Clinical trial NCT02364648: Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease
Official title: Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: Endothelium, vascular
MitoQ
Mitochondria
Oxidative Stress
Chronic Renal Insufficiency
Cardiovascular Disease
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Microvascular Function, assessed by laser Doppler flowmetry coupled with microdialysis
timeFrame: Change from baseline at 4 weeks
Secondary outcomes:
measure: Conduit artery endothelial dependent dilation, assessed by duplex ultrasound
timeFrame: Change from baseline at 4 weeks
measure: Mitochondria derived superoxide, assessed by electron paramagnetic resonance spectroscopy
timeFrame: Change from baseline at 4 weeks
Other outcomes:
measure: Endothelial cell NADPH oxidase expression
timeFrame: Change from baseline at 4 weeks
measure: Arterial Stiffness, assessed by central blood pressure, augmentation index and carotid artery to femoral artery pulse wave velocity
timeFrame: Change from baseline at 4 weeks
measure: Ambulatory Blood Pressure
timeFrame: Change from baseline at 4 weeks
measure: Habitual Physical Activity, assessed by accelerometry
timeFrame: Change from baseline at 4 weeks
Locations:
city: Newark
country: United States
facility: Department of Kinesiology and Applied Physiology, University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Danielle L Kirkman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Delaware
name: David G Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
References: