Effect of micronised fenofibrate on endothelial dysfunction in subjects with Type 2 diabetes mellitus who are receiving optimal dose statin therapy.

Professor Gerald Watts0 个研究点目标入组 25 人开始时间: 2006年9月4日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Type 2 diabetes aged 40-79 years; treatment with HMG-CoA reductase inhibitor (statin) at a stable dose for >=6 weeks; fasting LDL-cholesterol<2.5mmol/L; HDL-cholesterol <=1.5mmol/L; brachial artery FMD <=5.50% on screening ultrasound.

•Exclusion criteria at screening: daytime insulin treatment (nocte insulin permitted); uncontrolled hyperglycaemia (HbA1c level >9.0%); uncontrolled hypertension (resting BP >150/90mmHg); total fasting cholesterol >=6.0mmol/L or triglycerides >=4.5mmol/L; treatment with other lipid-regulating medications (eg. fibrate, ezetimibe, cholestyramine, niacin, fish oil) or with CoQ supplements (within previous 6 weeks); current treatment with warfarin, nitrate or PDE5-inhibitor (eg. sildenafil); history of gall bladder disease; recent cardiovascular event (within previous 6 months); atrial fibrillation or other significant dysrhythmia; significantly abnormal renal (creatinine >150ummol/L), liver (ALT >3 times ULN) or thyroid function; Creatine Kinase >3 times ULN; significant anaemia; current smoker (previous 6 months); ethanol intake>21 standard drinks/week; significant substance abuse, psychiatric illness or likely poor compliance with study protocol; any other serious illness (eg. cancer) or likelihood of not completing study; technical difficulty with obtaining ultrasound scan of sufficient quality; weight>150kg.

发起方

Professor Gerald Watts