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Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02364648
Recruitment Status : Recruiting
First Posted : February 18, 2015
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
David Edwards, University of Delaware

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Dietary Supplement: MitoQ Dietary Supplement: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: MitoQ
4 week 20mg oral daily dose of MitoQ
Dietary Supplement: MitoQ
Mitochondria targeted antioxidant

Placebo Comparator: Placebo
4 week 20mg oral daily placebo
Dietary Supplement: Placebo
Placebo




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Conduit artery endothelial dependent dilation, assessed by duplex ultrasound [ Time Frame: Change from baseline at 4 weeks ]
    Brachial artery flow mediated dilation assessed by duplex ultrasound

  2. Mitochondria derived superoxide, assessed by electron paramagnetic resonance spectroscopy [ Time Frame: Change from baseline at 4 weeks ]
    Plasma mitochondria superoxide assessed by electron paramagnetic resonance spectroscopy


Other Outcome Measures:
  1. Endothelial cell NADPH oxidase expression [ Time Frame: Change from baseline at 4 weeks ]
    NADPH oxidase expression in human endothelial cll expression

  2. Arterial Stiffness, assessed by central blood pressure, augmentation index and carotid artery to femoral artery pulse wave velocity [ Time Frame: Change from baseline at 4 weeks ]
    Central blood pressure, augmentation index and carotid artery to femoral artery pulse wave velocity

  3. Ambulatory Blood Pressure [ Time Frame: Change from baseline at 4 weeks ]
    2h hour continuous ambulatory blood pressure monitoring

  4. Habitual Physical Activity, assessed by accelerometry [ Time Frame: Change from baseline at 4 weeks ]
    Daily habitual physical activity assessed by accelerometry



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364648


Contacts
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Contact: Danielle L Kirkman, PhD 302 831 4659 dkirkman@udel.edu
Contact: David G Edwards, PhD dge@udel.edu

Locations
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United States, Delaware
Department of Kinesiology and Applied Physiology, University of Delaware Recruiting
Newark, Delaware, United States, 19713
Contact: David Edwards, PhD       dge@udel.edu   
Contact: Danielle Kirkman, PhD       dkirkman@udel.edu   
Principal Investigator: Danielle Kirkman, PhD         
Principal Investigator: David Edwards, PhD         
Sponsors and Collaborators
University of Delaware
Investigators
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Principal Investigator: Danielle L Kirkman, PhD University of Delaware
Principal Investigator: David G Edwards, PhD University of Delaware
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Responsible Party: David Edwards, Associate Professor, University of Delaware
ClinicalTrials.gov Identifier: NCT02364648    
Other Study ID Numbers: 680076-2
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Edwards, University of Delaware:
Endothelium, vascular
MitoQ
Mitochondria
Oxidative Stress
Chronic Renal Insufficiency
Cardiovascular Disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency