Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness

Verified by: Korea University Anam Hospital, December 2007
First Received: December 13, 2007 | Last Updated: December 13, 2007 | Phase: Phase 4 | Start Date: December 2007
Overall Status: Recruiting | Estimated Enrollment: 48
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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...

Brief Summary

Official Title: “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)”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: cilostazol
    • 50 mg two times a day for 2 weeks and then 100mg two times a day for 6 weeks
  • Drug: Placebo
    • 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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Cilostazol
    • cilostazol group
  • Placebo Comparator: Placebo
    • placebo group

Outcome Measures for this Clinical Trial

Primary Measures

  • The effect on pulse wave velocity (PWV)
    • Time Frame: 8 weeks
      Safety Issue?: No

Secondary Measures

  • the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP
    • Time Frame: 8 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

- 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

    Gender Eligibility for this Clinical Trial: Both

    Minimum Age for this Clinical Trial: 18 Years

    Maximum Age for this Clinical Trial: 80 Years

    Are Healthy Volunteers Accepted for this Clinical Trial?: No

    Clinical Trial Investigator Information

    Lead Investigator: Korea University Anam Hospital Other

    Overall Clinical Trial Officials and Contacts

    Sin Gon Kim, MD, PhD Principal Investigator Korea University Anam Hospital  

    Overall Contact: Hee Young Kim, MD, PhD +82-2-920-5767 lynsette@korea.ac.kr

    Additional Information

    Information obtained from ClinicalTrials.gov on February 12, 2012

    Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00573950

    Study ID Number: cilostaar

    ClinicalTrials.gov Identifier: NCT00573950

    Health Authority: Korea: Food and Drug Administration

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