NCT00573950Unknown4 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The effect on pulse wave velocity (PWV)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes patients with metabolic syndrome criteria of Asian-Pacific ATP III guideline
- •Type 2 diabetes (at least 1 criteria below)
- •fasting blood glucose ≥ 126 mg/dL
- •postprandial 2hour glucose ≥ 200 mg/dL
- •random blood glucose ≥ 200 mg/dL with typical diabetes symptoms
- •Metabolic syndrome : Asian-Pacific ATP III guideline
- •Fasting blood glucose ≥ 110 mg/dL, or previously diagnosed type 2 diabetes
- •systolic and/or diastolic blood pressure ≥130/85 mmHg, or treatment of previously diagnosed hypertension
- •Triglyceride ≥ 150 mg/dL, or Specific treatment for this lipid abnormality
- •HDL-cholesterol < 40 mg/dL for men and < 50 mg/dL for women, or Specific treatment for this lipid abnormality
- •Waist circumference ≥ 90 for men and ≥ 80 for women
排除标准
- •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
研究组 & 干预措施
Cilostazol
Experimental
cilostazol group
干预措施: cilostazol (Drug)
Placebo
Placebo Comparator
placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
The effect on pulse wave velocity (PWV)
时间窗: 8 weeks
次要结局
- the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP(8 weeks)
研究者
研究点 (1)
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