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Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Korea University Anam Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT00573950
First received: December 13, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Metabolic Syndrome X
 Drug: cilostazol
Drug: Placebo
 Phase 4

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
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)

Resource links provided by NLM:

Drug Information available for: Cilostazol
U.S. FDA Resources

Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:
  • The effect on pulse wave velocity (PWV) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: December 2007
Estimated Study Completion Date: December 2008
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573950

Contacts
Contact: Hee Young Kim, MD, PhD +82-2-920-5767 lynsette@korea.ac.kr
Contact: Sin Gon Kim, MD, PhD +82-2-920-5767 k50367@korea.ac.kr

Locations
Korea, Republic of
Korea Univerisity Anam Hospital Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Dong Kim     +82-2-920-6566     ctcan@kumc.or.kr    
Sponsors and Collaborators
Korea University Anam Hospital
Investigators
Principal Investigator: Sin Gon Kim, MD, PhD Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Sin Gon, Kim, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT00573950     History of Changes
Other Study ID Numbers: cilostaar
Study First Received: December 13, 2007
Last Updated: December 13, 2007
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea University Anam Hospital:
cilostazol
Type 2 Diabetes mellitus
Metabolic Syndrome
 adipocytokines
arterial stiffness
Pulse wave velocity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Cilostazol
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
 Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 22, 2013