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Mitochondrial Derived Reactive Oxygen Species on Cardiovascular Health in Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MitoQ
Placebo
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring MitoQ, vascular function, cardiovascular health, exercise intolerance, Mitochondria

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinically diagnosed of COPD Global Initiative for obstructive lung disease (GOLD) Stages II to IV Exclusion Criteria: Forced Expiratory Volume in 1 second/ Functional Vital Capacity (FEV1/FVC) >0.7 Heart Disease Diabetes Vasoactive medications Uncontrolled high blood pressure Fluid in lungs Sleep apnea Raynaud's Phenomenon Gangrene of the digits History of coagulation Pregnant women Children

Sites / Locations

  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MitoQ

Placebo

Arm Description

Participants will take 1 pill each day for 6 weeks

Participants will take 1 pill each day for 6 weeks

Outcomes

Primary Outcome Measures

Change in vascular function
Flow-mediated dilation will be used to measure vasodilation in the brachial artery
Change in Skeletal Muscle Oxygenation
Near-infrared spectroscopy will be used to measure leg muscle oxygenation
Change in oxidative stress
Blood draws will be taken to measure oxidative stress markers in the blood through electron paramagnetic resonance

Secondary Outcome Measures

Change in arterial stiffness
Pulse wave velocity will be used to measure arterial stiffness.
Change in microvascular function
Microvascular function will be assessed using laser dopler imaging

Full Information

First Posted
October 28, 2022
Last Updated
September 29, 2023
Sponsor
Virginia Commonwealth University
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT05605548
Brief Title
Mitochondrial Derived Reactive Oxygen Species on Cardiovascular Health in Chronic Obstructive Pulmonary Disease (COPD)
Official Title
The Influence of Mitochondrial Derived Reactive Oxygen Species on Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Cardiovascular health is a critical problem in patients with chronic obstructive pulmonary disease (COPD). Existing literature suggests oxidative stress from the mitochondria c driving some of the poor health outcomes in COPD. MitoQ is a mitochondrial-targeted antioxidant that has shown promise in improving cardiovascular outcomes in similar populations. Thus the purpose of this study is to test if MitoQ can improve cardiovascular health in COPD.
Detailed Description
In this study, a mitochondria-specific antioxidant will be compared to a placebo. Participants will be assigned randomly to receive either the antioxidant or the placebo for 6 weeks. A comprehensive assessment of cardiovascular health will be conducted before and after the administration of the supplement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
MitoQ, vascular function, cardiovascular health, exercise intolerance, Mitochondria

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MitoQ
Arm Type
Experimental
Arm Description
Participants will take 1 pill each day for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will take 1 pill each day for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
MitoQ
Intervention Description
MitoQ is a mitochondrial targeted antioxidant that can be obtained over-the-counter.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A look-alike inactive substance, a "sugar pill"
Primary Outcome Measure Information:
Title
Change in vascular function
Description
Flow-mediated dilation will be used to measure vasodilation in the brachial artery
Time Frame
Baseline and 6 weeks
Title
Change in Skeletal Muscle Oxygenation
Description
Near-infrared spectroscopy will be used to measure leg muscle oxygenation
Time Frame
Baseline and 6 weeks
Title
Change in oxidative stress
Description
Blood draws will be taken to measure oxidative stress markers in the blood through electron paramagnetic resonance
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change in arterial stiffness
Description
Pulse wave velocity will be used to measure arterial stiffness.
Time Frame
Baseline and 6 weeks
Title
Change in microvascular function
Description
Microvascular function will be assessed using laser dopler imaging
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically diagnosed of COPD Global Initiative for obstructive lung disease (GOLD) Stages II to IV Exclusion Criteria: Forced Expiratory Volume in 1 second/ Functional Vital Capacity (FEV1/FVC) >0.7 Heart Disease Diabetes Vasoactive medications Uncontrolled high blood pressure Fluid in lungs Sleep apnea Raynaud's Phenomenon Gangrene of the digits History of coagulation Pregnant women Children
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paula Rodriguez-Miguelez, PhD
Phone
804-396-4498
Email
prodriguezmig@vcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Rodriguez-Miguelez, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Rodriguez Miguelez, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mitochondrial Derived Reactive Oxygen Species on Cardiovascular Health in Chronic Obstructive Pulmonary Disease (COPD)

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