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.

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000387527

Acronym

FENOS

Enrollment

Registered

2006-09-04

Start date

2006-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

People with diabetes and atherogenic dyslipidaemia who are treated with statin medication may still be at increased risk of cardiovascular disease and may require combination lipid regulating therapy to further reduce their risk. Endothelial dysfunction and increased arterial stiffness are present in early diabetic vascular disease and may be useful surrogate endpoints for cardiovascular risk. This 30 week, randomised double-blinded crossover study in 25 participants with diabetes who have endothelial dysfunction despite optimal statin therapy, aims to investigate whether combination therapy with micronised fenofibrate 145mg with no-food-effect orally once daily compared to matching placebo improves endothelial dysfunction.

Interventions

12 week crossover study comparing Fenofibrate 145mg orally daily or placebo in subjects with Type 2 Diabetes who are receiving optimal dose statin therapy

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

40 Years to 79 Years

Healthy volunteers

Inclusion criteria

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

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.

Outcome results