Clinical trial NCT04013399: Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy
Official title: Obstructive Sleep Apnea Treatment and Insulin Sensitivity in Pregnancy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Pregnancy Related
Insulin Sensitivity
Lead sponsor: Barnes-Jewish Hospital
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2019-07-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will evaluate the effect of treatment of obstructive sleep apnea on insulin sensitivity in pregnant women. Women in their third trimester of pregnancy will be randomized to receive treatment or no treatment for one month.

Detailed description: Obstructive Sleep Apnea (OSA) worsens over pregnancy and is related to increased risk of gestational diabetes. Despite the fact that sleep disturbances are common during pregnancy, OSA remains under-diagnosed, and poorly understood particularly in pregnancies affected by obesity. At least 25 percent of pregnancies are now affected by obesity, a leading risk factor for OSA, yet the effect of treatment of OSA on patterns of metabolic function and specifically decreased insulin sensitivity in pregnant women with obesity is a neglected area with major therapeutic implications to improve maternal health. Inflammation with OSA may decrease insulin sensitivity. Continuous positive airway pressure (CPAP) is a known effective treatment for OSA and has been shown to improve insulin sensitivity outside of pregnancy. Our overall hypothesis is that, compared with standard care, CPAP will improve nighttime breathing, blood and tissue oxygenation, decrease markers of inflammation, and increase insulin sensitivity. Using a randomized controlled trial, we will determine the effect of CPAP on metabolic dysfunction induced by OSA in pregnant women with obesity.

Eligibility criteria: Inclusion Criteria:

* 28-32 weeks pregnant
* Age 20-39
* BMI 30-40 kg/m2 pre-pregnancy (or first trimester)
* Obstructive Sleep Apnea (AHI≥15)
* Have a singleton pregnancy

Exclusion Criteria:

* Diabetes (GDM, type 1 or type 2)
* Using beta blockers or glucocorticoids
* Have children who are ≤2 yrs old (risk of disrupted sleep)
* Diagnosed sleep disorders (other than sleep apnea)
* Night work schedule
* Diagnosed congestive heart failure
* Diagnosed lung disease (e.g. asthma, chronic obstructive pulmonary disease)
* Pre-gestational hypertension

Primary outcomes:
measure: Degree of Insulin Sensitivity measured by Matsuda Index by Oral glucose Tolerance Test
timeFrame: 1 month
measure: Percent of Oxygen in blood by pulse oximetry
timeFrame: 1 month
Secondary outcomes:
measure: Percent of Oxygen in Adipose Tissue measured by oxygen tension probe
timeFrame: 1 month
measure: Concentration of inflammatory gene expression in adipose Tissue measured by RNA and DNA sequencing
timeFrame: 1 month
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
References: