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临床试验/NCT04013399
NCT04013399撤回不适用

Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy

Barnes-Jewish Hospital2 个研究点 分布在 1 个国家开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Degree of Insulin Sensitivity measured by Matsuda Index by Oral glucose Tolerance Test

研究概览

简要总结

This study will evaluate the effect of treatment of obstructive sleep apnea on insulin sensitivity in pregnant women. Women in their third trimester of pregnancy will be randomized to receive treatment or no treatment for one month.

详细描述

Obstructive Sleep Apnea (OSA) worsens over pregnancy and is related to increased risk of gestational diabetes. Despite the fact that sleep disturbances are common during pregnancy, OSA remains under-diagnosed, and poorly understood particularly in pregnancies affected by obesity. At least 25 percent of pregnancies are now affected by obesity, a leading risk factor for OSA, yet the effect of treatment of OSA on patterns of metabolic function and specifically decreased insulin sensitivity in pregnant women with obesity is a neglected area with major therapeutic implications to improve maternal health. Inflammation with OSA may decrease insulin sensitivity. Continuous positive airway pressure (CPAP) is a known effective treatment for OSA and has been shown to improve insulin sensitivity outside of pregnancy. Our overall hypothesis is that, compared with standard care, CPAP will improve nighttime breathing, blood and tissue oxygenation, decrease markers of inflammation, and increase insulin sensitivity. Using a randomized controlled trial, we will determine the effect of CPAP on metabolic dysfunction induced by OSA in pregnant women with obesity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 28-32 weeks pregnant
  • Age 20-39
  • BMI 30-40 kg/m2 pre-pregnancy (or first trimester)
  • Obstructive Sleep Apnea (AHI≥15)
  • Have a singleton pregnancy

排除标准

  • Diabetes (GDM, type 1 or type 2)
  • Using beta blockers or glucocorticoids
  • Have children who are ≤2 yrs old (risk of disrupted sleep)
  • Diagnosed sleep disorders (other than sleep apnea)
  • Night work schedule
  • Diagnosed congestive heart failure
  • Diagnosed lung disease (e.g. asthma, chronic obstructive pulmonary disease)
  • Pre-gestational hypertension

结局指标

主要结局

Degree of Insulin Sensitivity measured by Matsuda Index by Oral glucose Tolerance Test

时间窗: 1 month

Change in whole body insulin sensitivity measured using Matsuda Index

Percent of Oxygen in blood by pulse oximetry

时间窗: 1 month

Change in oxygen saturation measured by pulse oximetry

次要结局

  • Percent of Oxygen in Adipose Tissue measured by oxygen tension probe(1 month)
  • Concentration of inflammatory gene expression in adipose Tissue measured by RNA and DNA sequencing(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Farabi

Assistant Professor

Barnes-Jewish Hospital

研究点 (2)

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