The Sleep in Pregnancy Study

NCT03248219 | Completed

• 1 other identifier: 16-2568
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Sleep Disordered Breathing; Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Infant Body Composition

  At 2 weeks of life

• Stress Levels

  15 minutes before Sleep and 15 minutes after sleep

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Colorado Clinical & Translational Sciences Institute: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Obesity

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah S Farabi, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 14, 2017
• Study Start: March 15, 2017
• Primary Completion: March 15, 2018
• Study Completion: March 20, 2018
• Last Updated: June 20, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)