Trial Review

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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
Sex
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
1/02/1997
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
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
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
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
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
[email protected]
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
[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.