Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness - Full Text View

Sponsor:	Korea University Anam Hospital
Information provided by:	Korea University Anam Hospital
ClinicalTrials.gov Identifier:	NCT00573950

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
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:

MedlinePlus related topics: Diabetes Metabolic Syndrome

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
Cilostazol: Experimental cilostazol group	Drug: cilostazol 50 mg two times a day for 2 weeks and then 100mg two times a day for 6 weeks
Placebo: Placebo Comparator 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:	Korea University Anam Hospital ( Sin Gon, Kim )
Study ID Numbers:	cilostaar
Study First Received:	December 13, 2007
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00573950 History of Changes
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:

Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Neuroprotective Agents
Hyperinsulinism
Fibrin Modulating Agents
Pathologic Processes
Syndrome
Therapeutic Uses
Cilostazol
Disease
Metabolic Diseases

Metabolic Syndrome X
Diabetes Mellitus
Endocrine System Diseases
Anti-Asthmatic Agents
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Autonomic Agents
Diabetes Mellitus, Type 2
Platelet Aggregation Inhibitors
Insulin Resistance
Peripheral Nervous System Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010