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Trial registered on ANZCTR


Trial ID
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
Gender
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
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] 441 0
Commercial sector/Industry
Name [1] 441 0
Pfizer CVL grant
Address [1] 441 0
PO Box 57, West Ryde, NSW 2114, Australia
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
Royal Perth Hospital Ethics Committee
Royal Perth Hospital,
197 Wellington Street
Perth
WA 6000
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
Not applicable
Trial website
Trial related presentations / publications
Hamilton, SJ, Chew, GT, Watts, GF: Coenzyme Q10 supplementation improves endothelial dysfunction in statin-treated Type 2 diabetic patients. Diabetes Care 2009; 32: 810-812.

Poster Presentation: Australian Atherosclerosis Society: Coenzyme Q10 supplementation improves endothelial dysfunction in statin-treated Type 2 diabetic patients. October 2008
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
gerard.chew@uwa.edu.au
Contact person for public queries
Name 9389 0
Dr 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
sandy.hamilton@uwa.edu.au
Contact person for scientific queries
Name 317 0
Dr 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
gtjchew@cyllene.uwa.edu.au