CompletedPhase 4ACTRN12614001086651
Effects of Fenofibrate on Intramyocardial Triglyceride Content and Left Ventricular Myocardial Function in patients with Type 2 Diabetes and Hypertriglyceridemia
Sponsor
Dr Arnold Ng
Enrollment
60 participants
Start Date
Jun 15, 2014
Study Type
Interventional
Conditions
Summary
This is a single-centre, randomized, double-blind, placebo-controlled clinical trial. Participants will be randomized to receive fenofibrate (145mg daily for 6 months) or placebo in a parallel group, double blind design. Participants will undergo a cardiac MRI, Adenosine stress MRI perfusion, echocardiography and ECG at baseline and 6 months.
Eligibility
Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss
Inclusion Criteria2
- Type 2 diabetes
- Hypertriglyceridemia
Exclusion Criteria5
- Atrial fibrillation
- Current use of any fenofibrate or related fibrates
- Contraindication to fenofibrate including: liver impairment demonstrated by abnormal liver function tests (greater than or equal to 3 times normal upper limit), chronic renal failure (eGFR <60mL/min), symptomatic gallbladder disease, myopathy/myositis (elevation of CK > 5 times upper limit of normal)
- Contraindication to MRI including use of Gadolinium contrast
- Current enrolment in any other drug trial
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Interventions
Daily oral administration of 145mg of fenofibrate for 6 months. Drug tablet return will monitor adherence.
Daily oral administration of 145mg of fenofibrate for 6 months. Drug tablet return will monitor adherence.
Locations(1)
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ACTRN12614001086651
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