Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease: a Mechanistic Approach
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in Sirt1 concentrations
研究概览
简要总结
Researchers have found a link between chronic obstructive pulmonary disease (COPD) and heart disease; however, a link is all they have found. Cardiovascular health in COPD is controlled by different mechanisms including vascular health and systemic inflammation. The investigators have collected preliminary data to support that concentrations of Sirtuin 1 (Sirt1), a protein that plays a key role in cardioprotection, may be involved in cardiovascular health in patients with COPD. Resveratrol, an over the counter natural polyphenol found in a variety of food, is a direct activator of Sirt1 and has been used to improve cardiovascular health in different cohorts. The current project is an attempt to expand previous findings and explore the effects of the sub-chronic use of resveratrol in sustaining the improvements in cardiovascular health in COPD.
详细描述
The present study is designed as a double-blind, randomized, cross-over, placebo-controlled protocol. Patients with COPD will receive either resveratrol (500 mg) or placebo for 12 weeks. A comprehensive evaluation of cardiovascular health will be performed. Results will provide novel insights into the mechanistic role that Sirt1 mediates in COPD related vascular dysfunction and systemic inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with a clinical diagnosis of COPD known for at least one year will be allowed to participate
- •Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages II to IV
- •Breathing test ratio (FEV1/FVC) <0.7
- •Amount of exhaled air (FEV1) <80% predicted after bronchodilator
- •Total Lung Capacity (TLC)>80%
- •Matched healthy volunteers without COPD.
排除标准
- •FEV1/FVC>0.7
- •Clinical diagnosis of heart disease, hypertension or diabetes
- •Use of vasoactive medications (nitrates, Beta blockers)
- •Uncontrolled high blood pressure
- •Pulmonary hypertension
- •Fluid in the lungs
- •Sleep apnea
- •Thyroid problems
- •Raynaud's phenomenon
- •Gastrointestinal bleeding
- •History of coagulopathies
- •History of low platelets
- •Gangrene of the digits
- •Phenylketonuria
- •Pregnant or women attempting to become pregnant
- •In lactation
- •Individuals who may not be able to read or understand the resveratrol label
研究组 & 干预措施
Resveratrol
500 mg of time released micronized trans-Resveratrol
干预措施: Resveratrol (Drug)
Placebo
Placebo will be used in the form of an empty white colored soft vegetarian capsule as resveratrol is presented
干预措施: Placebo (Other)
结局指标
主要结局
Change in Sirt1 concentrations
时间窗: Baseline to 12 weeks
Circulating concentrations of Sirt1 before and 12 weeks after both resveratrol and placebo
Change in Systemic Inflammation
时间窗: Baseline to 12 weeks
Systemic inflammation will be evaluated through the assessment of interleukin concentrations using enzyme-linked immunosorbent assay before and 12 weeks after both resveratrol and placebo.
Change in vascular health
时间窗: Baseline to 12 weeks
Assessment of vascular health through the evaluation of peripheral vascular using the flow-mediated dilation technique before and 12 weeks after both resveratrol and placebo.
次要结局
- Change in Nitric Oxide metabolism(Baseline to 12 weeks)
- Change in Inflammatory activation(Baseline to 12 weeks)