Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MitoQ | Experimental | 4 week 20mg oral daily dose of MitoQ |
|
| Placebo | Placebo Comparator | 4 week 20mg oral daily placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MitoQ | Dietary Supplement | Mitochondria targeted antioxidant |
| |
| Placebo |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial cell NADPH oxidase expression | NADPH oxidase expression in human endothelial cll expression | Change from baseline at 4 weeks |
| Arterial Stiffness, assessed by central blood pressure, augmentation index and carotid artery to femoral artery pulse wave velocity |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle L Kirkman, PhD | Contact | 302 831 4659 | dkirkman@udel.edu | |
| David G Edwards, PhD | Contact | dge@udel.edu |
| Name | Affiliation | Role |
|---|---|---|
| Danielle L Kirkman, PhD | University of Delaware | Principal Investigator |
| David G Edwards, PhD | University of Delaware | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Kinesiology and Applied Physiology, University of Delaware | Recruiting | Newark | Delaware | 19713 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C429014 | mitoquinone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dietary Supplement |
Placebo |
|
Plasma mitochondria superoxide assessed by electron paramagnetic resonance spectroscopy |
| Change from baseline at 4 weeks |
Central blood pressure, augmentation index and carotid artery to femoral artery pulse wave velocity |
| Change from baseline at 4 weeks |
| Ambulatory Blood Pressure | 2h hour continuous ambulatory blood pressure monitoring | Change from baseline at 4 weeks |
| Habitual Physical Activity, assessed by accelerometry | Daily habitual physical activity assessed by accelerometry | Change from baseline at 4 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |