Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness
Information source: Korea University Anam Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2; Metabolic Syndrome X
Intervention: cilostazol (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Korea University Anam Hospital Official(s) and/or principal investigator(s):
Sin Gon Kim, MD, PhD, Principal Investigator, Affiliation: Korea University Anam Hospital
Overall contact:
Hee Young Kim, MD, PhD, Phone: +82-2-920-5767, Email: lynsette@korea.ac.kr
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: The effect on pulse wave velocity (PWV)
Secondary outcome: the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Hee Young Kim, MD, PhD, Phone: +82-2-920-5767, Email: lynsette@korea.ac.kr
Korea Univerisity Anam Hospital, Seoul 136-705, Korea, Republic of; Recruiting
Dong Kim, Phone: +82-2-920-6566, Email: ctcan@kumc.or.kr
Additional Information
Starting date: December 2007
Ending date: December 2008
Last updated: December 13, 2007
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