CompletedPhase 3Phase 4ACTRN12606000387527

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.


Sponsor

Professor Gerald Watts

Enrollment

25 participants

Start Date

Aug 1, 2006

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 79 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether adding fenofibrate (a cholesterol medication) to existing statin therapy can improve blood vessel function in people aged 40-79 with type 2 diabetes. Participants must already be on a stable statin dose with well-controlled LDL cholesterol but low HDL (good) cholesterol.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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


Locations(1)

Australia

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ACTRN12606000387527