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Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00573950
Recruitment Status : Unknown
Verified December 2007 by Korea University Anam Hospital.
Recruitment status was:  Recruiting
First Posted : December 14, 2007
Last Update Posted : December 14, 2007
Information provided by:
Korea University Anam Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Metabolic Syndrome X Drug: cilostazol Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : December 2007
Estimated Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: Cilostazol
cilostazol group
Drug: cilostazol
50 mg two times a day for 2 weeks and then 100mg two times a day for 6 weeks
Other Name: pletaal

Placebo Comparator: Placebo
placebo group
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

Primary Outcome Measures :
  1. The effect on pulse wave velocity (PWV) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00573950

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Contact: Hee Young Kim, MD, PhD +82-2-920-5767
Contact: Sin Gon Kim, MD, PhD +82-2-920-5767

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Korea, Republic of
Korea Univerisity Anam Hospital Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Dong Kim    +82-2-920-6566   
Sponsors and Collaborators
Korea University Anam Hospital
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Principal Investigator: Sin Gon Kim, MD, PhD Korea University Anam Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sin Gon, Kim, Korea University Anam Hospital Identifier: NCT00573950    
Other Study ID Numbers: cilostaar
First Posted: December 14, 2007    Key Record Dates
Last Update Posted: December 14, 2007
Last Verified: December 2007
Keywords provided by Korea University Anam Hospital:
Type 2 Diabetes mellitus
Metabolic Syndrome
arterial stiffness
Pulse wave velocity
Additional relevant MeSH terms:
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Diabetes Mellitus
Metabolic Syndrome
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Insulin Resistance
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors