Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000387527
Ethics application status
Approved
Date submitted
31/08/2006
Date registered
4/09/2006
Date last updated
29/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to investigate the effect of taking fenofibrate on abnormal artery blood vessel function in people with Type 2 diabetes who are on best-dose treatment with statin medications.
Scientific title
Effect of micronised fenofibrate on endothelial dysfunction in subjects with Type 2 diabetes mellitus who are receiving optimal dose statin therapy.
Universal Trial Number (UTN)
Trial acronym
FENOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endothelial dysfunction in Type 2 Diabetes 1353 0
Condition category
Condition code
Metabolic and Endocrine 1444 1444 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 week crossover study comparing Fenofibrate 145mg orally daily or placebo in subjects with Type 2 Diabetes who are receiving optimal dose statin therapy
Intervention code [1] 1340 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1992 0
Brachial artery ultrasound: change in %FMD (flow mediated dilatation, endothelium-mediated).
Timepoint [1] 1992 0
Outcome measure undertaken at screening visit, weeks 0, 12, 16 and 28.
Secondary outcome [1] 3454 0
1. Forearm plethysmography: changes in forearm blood flow.
Timepoint [1] 3454 0
Outcome measures undertaken at screening visit.
Secondary outcome [2] 3455 0
2. Non-invasive measures of arterial stiffness (applanation tonometry and arterial pulse wave analysis: Small and larger artery compliance, Augmetnation index, and Pulse Wave Velocity).
Timepoint [2] 3455 0
Outcome measures undertaken at screening visit.
Secondary outcome [3] 3456 0
3. Biological markers.
Timepoint [3] 3456 0
Safety biochemistry undertaken at screening visit, weeks 0, 6, 12, 16, 22 and 28.

Eligibility
Key inclusion criteria
Type 2 diabetes aged 40-79 years; treatment with HMG-CoA reductase inhibitor (statin) at a stable dose for >=6 weeks; fasting LDL-cholesterol<2.5mmol/L; HDL-cholesterol <=1.5mmol/L; brachial artery FMD <=5.50% on screening ultrasound.
Minimum age
40 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria at screening: daytime insulin treatment (nocte insulin permitted); uncontrolled hyperglycaemia (HbA1c level >9.0%); uncontrolled hypertension (resting BP >150/90mmHg); total fasting cholesterol >=6.0mmol/L or triglycerides >=4.5mmol/L; treatment with other lipid-regulating medications (eg. fibrate, ezetimibe, cholestyramine, niacin, fish oil) or with CoQ supplements (within previous 6 weeks); current treatment with warfarin, nitrate or PDE5-inhibitor (eg. sildenafil); history of gall bladder disease; recent cardiovascular event (within previous 6 months); atrial fibrillation or other significant dysrhythmia; significantly abnormal renal (creatinine >150ummol/L), liver (ALT >3 times ULN) or thyroid function; Creatine Kinase >3 times ULN; significant anaemia; current smoker (previous 6 months); ethanol intake>21 standard drinks/week; significant substance abuse, psychiatric illness or likely poor compliance with study protocol; any other serious illness (eg. cancer) or likelihood of not completing study; technical difficulty with obtaining ultrasound scan of sufficient quality; weight>150kg.

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)
Sequencially numbered boxes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence generated by computer using SAS PROC-PLAN software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
subjects, study nurse, investigator and data analyst
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1582 0
University
Name [1] 1582 0
School of Medicine and Pharmacology
Country [1] 1582 0
Australia
Primary sponsor type
Individual
Name
Professor Gerald Watts
Address
Schoool of Medicine and Pharmacology, Royal Perth Hospital Unit, University of Western Australia, P O Box X2213, Perth, WA 6847
Country
Australia
Secondary sponsor category [1] 1389 0
None
Name [1] 1389 0
None
Address [1] 1389 0
Country [1] 1389 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3007 0
School of Medicine and Pharmacology, Royal Perth Hospital Unit, University of Western Australia
Ethics committee address [1] 3007 0
Ethics committee country [1] 3007 0
Australia
Date submitted for ethics approval [1] 3007 0
Approval date [1] 3007 0
12/04/2006
Ethics approval number [1] 3007 0
EC2006/091

Summary
Brief summary
People with diabetes and atherogenic dyslipidaemia who are treated with statin medication may still be at increased risk of cardiovascular disease and may require combination lipid regulating therapy to further reduce their risk. Endothelial dysfunction and increased arterial stiffness are present in early diabetic vascular disease and may be useful surrogate endpoints for cardiovascular risk. This 30 week, randomised double-blinded crossover study in 25 participants with diabetes who have endothelial dysfunction despite optimal statin therapy, aims to investigate whether combination therapy with micronised fenofibrate 145mg with no-food-effect orally once daily compared to matching placebo improves endothelial dysfunction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27947 0
Address 27947 0
Country 27947 0
Phone 27947 0
Fax 27947 0
Email 27947 0
Contact person for public queries
Name 10529 0
Sandra Hamilton
Address 10529 0
School of Medicine and Pharmacology
Royal Perth Hospital
Level 3
Rear 50 Murray Street
Perth WA 6001
Country 10529 0
Australia
Phone 10529 0
+61 8 92240318
Fax 10529 0
+61 8 92240243
Email 10529 0
[email protected]
Contact person for scientific queries
Name 1457 0
Professor Gerald Watts
Address 1457 0
School of Medicine and Pharmacology
Royal Perth Hospital
Level 4
Rear 50 Murray Street
Perth WA 6001
Country 1457 0
Australia
Phone 1457 0
+61 8 92240252
Fax 1457 0
+61 8 92240246
Email 1457 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.