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The purposes of this project are 1) to compare the impact of maternal obesity versus excessive gestational weight gain on obstructive sleep apnea (OSA) in obese and non-obese women; 2) to investigate the mechanism(s) by which obesity and OSA increase cardiovascular risk during pregnancy; and 3) to identify biomarker(s) for obesity-related OSA in pregnant women.
Aim 1: To test the hypothesis that maternal obesity increases OSA risk but to a greater extent in obese women with excessive gestational weight gain vs. obese women with normal weight gain vs. non-obese women with excessive weight gain. Study team will enroll early pregnant (≤12 weeks of gestation) obese (pre-pregnancy body mass index ≥30 kg/m2) and non-obese (body mass index 18.5-24.9 kg/m2) women and follow participants throughout gestation. In-home sleep testing will be carried out during all phases of pregnancy: early pregnancy (4-12 weeks gestation), late pregnancy (30-34 weeks of gestation) and postpartum (6-10 weeks after delivery). Investigator will compare AHI (primary endpoint), the development or worsening of OSA, and pregnancy outcomes in obese and non-obese women with and without weight gain above the Institute of Medicine (IOM) recommended levels. Various body composition areas, (e.g., neck, waist, or hips) that may be associated with risk for sleep apnea will also be measured.
Aim 2: To test the hypothesis that obesity is associated with sympathetic activation, while OSA magnifies this abnormality during pregnancy. Study team will use the state-of-the-art technique of microneurography to measure resting sympathetic activity (primary endpoint) and sympathetic neural responses to physiological stimulations (e.g., mental stress, exercise and upright posture) during early (<12 weeks) and late (30-34 weeks) pregnancy, and postpartum (6-10 weeks post) in obese women with and without OSA and non-obese women without OSA.
Aim 3: To test the hypothesis that corin content is greater in obese than nonobese women during pregnancy, and it is the greatest in obese pregnant women with OSA. Venous blood samples will be taken in women enrolled in Aim 2 study for measurements of serum corin content (primary endpoint) and pregnancy-specific angiogenic factors such as soluble fms-like tyrosine kinase 1, placental growth factor, and soluble endoglin. The relationships between maternal corin content, pregnancy-specific angiogenic factors, sympathetic activity, and BP will be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| obese women with normal gestational weight gain | obese women (body mass index ≥30 kg/m2) with weight gain 5-9 kg | ||
| obese women excessive gestational weight gain | obese women (body mass index ≥30 kg/m2) with weight gain >9 kg | ||
| non-obese women with normal gestational weight gain | non-obese women (body mass index 18.5-24.9 kg/m2) with weight gain 11.5-16 kg | ||
| non-obese women with excessive weight gain | non-obese women (body mass index 18.5-24.9 kg/m2) with weight gain >16 kg | ||
| obese women with OSA | obese women (body mass index ≥30 kg/m2) with Obstructive Sleep Apnea (OSA) (Apnea and Hypopnea Index (AHI) ≥5 events/hr | ||
| obese women without OSA | obese women (body mass index ≥30 kg/m2) without Obstructive Sleep Apnea (OSA) (AHI <5 events/ hr) | ||
| non-obese women without OSA |
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| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index (AHI) | The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea as measured by the Watch Pat device. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value ≥5 indicates more severe sleep apnea | Early pregnancy (4-12 weeks gestation) |
| Apnea Hypopnea Index (AHI) | The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea as measured by the Watch Pat device. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value ≥5 indicates more severe sleep apnea | Late pregnancy (30-34 weeks of gestation) |
| Apnea Hypopnea Index (AHI) | The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea as measured by the Watch Pat device. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value ≥5 indicates more severe sleep apnea | Post partum (6-10 weeks after delivery) |
| Resting sympathetic activity | Resting sympathetic activity is measured by microneurography, as expressed as the number of bursts per minute and as the number of bursts per 100 heart beats, to correct for differences in heart rate. | Early pregnancy (< 12 weeks gestation) |
| Resting sympathetic activity |
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Inclusion Criteria:
Exclusion Criteria:
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Study includes all women
Obese and non-obese pregnant women with and without excessive gestational weight gain; Obese and non-obese pregnant women with and without OSA
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| Name | Affiliation | Role |
|---|---|---|
| Qi Fu, MD, PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Exercise and Environment Medicine (IEEM) at Texas Health Presbyterian Hospital | Dallas | Texas | 75231 | United States | ||
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D000079262 | Pregnancy in Obesity |
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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non-obese women without OSA (AHI <5 events/ hr)
Resting sympathetic activity is measured by microneurography, as expressed as the number of bursts per minute and as the number of bursts per 100 heart beats, to correct for differences in heart rate.
| Late pregnancy (30-34 weeks of gestation) |
| Resting sympathetic activity | Resting sympathetic activity is measured by microneurography, as expressed as the number of bursts per minute and as the number of bursts per 100 heart beats, to correct for differences in heart rate. | Post partum (6-10 weeks after delivery) |
| Serum corin content measurement | Serum corin content will be measured by venous blood samples | Early pregnancy (< 12 weeks gestation) |
| Serum corin content measurement | Serum corin content will be measured by venous blood samples | Late pregnancy (30-34 weeks of gestation) |
| Serum corin content measurement | Serum corin content will be measured by venous blood samples | Post partum (6-10 weeks after delivery) |
| University of Texas Southwestern Medical Center Dallas |
| Dallas |
| Texas |
| 75390 |
| United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |