Mechanisms of Prediabetic States in Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Plasma norepinephrine levels
研究概览
简要总结
The purpose of this study is to better understand how sleep apnea contributes to the development of diabetes.
详细描述
Substantial evidence indicates that obstructive sleep apnea (OSA) is associated with impaired glucose metabolism, however, metabolic mechanisms underlying this association remain unclear. This mechanistic study will determine systemic and cellular metabolic pathways that contribute to impaired glucose metabolism in obstructive sleep apnea (OSA). Understanding of how obstructive sleep apnea (OSA) affects glucose metabolism may help identify novel targets for risk prediction and/or treatment of metabolic impairments beyond continuous positive airway pressure (CPAP). Obstructive sleep apnea (OSA) patients with prediabetes will be studied under three in-laboratory conditions in a randomized cross-over design: untreated condition (obstructive sleep apnea), treated condition (continuous positive airway pressure), untreated but pharmacologically suppressed lipolysis condition (Niacin). The investigator will perform whole body and cellular assessments under each study condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight or obese
- •Prediabetic
- •Sleep apnea
排除标准
- •Severe hypertension
- •Taking medications that can confound assessments
- •Any history of known bleeding disorders
- •Any underlying disease likely to limit life span or increase risk of intervention
- •Currently pregnant, trying to get pregnant or nursing
研究组 & 干预措施
Untreated
Untreated condition (obstructive sleep apnea)
Continuous positive airway pressure (CPAP) treatment
Continuous positive airway pressure (CPAP) treatment
干预措施: Continuous positive airway pressure (Device)
Niacin
Untreated, pharmacological suppression of lipolysis by Niacin
干预措施: Niacin (Other)
结局指标
主要结局
Plasma norepinephrine levels
时间窗: Niacin, within 4 months of screening
Plasma norepinephrine will be measured in blood
Plasma norepinephrine levels
时间窗: Untreated, within 4 months of screening
Plasma norepinephrine will be measured in blood
Plasma norepinephrine levels
时间窗: CPAP, within 4 months of screening
Plasma norepinephrine will be measured in blood
次要结局
未报告次要终点
