Effects of Fenofibrate on Intramyocardial Triglyceride Content and Left Ventricular Myocardial Function in patients with Type 2 Diabetes and Hypertriglyceridemia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001086651

Enrollment

Registered

2014-10-10

Start date

2014-06-15

Completion date

2016-12-31

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

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.

Interventions

Daily oral administration of 145mg of fenofibrate for 6 months. Drug tablet return will monitor adherence.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Type 2 diabetes 2. Hypertriglyceridemia

Exclusion criteria

1. Atrial fibrillation 2. Current use of any fenofibrate or related fibrates 3. 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) 4. Contraindication to MRI including use of Gadolinium contrast 5. Current enrolment in any other drug trial

Outcome results