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

Professor Gerald Watts0 sites25 target enrollmentSeptember 4, 2006

Overview

No summary available.

Registry

who.int

Start Date

September 4, 2006

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Professor Gerald Watts

•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.