The Sleep in Pregnancy Study (SiP)

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

Study Overview

• Status: Completed
• Conditions: Obesity; Pregnancy Related; Sleep Disordered Breathing

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who are 32-34 weeks pregnant who live in the Denver Metro Area

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour glycemia measurement of the Pregnant Mother	Glycemia will be measured by Continuous glucose monitoring	Every 24 hours for 3 days
Evaluation of Insulin resistance of the Pregnant Mother	Insulin resistance will be measured with an Oral Glucose Tolerance Test	2 hours after a 75 gram glucose load

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant Body Composition	Percent of Fat Mass	At 2 weeks of life
Stress Levels	Cortisol Levels	15 minutes before Sleep and 15 minutes after sleep

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Colorado Clinical & Translational Sciences Institute; Center for Womens Health Research at University of Colorado Anschutz Medical Campus; College of Nursing at University of Colorado Anschutz Medical Campus
• Investigators: Principal Investigator: Sarah S Farabi, PhD, University of Colorado - Anschutz Medical Campus

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): March 15, 2018
• Study Completion (Actual): March 20, 2018

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Respiratory Aspiration
• Other Study ID Numbers: 16-2568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No