Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness

Phase 4

• Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome X
• Interventions: Drug: Placebo; Drug: cilostazol

• Registration Number: NCT00573950
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-12
• Study Start: 2007-12
• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-13
• Last Update Submitted: 2007-12-13
• Study First Posted: 2007-12-14
• Last Update Posted: 2007-12-14
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo group
Cilostazol	cilostazol	cilostazol group

Primary Outcome Measures

Name	Time	Method
The effect on pulse wave velocity (PWV)	8 weeks

Secondary Outcome Measures

Name	Time	Method
the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP	8 weeks

Trial Locations

Locations (1)

Korea Univerisity Anam Hospital; 🇰🇷 Seoul, Korea, Republic of