Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000297628
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
5/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of CoEnzymeQ10 on vascular function in type 2 diabetes mellitus: a pilot study.
Scientific title
The effect of CoEnzymeQ10 on vascular function in type 2 diabetes mellitus: a pilot study.
Universal Trial Number (UTN)
Trial acronym
Pilot CoQ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes and impaired vascular endothelial function (measured by flow-mediated vasodilatation (FMD) of brachial artery using ultrasound). 385 0
Condition category
Condition code
Metabolic and Endocrine 456 456 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An open-label non-randomised sequential pilot trial. Whilst continuing on their usual medications (which may include lipid-lowering and/or antihypertensive therapies), eligible subjects are supplemented with oral CoEnzymeQ10 (CoQ) 200mg daily for four weeks (supplementation period 1). Following this, CoQ supplementation is ceased for four weeks (washout period - no placebo given), before being restarted at the same dose for a further four weeks (supplementation period 2).
Intervention code [1] 287 0
Treatment: Other
Comparator / control treatment
There is no separate comparison group (analysis by paired comparison of changes in primary outcome on and off CoQ supplementation) and sequential treatment order is identical for all subjects.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 517 0
Change in flow-mediated vasodilation (FMD) of brachial artery, measured by ultrasound.
Timepoint [1] 517 0
Measurements will be performed at baseline (week 0), at end of supplementation period 1 (week 4), at end of washout (week 8) and at end of supplementation 2 (week 12).
Secondary outcome [1] 1110 0
Endothelium-independent nitrate-mediated brachial artery dilatation (NMD), measured by ultrasound; large (C1) and small (C2) artery compliance, measured by non-invasive radial pulse wave analysis (PulseWave CR-2000 system, HDI).
Timepoint [1] 1110 0
Measured at weeks 0, 4, 8 and 12.

Eligibility
Key inclusion criteria
Adult subjects with type 2 diabetes with screening FMD of <5%, who were able to provide informed consent.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Uncontrolled glycaemia (HbA1c 9.0% or greater); daytime insulin use; advanced renal impairment (serum creatinine>300umol/L); clinical cardiac failure; recent vascular event (acute myocardial infarction or stroke within preceding three months).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Sequential
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/11/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 505 0
University
Name [1] 505 0
School of Medicine and Pharmacology, University of Western Australia (Royal Perth Hospital Unit) internal departmental funds
Country [1] 505 0
Australia
Funding source category [2] 506 0
Commercial sector/Industry
Name [2] 506 0
Blackmores
Country [2] 506 0
Australia
Primary sponsor type
Individual
Name
Professor Gerald F Watts
Address
Country
Secondary sponsor category [1] 414 0
None
Name [1] 414 0
N/A
Address [1] 414 0
Country [1] 414 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1485 0
Royal Perth Hospital
Ethics committee address [1] 1485 0
Ethics committee country [1] 1485 0
Australia
Date submitted for ethics approval [1] 1485 0
Approval date [1] 1485 0
Ethics approval number [1] 1485 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35269 0
Address 35269 0
Country 35269 0
Phone 35269 0
Fax 35269 0
Email 35269 0
Contact person for public queries
Name 9476 0
Ms Mary-Ann Powell
Address 9476 0
GPO Box X2213, PERTH WA 6847
Country 9476 0
Australia
Phone 9476 0
+61 8 92240244
Fax 9476 0
+61 8 92240243
Email 9476 0
[email protected]
Contact person for scientific queries
Name 404 0
Professor Gerald F Watts
Address 404 0
GPO Box X2213 PERTH WA 6847
Country 404 0
Australia
Phone 404 0
+61 8 92240248
Fax 404 0
+61 8 92240246
Email 404 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.