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Trial registered on ANZCTR


Registration number
ACTRN12611001150932
Ethics application status
Approved
Date submitted
26/10/2011
Date registered
2/11/2011
Date last updated
2/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dyslipidaemia, Oxidative Stress And Arterial Wall Function In Non-Insulin Dependent Diabetes
Scientific title
A Double-Blind Randomised Placebo-Controlled Trial Of The Effects Of Fenofibrate And Coenzyme Q10 On Arterial Function In Type 2 Diabetic Subjects With Dyslipidaemia
Secondary ID [1] 273277 0
NHMRC Grant Project Number: 970154
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 279042 0
Dyslipidaemia 279089 0
Condition category
Condition code
Metabolic and Endocrine 279228 279228 0 0
Diabetes
Metabolic and Endocrine 279229 279229 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1.Fenofibrate 200mg/day orally
2.Coenzyme Q10 200mg/day orally
3.Fenofibrate 200mg/day plus Coezyme Q10 200mg/day orally
4.Placebo
All for 12 weeks
Intervention code [1] 283622 0
Treatment: Drugs
Comparator / control treatment
Placebo, microcellulose
Control group
Placebo

Outcomes
Primary outcome [1] 279858 0
Acetylcholine-stimulated forearm blood flow measured by strain gauge plethysmography
Timepoint [1] 279858 0
At baseline (week 0) and at week 12 after treatment randomisation
Secondary outcome [1] 294592 0
Hyperaemic response in forearm blood flow following venous occlusion measured by strain gauge plethysmography
Timepoint [1] 294592 0
At baseline (week 0) and at weeks 6 and 12 after treatment randomisation
Secondary outcome [2] 294593 0
Hyperaemic flow-mediated dilatation of the brachial artery following arterial occlusion measured by ultrasonography
Timepoint [2] 294593 0
At baseline (week 0) and at weeks 6 and 12 after treatment randomisation

Eligibility
Key inclusion criteria
Type 2 diabetes

Dyslipidaemia (fasting serum triglycaeride >1.8mmol/L or HDL-cholesterol <1.0mmol/L, with total cholesterol <6.5mmol/L and total cholesterol-to-HDL-cholesterol ratio >4)
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of antioxidant or lipid-regulating therapy, insulin, angiotensin-converting enzyme inhibitors, calcium antagonists or aspirin

Body mass index >40kg/m2

Uncontrolled hypertension (>160/90mmHg)

Serum creatinine >150umol/L

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 284108 0
Government body
Name [1] 284108 0
National Health and Medical Research Council
Address [1] 284108 0
GPO Box 1421
Canberra ACT 2601
Country [1] 284108 0
Australia
Primary sponsor type
Individual
Name
Professor Gerald F Watts
Address
University of Western Australia
School of Medicine and Pharmacology
Royal Perth Hospital Unit
GPO Box X2213
Perth WA 6847
Country
Australia
Secondary sponsor category [1] 269070 0
None
Name [1] 269070 0
Address [1] 269070 0
Country [1] 269070 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272060 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 272060 0
GPO Box X2213
Perth WA 6847
Ethics committee country [1] 272060 0
Australia
Date submitted for ethics approval [1] 272060 0
Approval date [1] 272060 0
12/12/1996
Ethics approval number [1] 272060 0
EC460

Summary
Brief summary
To assess whether the combination of fenofibrate and coenzyme Q improves vascualr health in diabetes
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33316 0
Address 33316 0
Country 33316 0
Phone 33316 0
Fax 33316 0
Email 33316 0
Contact person for public queries
Name 16563 0
Professor Gerald F Watts
Address 16563 0
University of Western Australia
School of Medicine and Pharmacology
Royal Perth Hospital Unit
GPO Box X2213
Perth WA 6847
Country 16563 0
Australia
Phone 16563 0
+61802240245
Fax 16563 0
+61802240246
Email 16563 0
Gerald.Watts@uwa.edu.au
Contact person for scientific queries
Name 7491 0
Professor Gerald F Watts
Address 7491 0
University of Western Australia
School of Medicine and Pharmacology
Royal Perth Hospital Unit
GPO Box X2213
Perth WA 6847
Country 7491 0
Australia
Phone 7491 0
+61802240245
Fax 7491 0
+61802240246
Email 7491 0
Gerald.Watts@uwa.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary