Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000293369
Ethics application status
Approved
Date submitted
19/02/2017
Date registered
24/02/2017
Date last updated
24/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study evaluating the efficacy of MitoQ in adults with type II diabetes and coronary vascular disease.
Scientific title
A pilot study into the effects of MitoQ on endothelial function in participants with type II diabetes and coronary vascular disease.
Secondary ID [1] 290539 0
None
Universal Trial Number (UTN)
U1111-1193-2583
Trial acronym
MitoQ Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 300967 0
Coronary vascular disease. 302162 0
Condition category
Condition code
Cardiovascular 300769 300769 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 301773 301773 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study treatment will consist of 20mg oral MitoQ (Mitoquinol Mesylate) capsules taken orally once per day (4 x 5mg capsules) or matching placebo (4 x capsules). The active ingredient is MitoQ (Mitoquinol Mesylate). The adherence to treatment will be monitored via capsule count on return at 1 month. The treatment period is for 1 month.
Intervention code [1] 297225 0
Treatment: Other
Comparator / control treatment
matching placebo capsules containing: Chromium Picolinate, Zinc Amino Acid Chelate, Zinc, Cinnamomum Cassia.
Control group
Placebo

Outcomes
Primary outcome [1] 301155 0
The outcome measure is endothelial dilatation of the brachial artery using ultrasound to measure dilatation of the artery after 5 minutes of artery occlusion via a blood pressure cuff.
Timepoint [1] 301155 0
1 month
Secondary outcome [1] 331875 0
Change in serum marker from baseline to 1 month: C-Reactive Protein,
Timepoint [1] 331875 0
1 month
Secondary outcome [2] 331954 0
Change in serum vascular cell adhesion molecule (VCAM),
Timepoint [2] 331954 0
1 month
Secondary outcome [3] 331955 0
Change in serum Intercellular adhesion molecule (ICAM),
Timepoint [3] 331955 0
1 month
Secondary outcome [4] 331956 0
Change in serum e-selectin.
Timepoint [4] 331956 0
1 month.
Secondary outcome [5] 331957 0
Change in serum interleukin-6 (IL-6).
Timepoint [5] 331957 0
1 month
Secondary outcome [6] 331958 0
Change in serum tumour necrosis factor-a (TNF a).
Timepoint [6] 331958 0
1 month.
Secondary outcome [7] 331959 0
Change in serum soluble P selectin.
Timepoint [7] 331959 0
1 month.
Secondary outcome [8] 331960 0
Change in serum growth differentiation factor 15 (GDF 15).
Timepoint [8] 331960 0
1 month
Secondary outcome [9] 331961 0
Change in serum HbA1c.
Timepoint [9] 331961 0
3 months.
Secondary outcome [10] 331962 0
Change in resting heart rate as assessed by automated blood pressure machine.
Timepoint [10] 331962 0
1 month
Secondary outcome [11] 331963 0
Incidence of adverse events will be recorded and reported during the study period. Known or expected side effects include gastrointestinal disturbances and sleep disturbances.
Timepoint [11] 331963 0
1 month
Secondary outcome [12] 331964 0
Treatment interruption will be assessed via a pill count conducted at the end of the treatment period (1 month visit).
Timepoint [12] 331964 0
1 month

Eligibility
Key inclusion criteria
Participants are male or female aged >45 years and <70 years with a confirmed diagnosis of type II diabetes and coronary vascular disease currently taking at least one oral anti-hyperglycaemic medication.
Minimum age
45 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with a BMI>40 kg/m2, participants currently smoking, participants currently taking insulin, participants with use of open label Coenzyme Q10 Supplementation, participants who are currently taking Warfarin participants using antioxidants, participants with uncontrolled hypertension (>160/90 mmHg), participants allergic to any of the formulation excipients or mitoquinone mesylate will be excluded and participants unable to complete all study visits will also be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
treatment allocation is concealled by the method of numbered containers which have been randomly allocated to a treatment group by an independent statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software package.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. The mean percentage change from baseline in FMD +/-standard error of the mean
2. Mean percentage change from baseline in heart rate compared to placebo.
3. Mean percentage change from baseline in HbA1c compared to placebo.
4. Mean percentage change e from baseline in biomarkers compared to placebo.
5. Number of subject withdrawals due to adverse effects compared to placebo.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 8678 0
New Zealand
State/province [1] 8678 0
Auckland

Funding & Sponsors
Funding source category [1] 295674 0
Government body
Name [1] 295674 0
The funding is being provided Callaghan Innovation
Country [1] 295674 0
New Zealand
Funding source category [2] 295695 0
Commercial sector/Industry
Name [2] 295695 0
Funding is being provided by Antipodean Pharmaceuticals
Country [2] 295695 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
85 Park Road, Grafton, 1023, Auckland
Country
New Zealand
Secondary sponsor category [1] 294522 0
None
Name [1] 294522 0
Address [1] 294522 0
Country [1] 294522 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296989 0
UNIVERSITY OF AUCKLAND HUMAN PARTICIPANTS ETHICS COMMITTEE (UAHPEC)
Ethics committee address [1] 296989 0
University of Auckland
Level 10, 49 Symonds Street, 1023, Auckland
Ethics committee country [1] 296989 0
New Zealand
Date submitted for ethics approval [1] 296989 0
07/11/2016
Approval date [1] 296989 0
19/12/2016
Ethics approval number [1] 296989 0
018481

Summary
Brief summary
The primary aim of this project is to investigate the feasibility of the proposed study
design. The study is designed to investigate the potential effects of MitoQ on the
endothelial vascular system. A technique that is commonly used in research will be
employed in this study. The technique is called Flow Mediated Dilatation (FMD).
The primary objective for the project will be measured using the FMD technique.
Secondary objectives include: looking at the effect on heart rate, blood sugar levels
via the HbA1c test, checking the levels of certain biomarkers of inflammation and
comparing the number of treatment interruptions in both arms of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70466 0
Dr Andrea Braakhuis
Address 70466 0
Faculty of Medical and Health Science
University of Auckland
85 Park Road
Grafton, 1023
Auckland
Country 70466 0
New Zealand
Phone 70466 0
+64 9 923 6251
Fax 70466 0
+64 9 923 6251
Email 70466 0
a.braakhuis@auckland.ac.nz
Contact person for public queries
Name 70467 0
Mrs Caroline Alsweiler
Address 70467 0
Green Lane Coordinating Centre Ltd
30 Rossmay Terrace
Mount Eden, 1024
Auckland
Country 70467 0
New Zealand
Phone 70467 0
+6493202502
Fax 70467 0
+6493203503
Email 70467 0
csor001@aucklanduni.ac.nz
Contact person for scientific queries
Name 70468 0
Dr Andrea Braakhuis
Address 70468 0
Faculty of Medical and Health Science
University of Auckland
85 Park Road
Grafton, 1023
Auckland
Country 70468 0
New Zealand
Phone 70468 0
+64 9 923 6251
Fax 70468 0
+64 9 923 6251
Email 70468 0
a.braakhuis@auckland.ac.nz

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No Supporting Document Provided



Results publications and other study-related documents

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