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Completed

NCT Number: NCT03248219

The Sleep in Pregnancy Study

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 24 hour glycemia measurement of the Pregnant Mother

    Time frame: Every 24 hours for 3 days

    Glycemia will be measured by Continuous glucose monitoring

  2. Evaluation of Insulin resistance of the Pregnant Mother

    Time frame: 2 hours after a 75 gram glucose load

    Insulin resistance will be measured with an Oral Glucose Tolerance Test

Secondary outcomes

  1. Infant Body Composition

    Time frame: At 2 weeks of life

    Percent of Fat Mass

  2. Stress Levels

    Time frame: 15 minutes before Sleep and 15 minutes after sleep

    Cortisol Levels

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Colorado Clinical & Translational Sciences Institute

Registry information

Official study title

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

Acronym: SiP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2017
Registry last updated
Jun 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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