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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12614001086651 |
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Date of registration:
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10/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Fenofibrate on Intramyocardial Triglyceride Content and Left Ventricular Myocardial Function in patients with Type 2 Diabetes and Hypertriglyceridemia
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Scientific title:
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Effects of Fenofibrate on Intramyocardial Triglyceride Content and Left Ventricular Myocardial Function in patients with Type 2 Diabetes and Hypertriglyceridemia |
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Date of first enrolment:
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15/06/2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12614001086651.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Phase 4
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Arnold Ng
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Address:
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Princess Alexandra Hospital, The University of Queensland
199 Ipswich Road, Woolloongabba, QLD 4102
Australia |
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Telephone:
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61731762111 |
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Email:
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uqcng6@uq.edu.au |
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Affiliation:
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Name:
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Dr Arnold Ng
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Address:
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Princess Alexandra Hospital, The University of Queensland
199 Ipswich Road, Woolloongabba, QLD 4102
Australia |
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Telephone:
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61731762111 |
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Email:
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uqcng6@uq.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Type 2 diabetes;Hypertriglyceridemia;
Type 2 diabetes
Hypertriglyceridemia
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Cardiovascular - Other cardiovascular diseases
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Metabolic and Endocrine - Diabetes
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Intervention(s)
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Daily oral administration of 145mg of fenofibrate for 6 months. Drug tablet return will monitor adherence.
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Primary Outcome(s)
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Intramyocardial triglyceride content by MRI. [6 months post commencement of drug/placebo.]
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Myocardial deformation by speckle tracking echocardiography.[6 months post commencement of drug/placebo.]
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Secondary Outcome(s)
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Intrahepatic triglyceride level by MRI.[6 months post commencement of drug/placebo.]
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Source(s) of Monetary Support
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National Health and Medical Research Council (NHMRC)
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Ethics review
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Status: Approved
Approval date:
Contact:
Metro South Human Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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