Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000250639
Ethics application status
Approved
Date submitted
16/08/2005
Date registered
31/08/2005
Date last updated
4/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to investigate the effect of taking CoenzymeQ10 supplements on abnormal artery blood vessel function in people with Type 2 diabetes who are on best-dose treatment with statin medication.
Scientific title
Effect of CoenzymeQ10 supplementation on vascular endothelial dysfunction in subjects with Type 2 diabetes mellitus who are receiving optimal statin therapy.
Secondary ID [1] 287789 0
Nil
Universal Trial Number (UTN)
Trial acronym
CQEST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endothelial dysfunction in Type 2 Diabetes 337 0
Condition category
Condition code
Metabolic and Endocrine 389 389 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 week crossover study of Coenzyme Q10 in subjects with Type 2 diabetes who are receiving optimal dose statin therapy.
Intervention code [1] 200 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 446 0
Brachial artery ultrasound: change in %FMD (flow-mediated dilatation, endothelium-mediated).
Timepoint [1] 446 0
Weeks 0, 12, 16 and 28
Secondary outcome [1] 977 0
1.Forearm plethysmography: changes in forearm blood flow
Timepoint [1] 977 0
Weeks 0, 12, 16 and 28
Secondary outcome [2] 978 0
2.Non-invasive measures of arterial stiffness (applanation tonometry and arterial pulse wave analysis): Small and large artery compliance, Augmentation index, and Pulse wave velocity.
Timepoint [2] 978 0
Weeks 0, 12, 16 and 28
Secondary outcome [3] 979 0
3. Biological Markers.
Timepoint [3] 979 0
Weeks 0, 12, 16 and 28

Eligibility
Key inclusion criteria
Subjects with type 2 diabetes; treatment with HMG-CoA reductase inhibitor (statin) at a stable dose for 6 weeks; fasting LDL-cholesterol<2.5mmol/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
At screening: daytime insulin treatment (nocte insulin permitted); uncontrolled hyperglycaemia (HbA1c level>8.5%); uncontrolled hypertension (resting BP>150/90mmHg); total fasting cholesterol 6.0mmol/L or triglycerides 3.0mmol/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); recent cardiovascular event (within previous 6 months); atrial fibrillation or other significant dysrhythmia; significantly abnormal renal, liver or thyroid function; 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)
Blinded treatment generated to study numbers 001 - 025. Treatment allocated sequentially (starting 001) as per blinded treatment order on subject randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/03/2005
Actual
29/03/2005
Date of last participant enrolment
Anticipated
Actual
3/04/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 441 0
Commercial sector/Industry
Name [1] 441 0
Pfizer CVL grant
Country [1] 441 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pfizer CVL grant
Address
Unknown
Country
Australia
Secondary sponsor category [1] 359 0
Commercial sector/Industry
Name [1] 359 0
Coenzyme Q10 and placebo capsules supplied by Blackmores Ltd
Address [1] 359 0
23 Roseberry Street, Balgowlah, NSW 2093, Australia
Country [1] 359 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1414 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 1414 0
Ethics committee country [1] 1414 0
Australia
Date submitted for ethics approval [1] 1414 0
Approval date [1] 1414 0
20/09/2002
Ethics approval number [1] 1414 0

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

Contacts
Principal investigator
Name 36241 0
Dr Gerard Chew
Address 36241 0
School of Medicine and Pharmacology
Royal Perth Hospital
197 Wellington Street
Perth
WA 6000
Country 36241 0
Australia
Phone 36241 0
61 8 9224 0245
Fax 36241 0
Email 36241 0
[email protected]
Contact person for public queries
Name 9389 0
Sandra Hamilton
Address 9389 0
Western Australian Centre for Rural Health
167 Fitzgerald Street
Geraldton
WA6530
Country 9389 0
Australia
Phone 9389 0
61 8 99560231
Fax 9389 0
61 8 99346034
Email 9389 0
[email protected]
Contact person for scientific queries
Name 317 0
Dr Gerard Chew
Address 317 0
School of Medicine and Pharmacology
Royal Perth Hospital
Rear 50 Murray Street
Perth WA 6001
Country 317 0
Australia
Phone 317 0
+61 8 92240312
Fax 317 0
+61 8 92240243
Email 317 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.