Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness in Type 2 Diabetes Patient With Metabolic Syndrome (Randomized, Double-Blind, Placebo-Controled, Cross-Over Study)

Conditions
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Diabetes Mellitus, Type 2, Metabolic Syndrome X

Intervention / Treatment
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* Drug: cilostazol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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) fasting blood glucose ≥ 126 mg/dL postprandial 2hour glucose ≥ 200 mg/dL random blood glucose ≥ 200 mg/dL with typical diabetes symptoms Metabolic syndrome : Asian-Pacific ATP III guideline Fasting blood glucose ≥ 110 mg/dL, or previously diagnosed type 2 diabetes systolic and/or diastolic blood pressure ≥130/85 mmHg, or treatment of previously diagnosed hypertension Triglyceride ≥ 150 mg/dL, or Specific treatment for this lipid abnormality HDL-cholesterol < 40 mg/dL for men and < 50 mg/dL for women, or Specific treatment for this lipid abnormality 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cilostazol<br>cilostazol group | Drug: cilostazol<br>* 50 mg two times a day for 2 weeks and then 100mg two times a day for 6 weeks<br>* Other names: pletaal;|
| Placebo Comparator: Placebo<br>placebo group | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect on pulse wave velocity (PWV) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cilostazol, Type 2 Diabetes mellitus, Metabolic Syndrome, adipocytokines, arterial stiffness, Pulse wave velocity