<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/NCT02183558</url>
  </required_header>
  <id_info>
    <org_study_id>GDM OBK</org_study_id>
    <secondary_id>Glucose OBK</secondary_id>
    <nct_id>NCT02183558</nct_id>
  </id_info>
  <brief_title>Screening for GDM in Women With PCOS and Controls</brief_title>
  <official_title>Glucose Metabolism and Screening for Gestational Diabetes Mellitus According to Different Sets of Criteria in Women With Polycystic Ovary Syndrome and Controls</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Municipality of Odense</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Women with polycystic ovary syndrome (PCOS) are often insulin resistant. During pregnancy,&#xD;
      insulin sensitivity decreases. The investigators examine glucose metabolism during oral&#xD;
      glucose tolerance test and the incidense of gestational diabetes mellitus in a prospective&#xD;
      cohort of pregnant women with PCOS and controls.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gestational diabetes mellitus</measure>
    <time_frame>2 years</time_frame>
    <description>Gestational diabetes mellitus diagnosed by oral glucose tolerance test in gestational week 28 in women with and without risk factors for gestational diabetes mellitus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gestational Diabetes Mellitus</measure>
    <time_frame>Gestational week 28</time_frame>
    <description>Gestational diabetes mellitus is diagnosed by 2 hour 75 gram oral glucose tolerance test in gestational week 28</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anthropometric measures in offspring</measure>
    <time_frame>At birth</time_frame>
    <description>The association between blood glucose values and anthropometric measures (birth length, weight and abdominal circumference) at birth in the offspring is investigated</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2500</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <condition>Gestational Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>OGTT by randomization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women without risk factors for GDM are offered OGTT in gestational week 28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OGTT by indication</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women with risk factors for OGTT are offered diagnostic 2 hour OGTT in pregnancy week 28</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>OGTT by randomization</intervention_name>
    <arm_group_label>OGTT by randomization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>OGTT by indication</intervention_name>
    <arm_group_label>OGTT by indication</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnancy achieved during 2010-2012&#xD;
&#xD;
          -  Residents of the municipality of Odense&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Moving from Odense during pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marianne Andersen, DMSci</last_name>
    <role>Principal Investigator</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OdenseUH</name>
      <address>
        <city>Odense</city>
        <zip>5230</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>December 23, 2021</last_update_submitted>
  <last_update_submitted_qc>December 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Marianne Andersen</investigator_full_name>
    <investigator_title>DMSci</investigator_title>
  </responsible_party>
  <keyword>PCOS</keyword>
  <keyword>GDM</keyword>
  <keyword>OGTT</keyword>
  <keyword>Glucose metabolism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Syndrome</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/NCT02183558
org study id: GDM OBK
secondary id: Glucose OBK
nct id: NCT02183558
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Women with polycystic ovary syndrome (PCOS) are often insulin resistant. During pregnancy,
      insulin sensitivity decreases. The investigators examine glucose metabolism during oral
      glucose tolerance test and the incidense of gestational diabetes mellitus in a prospective
      cohort of pregnant women with PCOS and controls.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Gestational diabetes mellitus
time frame: 2 years
description: Gestational diabetes mellitus diagnosed by oral glucose tolerance test in gestational week 28 in women with and without risk factors for gestational diabetes mellitus.
measure: Gestational Diabetes Mellitus
time frame: Gestational week 28
description: Gestational diabetes mellitus is diagnosed by 2 hour 75 gram oral glucose tolerance test in gestational week 28
measure: Anthropometric measures in offspring
time frame: At birth
description: The association between blood glucose values and anthropometric measures (birth length, weight and abdominal circumference) at birth in the offspring is investigated
arm group label: OGTT by randomization
arm group type: Experimental
description: Women without risk factors for GDM are offered OGTT in gestational week 28
arm group label: OGTT by indication
arm group type: Experimental
description: Women with risk factors for OGTT are offered diagnostic 2 hour OGTT in pregnancy week 28
intervention type: Other
intervention name: OGTT by randomization
arm group label: OGTT by randomization
intervention type: Other
intervention name: OGTT by indication
arm group label: OGTT by indication
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marianne Andersen, DMSci
role: Principal Investigator
affiliation: Odense University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Marianne Andersen
investigator title: DMSci
mesh term: Polycystic Ovary Syndrome
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
mesh term: Syndrome