跳至主要内容
临床试验/NCT04234217
NCT04234217进行中(未招募)不适用

Mechanisms of Prediabetic States in Sleep Apnea

University of Chicago2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年11月26日最近更新:
适应症
干预措施

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

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

No Intervention

Untreated condition (obstructive sleep apnea)

Continuous positive airway pressure (CPAP) treatment

Active Comparator

Continuous positive airway pressure (CPAP) treatment

干预措施: Continuous positive airway pressure (Device)

Niacin

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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