg/dL, or previously diagnosed type 2 diabetes 2. systolic and/or diastolic blood pressure ≥130/85 mmHg, or treatment of previously diagnosed hypertension 3. Triglyceride ≥ 150 mg/dL, or Specific treatment for this lipid abnormality 4. HDL-cholesterol \< 40 mg/dL for men and \< 50 mg/dL for women, or Specific treatment for this lipid abnormality 5. Waist circumference ≥ 90 for men and ≥ 80 for women
Exclusion criteria
* Hypertensive patients with the use of ACE inhibitor or ARB * Hyperlipidemic patients with the use of statin or fenofibrate * Hepatic dysfunction * Chronic alcohol or drug abuse * Renal dysfunction * Heart failure * Patients who takes hormone replace therapy or steroid containing drugs * Patients who take drugs like anticoagulant (warfarin), anti-platelet agent (aspirin, ticlopidin), thrombolytic agent (urikinase, alteplase), prostaglandine E1 , drugs inhibit CYP3A4 or CYP2C19, or drugs become substrate of CYP3A4 * Patients who haves disease influencing the results of the study such as neurologic, digestive and neoplastic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect on pulse wave velocity (PWV) | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP | 8 weeks |
Countries
South Korea
Contacts
Primary ContactHee Young Kim, MD, PhD
Backup ContactSin Gon Kim, MD, PhD
Outcome results
None listed