A study to investigate the effect of taking fenofibrate on abnormal artery blood vessel function in people with Type 2 diabetes who are on best-dose treatment with statin medications.
- Conditions
- Endothelial dysfunction in Type 2 DiabetesMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12606000387527
- Lead Sponsor
- Professor Gerald Watts
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Brachial artery ultrasound: change in %FMD (flow mediated dilatation, endothelium-mediated).[Outcome measure undertaken at screening visit, weeks 0, 12, 16 and 28.]
- Secondary Outcome Measures
Name Time Method 1. Forearm plethysmography: changes in forearm blood flow.[Outcome measures undertaken at screening visit.];2. Non-invasive measures of arterial stiffness (applanation tonometry and arterial pulse wave analysis: Small and larger artery compliance, Augmetnation index, and Pulse Wave Velocity). [Outcome measures undertaken at screening visit.];3. Biological markers.[Safety biochemistry undertaken at screening visit, weeks 0, 6, 12, 16, 22 and 28.]