NCT04636138进行中（未招募）不适用
Pharmacogenomic Modulators of Impaired Exercise Adaptation in Statin Users
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Peak oxygen consumption (VO2max)
研究概览
简要总结
3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) have beneficial effects (prevent stroke, heart attack) but also some bad ones (block some good effects of exercise). Individuals have genetic variations in proteins that metabolize/transport statins. The investigators hypothesize that these variations modulate the relationship between statin use and lack of benefit from exercise. The investigators will test this by having statin-users do supervised exercise for 6 weeks, measuring the cardiorespiratory fitness before/after and correlating this to genetic variations present in the participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English-speaking
- •Adults (aged 35-65 years)
- •Overweight or obese (body-mass index [BMI] 25-43)
- •Currently taking high-dose atorvastatin (40-80mg once daily) for primary prevention of cardiovascular disease and/or stroke
- •Sedentary (<30 minutes of structured exercise weekly)
- •Willing to participate in supervised exercise three times weekly
- •Willing to not make intentional changes to their diet during the study period.
排除标准
- •Tobacco smokers
- •Pregnant or breastfeeding
- •Use other medications that affect lipid metabolism (e.g. fibric acid, fish oil)
- •Markedly functional debilitated and unable to exert 4 metabolic equivalents (METs) of energy (e.g. unable to climb a flight of stairs without stopping), or who have
- •Been advised by a physician to avoid exercise due to comorbid serious cardiovascular disease
- •Uncontrolled diabetes (A1c > 8)
- •Uncontrolled thyroid disease
- •History of myocardial infarction or stroke
- •History of statin-induced myopathy.
结局指标
主要结局
Peak oxygen consumption (VO2max)
时间窗: 6 weeks
Change pre/post intervention; compared with genomic variants
次要结局
- Resting systolic blood pressure(6 weeks)
- Resting heart rate(6 weeks)
- Weight(6 weeks)
研究者
研究点 (2)
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