Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 45
- 主要终点
- Mean glucose level
研究概览
简要总结
Sleep disordered breathing is associated with impaired glucose tolerance and incident diabetes. Nocturnal hypoxemia is a potential stimulus of glucose intolerance. It is especially severe and highly prevalent in high altitude residents. Intervening on nocturnal hypoxemia may therefore improve glucose control and decrease the public health burden in high altitude populations.
The objective of this study is to examine the impact of hypoxemia on glucose homeostasis in high altitude residents. The investigators will address this objective by examining the effect of supplemental oxygen on glucose in a randomized cross-over study.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Permanent residents of Puno, Peru
排除标准
- •Recent travel to low altitude (<3000 m)
- •Oxygen use
- •Pregnancy
- •Morbid obesity (BMI > 40 kg/m2)
- •Current smoking
- •Other sleep disorders (e.g. circadian rhythm disorder or insomnia)
- •Use of open fires in the home (i.e. for cooking or heat)
- •Chronic Mountain Sickness (CMS) as defined by a daytime oxyhemoglobin saturation < 85%, Qinghai CMS >10 or excessive erythrocytosis as defined by hemoglobin >19 g/dL in women or >21 g/dL in men.
研究组 & 干预措施
Supplemental Oxygen then Compressed Air
Compressed Air then Supplemental Oxygen
结局指标
主要结局
Mean glucose level
时间窗: 14 days after start of intervention
average glucose (mg/dL) during sleep assessed via continuous glucose monitoring
次要结局
- Tumor Necrosis Factor alpha (TNF-a) level in blood (picogram/milliliter)(14 days after start of intervention)
- Inflammatory marker interleukin-6 (IL-6)(14 days after start of intervention)
- Mean fasting glucose level(14 days after start of intervention)
- Mean fasting insulin(14 days after start of intervention)
- Morning blood pressure(14 days after start of intervention)
- C-Reactive Protein (CRP) level in blood (mg/L)(14 days after start of intervention)