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.

Effect of CoenzymeQ10 supplementation on vascular endothelial dysfunction in subjects with Type 2 diabetes mellitus who are receiving optimal statin therapy.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000250639

Acronym

CQEST

Enrollment

Registered

2005-08-31

Start date

2005-03-29

Completion date

2007-04-03

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Not applicable

Interventions

12 week crossover study of Coenzyme Q10 in subjects with Type 2 diabetes who are receiving optimal dose statin therapy.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

40 Years to 79 Years

Healthy volunteers

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.

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.

Outcome results