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

Phase 4

Completed

• Conditions: Type 2 diabetes; Hypertriglyceridemia; Cardiovascular - Other cardiovascular diseases; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12614001086651
• Lead Sponsor: Dr Arnold Ng

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intramyocardial triglyceride content by MRI. [6 months post commencement of drug/placebo.];Myocardial deformation by speckle tracking echocardiography.[6 months post commencement of drug/placebo.]

Secondary Outcome Measures

Name	Time	Method
Intrahepatic triglyceride level by MRI.[6 months post commencement of drug/placebo.]