The Sleep in Pregnancy Study

Obesity Clinical Trial

— SiP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248219
• Other study ID #: 16-2568
• Status: Completed
• Start date: March 15, 2017
• Est. completion date: March 20, 2018

Study information

• Verified date: June 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 20, 2018
• Est. primary completion date: March 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Pregnancy Related
• Respiratory Aspiration
• Sleep Disordered Breathing

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Center for Womens Health Research at University of Colorado Anschutz Medical Campus, College of Nursing at University of Colorado Anschutz Medical Campus, Colorado Clinical & Translational Sciences Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour glycemia measurement of the Pregnant Mother	Glycemia will be measured by Continuous glucose monitoring	Every 24 hours for 3 days
Primary	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	Infant Body Composition	Percent of Fat Mass	At 2 weeks of life
Secondary	Stress Levels	Cortisol Levels	15 minutes before Sleep and 15 minutes after sleep