Chronic Kidney Disease
Conditions
Keywords
Endothelium, vascular, MitoQ, Mitochondria, Oxidative Stress, Chronic Renal Insufficiency, Cardiovascular Disease
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTMitoQ
Mitochondria targeted antioxidant
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
University of Delaware
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microvascular Function, assessed by laser Doppler flowmetry coupled with microdialysis | Change from baseline at 4 weeks | Nitric oxide mediated cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with microdialysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conduit artery endothelial dependent dilation, assessed by duplex ultrasound | Change from baseline at 4 weeks | Brachial artery flow mediated dilation assessed by duplex ultrasound |
| Mitochondria derived superoxide, assessed by electron paramagnetic resonance spectroscopy | Change from baseline at 4 weeks | Plasma mitochondria superoxide assessed by electron paramagnetic resonance spectroscopy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Endothelial cell NADPH oxidase expression | Change from baseline at 4 weeks | NADPH oxidase expression in human endothelial cll expression |
| Habitual Physical Activity, assessed by accelerometry | Change from baseline at 4 weeks | Daily habitual physical activity assessed by accelerometry |
| Arterial Stiffness, assessed by central blood pressure, augmentation index and carotid artery to femoral artery pulse wave velocity | Change from baseline at 4 weeks | Central blood pressure, augmentation index and carotid artery to femoral artery pulse wave velocity |
| Ambulatory Blood Pressure | Change from baseline at 4 weeks | 2h hour continuous ambulatory blood pressure monitoring |
Countries
United States
Contacts
Primary ContactDanielle L Kirkman, PhD
Backup ContactDavid G Edwards, PhD
Outcome results
None listed