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临床试验/NCT03248219
NCT03248219已完成不适用

Sleep Disordered Breathing Accounts for Abnormal Glycemic Profiles in Pregnant Women: The Sleep in Pregnancy (SiP) Study

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2017年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Evaluation of Insulin resistance of the Pregnant Mother

研究概览

简要总结

Sleep disordered breathing (SDB) insidiously worsens metabolic function, heightens insulin resistance (IR), and in pregnancy is thought to precipitate gestational diabetes, preterm birth, growth restriction, gestational hypertension, and preeclampsia. Despite the fact that sleep disturbances are common during pregnancy, SDB remains under-recognized, under-diagnosed, and poorly understood, particularly in pregnancies affected by obesity. Sixty percent of pregnancies are now affected by obesity, yet the relationship between SDB, patterns of glycemia, and insulin resistance (IR) in obese pregnant women is a neglected area with major therapeutic implications to improve maternal and infant health. Using a prospective design in which diet and gestational age are highly controlled, the investigators propose to measure SDB (apneas/hypopneas) in obese pregnant women using an ambulatory sleep monitoring system. In parallel, robust patterns of glycemia will be measured with a continuous glucose monitoring system (CGMS), followed by a 75g oral glucose tolerance test to measure insulin action. The investigators global hypothesis is that worse SDB in part accounts for higher 24-hour patterns of glycemia in obese normal glucose tolerant (NGT) pregnant women in their 3rd trimester. The Investigators will test the hypothesis that: 1) In obese NGT pregnant women at 32-34 weeks gestation on a controlled eucaloric diet, higher apnea hypopnea index (AHI) will be positively associated with 24-hour glycemia measured by a CGMS and that, 2) Higher AHI in obese NGT pregnant women at 32-34 weeks gestation on a eucaloric controlled diet will be associated with higher insulin resistance measured by a 75g oral glucose tolerance test (Matsuda Model). Early identification and treatment has the potential to decrease long-term maternal cardiovascular morbidity and mortality.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Pregnant women:
  • Between the ages of 20-39 yrs,
  • At 32-34 weeks gestation,
  • Who have a BMI of ≥30 to ≤40 kg/m2,
  • Who have a singleton pregnancy, and
  • Who have a normal glucose tolerance test on entrance to the study.

排除标准

  • Pregnant Women:
  • Who have a diagnosis of diabetes (GDM, type 1 or type 2),
  • Who are using beta blockers/glucocorticoids.
  • Who have other children who are ≤2 yrs old (due to risk of disrupted sleep),
  • With diagnosed sleep disorders (e.g. OSA, insomnia, restless leg syndrome),
  • Who work night or rotating shifts,
  • Who report use of sleep medications will be excluded,
  • With diagnosed pulmonary or cardiovascular disease
  • Who do not speak English.

结局指标

主要结局

Evaluation of Insulin resistance of the Pregnant Mother

时间窗: 2 hours after a 75 gram glucose load

Insulin resistance will be measured with an Oral Glucose Tolerance Test

24 hour glycemia measurement of the Pregnant Mother

时间窗: Every 24 hours for 3 days

Glycemia will be measured by Continuous glucose monitoring

次要结局

  • Infant Body Composition(At 2 weeks of life)
  • Stress Levels(15 minutes before Sleep and 15 minutes after sleep)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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