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)

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

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