Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness

Diabetes Mellitus, Type 2 Clinical Trial

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)

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00573950
• Other study ID #: cilostaar
• Status: Unknown status
• Phase: Phase 4
• First received: December 13, 2007
• Last updated: December 13, 2007
• Start date: December 2007
• Est. completion date: December 2008

Study information

• Verified date: December 2007
• Source: Korea University Anam Hospital
• Contact: Hee Young Kim, MD, PhD
• Phone: +82-2-920-5767
• Email: lynsette[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 48
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Metabolic Syndrome X
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea Univerisity Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect on pulse wave velocity (PWV)		8 weeks
Secondary	the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP		8 weeks