Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- University of Delaware
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Microvascular Function, assessed by laser Doppler flowmetry coupled with microdialysis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
MitoQ
4 week 20mg oral daily dose of MitoQ
Intervention: MitoQ (Dietary Supplement)
Placebo
4 week 20mg oral daily placebo
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Microvascular Function, assessed by laser Doppler flowmetry coupled with microdialysis
Time Frame: 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 Outcomes
- Conduit artery endothelial dependent dilation, assessed by duplex ultrasound(Change from baseline at 4 weeks)
- Mitochondria derived superoxide, assessed by electron paramagnetic resonance spectroscopy(Change from baseline at 4 weeks)
Investigators
David Edwards
Associate Professor
University of Delaware