<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/NCT01707784</url>
  </required_header>
  <id_info>
    <org_study_id>295/12</org_study_id>
    <nct_id>NCT01707784</nct_id>
  </id_info>
  <brief_title>Effects of Stress on Glucose Tolerance During Pregnancy</brief_title>
  <official_title>Effects of Stress on Glucose Tolerance During Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Lausanne Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Lausanne Hospitals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to investigate the effect of stress on glucose tolerance during&#xD;
      pregnancy.&#xD;
&#xD;
      The main objectives of the study are to investigate if various measures of stress (stressful&#xD;
      life events, the perceived level of stress and the cortisol or copeptin concentrations)&#xD;
      differ between pregnant women with and without gestational diabetes during the end of the&#xD;
      second/beginning of the third trimester when presenting for their routine glucose tolerance&#xD;
      testing.&#xD;
&#xD;
      Secondary objectives are the link between these different stress measures and the routinely&#xD;
      measured fasting and stimulated glucose levels during the oral glucose tolerance test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypotheses in this study, 3 primary hypotheses will be tested.&#xD;
&#xD;
        1. Women with gestational diabetes have more life events compared to pregnant women without&#xD;
           gestational diabetes.&#xD;
&#xD;
        2. Women with gestational diabetes have higher perceived level of stress and anxiety&#xD;
           compared to pregnant women without gestational diabetes.&#xD;
&#xD;
        3. Women with gestational diabetes have higher measures of cortisol levels in the saliva&#xD;
           and in the nailfolds and higher plasma copeptin levels compared to pregnant women&#xD;
           without gestational diabetes.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
      1. To test the link between these stress measures and the fasting and stimulated glucose&#xD;
      levels during the oral glucose tolerance test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Markers of stress</measure>
    <time_frame>At assessment</time_frame>
    <description>stress (stressful life events, the perceived level of stress and the cortisol or copeptin concentrations)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">203</enrollment>
  <condition>Pregnancy</condition>
  <condition>Stress</condition>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>Women with gestational diabetes</arm_group_label>
    <description>Women with gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Women without gestational diabetes</arm_group_label>
    <description>Women without gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All pregnant women who are undergoing a 75 g oral glucose tolerance test at the&#xD;
             &quot;Maternité&quot; of CHUV at 24-30 weeks of gestation between October 2012 and April 2013&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman who has the use if medications that influence either the cortisol and&#xD;
             /or the glucose levels&#xD;
&#xD;
          -  Pregnant woman who has the inability to fill out the questionnaires with assistance&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jardena J. Puder, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Lausanne</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ji-Seon Kang</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Lausanne</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yvan Vial, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Lausanne</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pr Ulrike Ehlert, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ayala Borghini, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Lausanne</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pedro Marques-Vidal, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Lausanne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maternité CHUV, University of Lausanne</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne Hospitals</investigator_affiliation>
    <investigator_full_name>Jardena Puder</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Stress</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Cortisol</keyword>
  <keyword>Copeptin</keyword>
  <keyword>Gestational diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
  </condition_browse>
  <!-- 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/NCT01707784
org study id: 295/12
nct id: NCT01707784
lead sponsor: 
has dmc: No
The objective of the study is to investigate the effect of stress on glucose tolerance during
      pregnancy.

      The main objectives of the study are to investigate if various measures of stress (stressful
      life events, the perceived level of stress and the cortisol or copeptin concentrations)
      differ between pregnant women with and without gestational diabetes during the end of the
      second/beginning of the third trimester when presenting for their routine glucose tolerance
      testing.

      Secondary objectives are the link between these different stress measures and the routinely
      measured fasting and stimulated glucose levels during the oral glucose tolerance test.
Hypotheses in this study, 3 primary hypotheses will be tested.

        1. Women with gestational diabetes have more life events compared to pregnant women without
           gestational diabetes.

        2. Women with gestational diabetes have higher perceived level of stress and anxiety
           compared to pregnant women without gestational diabetes.

        3. Women with gestational diabetes have higher measures of cortisol levels in the saliva
           and in the nailfolds and higher plasma copeptin levels compared to pregnant women
           without gestational diabetes.

      Secondary objectives:

      1. To test the link between these stress measures and the fasting and stimulated glucose
      levels during the oral glucose tolerance test.
observational model: Cohort
time perspective: Cross-Sectional
measure: Markers of stress
time frame: At assessment
description: stress (stressful life events, the perceived level of stress and the cortisol or copeptin concentrations)
arm group label: Women with gestational diabetes
description: Women with gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing
arm group label: Women without gestational diabetes
description: Women without gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jardena J. Puder, MD
role: Study Director
affiliation: University of Lausanne
last name: Ji-Seon Kang
role: Principal Investigator
affiliation: University of Lausanne
last name: Yvan Vial, MD
role: Principal Investigator
affiliation: University of Lausanne
last name: Pr Ulrike Ehlert, PhD
role: Principal Investigator
affiliation: University of Zurich
last name: Ayala Borghini, PhD
role: Principal Investigator
affiliation: University of Lausanne
last name: Pedro Marques-Vidal, MD, PhD
role: Principal Investigator
affiliation: University of Lausanne
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Lausanne Hospitals
investigator full name: Jardena Puder
investigator title: MD
mesh term: Diabetes, Gestational