Pilot study evaluating the efficacy of MitoQ in adults with type II diabetes and coronary vascular disease.

A pilot study into the effects of MitoQ on endothelial function in participants with type II diabetes and coronary vascular disease.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000293369

Acronym

MitoQ Trial

Enrollment

Registered

2017-02-24

Start date

2017-03-01

Completion date

Unknown

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

45 Years to 70 Years

Healthy volunteers

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.

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.

Outcome results