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临床试验/NCT05605548
NCT05605548终止早期 1 期

The Influence of Mitochondrial Derived Reactive Oxygen Species on Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2023年2月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
终止
入组人数
4
试验地点
1
主要终点
Change in Skeletal Muscle Oxygenation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinically diagnosed of COPD
  • Global Initiative for obstructive lung disease (GOLD) Stages II to IV

排除标准

  • Forced Expiratory Volume in 1 second/ Functional Vital Capacity (FEV1/FVC) >0.7
  • Heart Disease
  • Vasoactive medications
  • Uncontrolled high blood pressure
  • Fluid in lungs
  • Sleep apnea
  • Raynaud's Phenomenon
  • Gangrene of the digits
  • History of coagulation
  • Pregnant women

研究组 & 干预措施

MitoQ

Experimental

Participants will take 1 pill each day for 6 weeks

干预措施: MitoQ (Drug)

Placebo

Placebo Comparator

Participants will take 1 pill each day for 6 weeks

干预措施: Placebo (Other)

结局指标

主要结局

Change in Skeletal Muscle Oxygenation

时间窗: Baseline and 6 weeks

Near-infrared spectroscopy will be used to measure leg muscle oxygenation

Change in vascular function

时间窗: Baseline and 6 weeks

Flow-mediated dilation will be used to measure vasodilation in the brachial artery

Change in oxidative stress

时间窗: Baseline and 6 weeks

Blood draws will be taken to measure oxidative stress markers in the blood through electron paramagnetic resonance

次要结局

  • Change in arterial stiffness(Baseline and 6 weeks)
  • Change in microvascular function(Baseline and 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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