Clinical trial NCT03248219: The Sleep in Pregnancy Study
Official title: Sleep Disordered Breathing Accounts for Abnormal Glycemic Profiles in Pregnant Women: The Sleep in Pregnancy (SiP) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Sleep Disordered Breathing
Obesity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado Clinical & Translational Sciences Institute
First posted: 2017-08-14
Enrollment: 19
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who are 32-34 weeks pregnant who live in the Denver Metro Area

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Pregnant women:

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

Exclusion Criteria:

* Pregnant Women:

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

Primary outcomes:
measure: 24 hour glycemia measurement of the Pregnant Mother
timeFrame: Every 24 hours for 3 days
measure: Evaluation of Insulin resistance of the Pregnant Mother
timeFrame: 2 hours after a 75 gram glucose load
Secondary outcomes:
measure: Infant Body Composition
timeFrame: At 2 weeks of life
measure: Stress Levels
timeFrame: 15 minutes before Sleep and 15 minutes after sleep
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sarah S Farabi, PhD
role: PRINCIPAL_INVESTIGATOR
References: