Non-pulmonary Contributors of Exercise Intolerance in Patients With Cystic Fibrosis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Sirtuin1 (Sirt1)
研究概览
简要总结
The purpose of this research study is to examine if the use of antioxidant supplements impacts exercise intolerance in people with CF.
详细描述
Exercise intolerance is a critical problem for people with cystic fibrosis (CF) able to predict hospitalization independent of lung function. Recent studies have suggested that certain supplements may help improving exercise intolerance.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of CF
- •Men and women (> 18 yrs. old)
- •FEV1 percent predicted > 40%
- •Patients with or without CF related diabetes
- •Resting oxygen saturation (room air) >90%
- •Traditional CF-antioxidant medications
- •Ability to perform reliable/reproducible PFTs
- •Clinically stable for 4 weeks (no exacerbations or need for antibiotic antioxidant within 4 weeks of testing or major change in medical status)
- •Pancreatic sufficient and pancreatic insufficient patients
排除标准
- •Children 17 years old and younger
- •FEV1<40% predicted
- •Resting O2 saturation <90%
- •Clinical diagnosis of heart disease
- •Clinical diagnosis of PAH
- •Febrile illness within 4 weeks of a study visit
- •Antioxidant for pulmonary exacerbation within 4 weeks of a study visit
- •Currently smoking, pregnant or nursing
- •Vasoactive medications (i.e. nitrates, beta-blockers, Viagra etc.)
- •Patients with B. Cepacia
研究组 & 干预措施
A: Cystic fibrosis
Patients with CF will be randomly assigned to resveratrol or placebo.
干预措施: Resveratrol (Drug)
A: Cystic fibrosis
Patients with CF will be randomly assigned to resveratrol or placebo.
干预措施: Placebo (Dietary Supplement)
A: Healthy Controls
Healthy controls will be randomly assigned to resveratrol or placebo
干预措施: Resveratrol (Drug)
A: Healthy Controls
Healthy controls will be randomly assigned to resveratrol or placebo
干预措施: Placebo (Dietary Supplement)
B: Cystic Fibrosis
Patients with CF will be randomly assigned to NR or placebo.
干预措施: NR (Drug)
B: Cystic Fibrosis
Patients with CF will be randomly assigned to NR or placebo.
干预措施: Placebo (Dietary Supplement)
B: Healthy Controls
Healthy controls will be randomly assigned to NR or placebo
干预措施: NR (Drug)
B: Healthy Controls
Healthy controls will be randomly assigned to NR or placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in Sirtuin1 (Sirt1)
时间窗: Change from baseline to up to 20 weeks
Sirt1 will be assessed via a standard assay from samples taken from the participant's vein
次要结局
未报告次要终点