<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03248219</url>
  </required_header>
  <id_info>
    <org_study_id>16-2568</org_study_id>
    <nct_id>NCT03248219</nct_id>
  </id_info>
  <brief_title>The Sleep in Pregnancy Study</brief_title>
  <acronym>SiP</acronym>
  <official_title>Sleep Disordered Breathing Accounts for Abnormal Glycemic Profiles in Pregnant Women: The Sleep in Pregnancy (SiP) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Center for Womens Health Research at University of Colorado Anschutz Medical Campus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>College of Nursing at University of Colorado Anschutz Medical Campus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Colorado Clinical &amp; Translational Sciences Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sleep disordered breathing (SDB) insidiously worsens metabolic function, heightens insulin&#xD;
      resistance (IR), and in pregnancy is thought to precipitate gestational diabetes, preterm&#xD;
      birth, growth restriction, gestational hypertension, and preeclampsia. Despite the fact that&#xD;
      sleep disturbances are common during pregnancy, SDB remains under-recognized,&#xD;
      under-diagnosed, and poorly understood, particularly in pregnancies affected by obesity.&#xD;
      Sixty percent of pregnancies are now affected by obesity, yet the relationship between SDB,&#xD;
      patterns of glycemia, and insulin resistance (IR) in obese pregnant women is a neglected area&#xD;
      with major therapeutic implications to improve maternal and infant health. Using a&#xD;
      prospective design in which diet and gestational age are highly controlled, the investigators&#xD;
      propose to measure SDB (apneas/hypopneas) in obese pregnant women using an ambulatory sleep&#xD;
      monitoring system. In parallel, robust patterns of glycemia will be measured with a&#xD;
      continuous glucose monitoring system (CGMS), followed by a 75g oral glucose tolerance test to&#xD;
      measure insulin action. The investigators global hypothesis is that worse SDB in part&#xD;
      accounts for higher 24-hour patterns of glycemia in obese normal glucose tolerant (NGT)&#xD;
      pregnant women in their 3rd trimester. The Investigators will test the hypothesis that: 1) In&#xD;
      obese NGT pregnant women at 32-34 weeks gestation on a controlled eucaloric diet, higher&#xD;
      apnea hypopnea index (AHI) will be positively associated with 24-hour glycemia measured by a&#xD;
      CGMS and that, 2) Higher AHI in obese NGT pregnant women at 32-34 weeks gestation on a&#xD;
      eucaloric controlled diet will be associated with higher insulin resistance measured by a 75g&#xD;
      oral glucose tolerance test (Matsuda Model). Early identification and treatment has the&#xD;
      potential to decrease long-term maternal cardiovascular morbidity and mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Actual">March 20, 2018</completion_date>
  <primary_completion_date type="Actual">March 15, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>24 hour glycemia measurement of the Pregnant Mother</measure>
    <time_frame>Every 24 hours for 3 days</time_frame>
    <description>Glycemia will be measured by Continuous glucose monitoring</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of Insulin resistance of the Pregnant Mother</measure>
    <time_frame>2 hours after a 75 gram glucose load</time_frame>
    <description>Insulin resistance will be measured with an Oral Glucose Tolerance Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infant Body Composition</measure>
    <time_frame>At 2 weeks of life</time_frame>
    <description>Percent of Fat Mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress Levels</measure>
    <time_frame>15 minutes before Sleep and 15 minutes after sleep</time_frame>
    <description>Cortisol Levels</description>
  </secondary_outcome>
  <enrollment type="Actual">19</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Sleep Disordered Breathing</condition>
  <condition>Obesity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women who are 32-34 weeks pregnant who live in the Denver Metro Area&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women:&#xD;
&#xD;
               1. Between the ages of 20-39 yrs,&#xD;
&#xD;
               2. At 32-34 weeks gestation,&#xD;
&#xD;
               3. Who have a BMI of ≥30 to ≤40 kg/m2,&#xD;
&#xD;
               4. Who have a singleton pregnancy, and&#xD;
&#xD;
               5. Who have a normal glucose tolerance test on entrance to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant Women:&#xD;
&#xD;
               1. Who have a diagnosis of diabetes (GDM, type 1 or type 2),&#xD;
&#xD;
               2. Who are using beta blockers/glucocorticoids.&#xD;
&#xD;
               3. Who have other children who are ≤2 yrs old (due to risk of disrupted sleep),&#xD;
&#xD;
               4. With diagnosed sleep disorders (e.g. OSA, insomnia, restless leg syndrome),&#xD;
&#xD;
               5. Who work night or rotating shifts,&#xD;
&#xD;
               6. Who report use of sleep medications will be excluded,&#xD;
&#xD;
               7. With diagnosed pulmonary or cardiovascular disease&#xD;
&#xD;
               8. Who do not speak English.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah S Farabi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado - Anschutz Medical Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>June 18, 2018</last_update_submitted>
  <last_update_submitted_qc>June 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03248219
org study id: 16-2568
nct id: NCT03248219
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Only
time perspective: Prospective
measure: 24 hour glycemia measurement of the Pregnant Mother
time frame: Every 24 hours for 3 days
description: Glycemia will be measured by Continuous glucose monitoring
measure: Evaluation of Insulin resistance of the Pregnant Mother
time frame: 2 hours after a 75 gram glucose load
description: Insulin resistance will be measured with an Oral Glucose Tolerance Test
measure: Infant Body Composition
time frame: At 2 weeks of life
description: Percent of Fat Mass
measure: Stress Levels
time frame: 15 minutes before Sleep and 15 minutes after sleep
description: Cortisol Levels
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sarah S Farabi, PhD
role: Principal Investigator
affiliation: University of Colorado - Anschutz Medical Campus
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Aspiration
mesh term: Sleep Apnea Syndromes
sharing ipd: No