Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness

Korea University

Status and phase: Unknown; Phase 4

Conditions: Metabolic Syndrome X; Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: cilostazol

Study type: Interventional

Funder types: Other

Identifiers

NCT00573950

cilostaar

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Cilostazol

Experimental group

Description:

cilostazol group

Treatment:

Drug: cilostazol

Placebo

Placebo Comparator group

Description:

placebo group

Treatment:

Drug: Placebo