Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001086651
Ethics application status
Approved
Date submitted
2/10/2014
Date registered
10/10/2014
Date last updated
25/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Fenofibrate on Intramyocardial Triglyceride Content and Left Ventricular Myocardial Function in patients with Type 2 Diabetes and Hypertriglyceridemia
Scientific title
Effects of Fenofibrate on Intramyocardial Triglyceride Content and Left Ventricular Myocardial Function in patients with Type 2 Diabetes and Hypertriglyceridemia
Secondary ID [1] 285432 0
Nil
Universal Trial Number (UTN)
U1111-1162-5325
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 293192 0
Hypertriglyceridemia 293228 0
Condition category
Condition code
Cardiovascular 293467 293467 0 0
Other cardiovascular diseases
Metabolic and Endocrine 293498 293498 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily oral administration of 145mg of fenofibrate for 6 months. Drug tablet return will monitor adherence.
Intervention code [1] 290361 0
Treatment: Drugs
Comparator / control treatment
Placebo tablets. The frequency and duration of use will also be identical to the active drug.
Control group
Placebo

Outcomes
Primary outcome [1] 293288 0
Intramyocardial triglyceride content by MRI.
Timepoint [1] 293288 0
6 months post commencement of drug/placebo.
Primary outcome [2] 293317 0
Myocardial deformation by speckle tracking echocardiography.
Timepoint [2] 293317 0
6 months post commencement of drug/placebo.
Secondary outcome [1] 310728 0
Intrahepatic triglyceride level by MRI.
Timepoint [1] 310728 0
6 months post commencement of drug/placebo.

Eligibility
Key inclusion criteria
1. Type 2 diabetes
2. Hypertriglyceridemia
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Trial participants who meet the inclusion/exclusion criteria and provide Informed Consent. Allocation concealment is performed by sealed opaque envelopes. Fenofibrate/Placebo tablets will be provided in numbered containers. Central randomization is performed via a central computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The patients will be allocated to treatment groups by use of block randomization with strata defined by gender, each with separate computer-generated treatment allocation sequences with permuted block sizes in random order. All trial staff, investigators and participants are blinded to the randomization schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2014
Actual
15/06/2014
Date of last participant enrolment
Anticipated
Actual
31/12/2016
Date of last data collection
Anticipated
Actual
31/12/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3035 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 8761 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 290039 0
Government body
Name [1] 290039 0
National Health and Medical Research Council (NHMRC)
Country [1] 290039 0
Australia
Primary sponsor type
Individual
Name
Dr Arnold Ng
Address
Princess Alexandra Hospital, The University of Queensland
199 Ipswich Road, Woolloongabba, QLD 4102
Country
Australia
Secondary sponsor category [1] 288730 0
Commercial sector/Industry
Name [1] 288730 0
Abbott
Address [1] 288730 0
32-34 Lord St
Botany, NSW 2019
Locked Bag 5016
Botany, NSW 1455
Country [1] 288730 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291750 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 291750 0
Princess Alexandra Hospital
199 Ipswich Road, Woolloongabba, QLD 4102
Ethics committee country [1] 291750 0
Australia
Date submitted for ethics approval [1] 291750 0
Approval date [1] 291750 0
20/11/2012
Ethics approval number [1] 291750 0
HREC/12/QPAH/478

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51846 0
Dr Arnold Ng
Address 51846 0
Princess Alexandra Hospital, The University of Queensland
199 Ipswich Road, Woolloongabba, QLD 4102
Country 51846 0
Australia
Phone 51846 0
61731762111
Fax 51846 0
Email 51846 0
[email protected]
Contact person for public queries
Name 51847 0
Dr Arnold Ng
Address 51847 0
Princess Alexandra Hospital, The University of Queensland
199 Ipswich Road, Woolloongabba, QLD 4102
Country 51847 0
Australia
Phone 51847 0
61731762111
Fax 51847 0
Email 51847 0
[email protected]
Contact person for scientific queries
Name 51848 0
Dr Arnold Ng
Address 51848 0
Princess Alexandra Hospital, The University of Queensland
199 Ipswich Road, Woolloongabba, QLD 4102
Country 51848 0
Australia
Phone 51848 0
61731762111
Fax 51848 0
Email 51848 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.