Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease

Study Overview
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Brief Summary
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The purpose of this study is to examine the effect of mitochondria derived oxidative stress on vascular function in patients with moderate to severe Chronic Kidney Disease.

Detailed Description
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Chronic Kidney Disease (CKD) patients are at increased risk of cardiovascular disease. Endothelial dysfunction, characterized by a reduced bioavailability in nitric oxide, is an independent predictor of cardiovascular disease in CKD. Increased oxidative stress is a potential cause of endothelial dysfunction in this patient cohort. This study investigates the role that mitochondrial derived oxidative stress plays in CKD related vascular dysfunction. In a controlled, double blinded trial, Stage 3-5 CKD patients will be randomly assigned to receive a 4 week daily dose of a mitochondria targeted antioxidant (MitoQ) or a placebo.

Official Title
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Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Dietary Supplement: MitoQ
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage 3 - 5 Chronic Kidney Disease Exclusion Criteria: History of cardiovascular disease; Current pregnancy; Uncontrolled hypertension; Uncontrolled hyperlipidemia; Current hormone replacement therapy; Current use of tobacco products; Elevated liver enzymes; Current autoimmune disease; Daily use of of antioxidants >300mg

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MitoQ<br>4 week 20mg oral daily dose of MitoQ | Dietary Supplement: MitoQ<br>* Mitochondria targeted antioxidant<br>|
| Placebo Comparator: Placebo<br>4 week 20mg oral daily placebo | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular Function, assessed by laser Doppler flowmetry coupled with microdialysis | Nitric oxide mediated cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with microdialysis | Change from baseline at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conduit artery endothelial dependent dilation, assessed by duplex ultrasound | Brachial artery flow mediated dilation assessed by duplex ultrasound | Change from baseline at 4 weeks | 
| Mitochondria derived superoxide, assessed by electron paramagnetic resonance spectroscopy | Plasma mitochondria superoxide assessed by electron paramagnetic resonance spectroscopy | Change from baseline at 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endothelium, vascular, MitoQ, Mitochondria, Oxidative Stress, Chronic Renal Insufficiency, Cardiovascular Disease