<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/NCT03246295</url>
  </required_header>
  <id_info>
    <org_study_id>ZS976</org_study_id>
    <nct_id>NCT03246295</nct_id>
  </id_info>
  <brief_title>Identification of Gestational Diabetes Mellitus Related Urinary Biomarkers Along Pregnancy (From Early Pregnancy to Postpartum) by Using Proteomics and Metabolomics Analysis</brief_title>
  <official_title>Identification of Gestational Diabetes Mellitus Related Urinary Biomarkers Along Pregnancy (From Early Pregnancy to Postpartum) by Using Proteomics and Metabolomics Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Gestational diabetes mellitus (GDM) has many adverse effects on pregnant women and fetuses.&#xD;
      At present, no prediction marker for GDM in early pregnancy is accepted. There is still a&#xD;
      lack of recognized early predictors. This study was designed to identity valuable biomarkers&#xD;
      for GDM.This was a prospective observed cohort study. 140 pregnant women were recruited in&#xD;
      early pregnancy, and followed up to 6 weeks postpartum. Glucose challenge test and 75g oral&#xD;
      glucose tolerance test were performed after 24 weeks of pregnancy, and GDM was diagnosed&#xD;
      according to the latest ADA standard. Urinary samples were collected in the first (&lt;12&#xD;
      weeks), second (24~28 weeks) and third (32~weeks) trimester of pregnancy. Urinary proteomics&#xD;
      and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass&#xD;
      spectrometry. 15 cases of GDM women and 50 cases of control women were used for longitudinal&#xD;
      analysis; 15 cases of GDM women and 15 cases of age matched control women were used for&#xD;
      difference analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 20, 2015</start_date>
  <completion_date type="Anticipated">October 1, 2017</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary samples were analyzed</measure>
    <time_frame>in the first (&lt;12 weeks) trimester of pregnancy</time_frame>
    <description>Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary samples were analyzed</measure>
    <time_frame>in the second (24-28 weeks) trimester of pregnancy</time_frame>
    <description>Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary samples were analyzed</measure>
    <time_frame>in the third (&gt;32 weeks) trimester of pregnancy</time_frame>
    <description>Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">140</enrollment>
  <condition>Gestational Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Gestational diabetes mellitus</arm_group_label>
    <description>Those women were diagnosed as gestational diabetes mellitus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Those women were diagnosed without gestational diabetes mellitus</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>lifestyle intervention or insulin treatment</intervention_name>
    <description>Firstly，the gestational diabetes mellitus（GDM） women were treated with lifestyle intervention.Those women were treated with insulin if their blood glucose was not well Controled.</description>
    <arm_group_label>Gestational diabetes mellitus</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urinary samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women were recruited in early pregnancy, and followed up to 6 weeks postpartum&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Pregnant women （&lt;12 weeks）&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with renal dysfunction&#xD;
&#xD;
          -  urine routine examination abnormalities for twice&#xD;
&#xD;
          -  history of urinary and reproductive system diseases&#xD;
&#xD;
          -  with other chronic diseases&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>wuxueyan</investigator_full_name>
    <investigator_title>professor，MD</investigator_title>
  </responsible_party>
  <keyword>Proteomics</keyword>
  <keyword>Metabolomics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
  </intervention_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/NCT03246295
org study id: ZS976
nct id: NCT03246295
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Gestational diabetes mellitus (GDM) has many adverse effects on pregnant women and fetuses.
      At present, no prediction marker for GDM in early pregnancy is accepted. There is still a
      lack of recognized early predictors. This study was designed to identity valuable biomarkers
      for GDM.This was a prospective observed cohort study. 140 pregnant women were recruited in
      early pregnancy, and followed up to 6 weeks postpartum. Glucose challenge test and 75g oral
      glucose tolerance test were performed after 24 weeks of pregnancy, and GDM was diagnosed
      according to the latest ADA standard. Urinary samples were collected in the first (<12
      weeks), second (24~28 weeks) and third (32~weeks) trimester of pregnancy. Urinary proteomics
      and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass
      spectrometry. 15 cases of GDM women and 50 cases of control women were used for longitudinal
      analysis; 15 cases of GDM women and 15 cases of age matched control women were used for
      difference analysis.
observational model: Cohort
time perspective: Prospective
measure: Urinary samples were analyzed
time frame: in the first (<12 weeks) trimester of pregnancy
description: Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.
measure: Urinary samples were analyzed
time frame: in the second (24-28 weeks) trimester of pregnancy
description: Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.
measure: Urinary samples were analyzed
time frame: in the third (>32 weeks) trimester of pregnancy
description: Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.
arm group label: Gestational diabetes mellitus
description: Those women were diagnosed as gestational diabetes mellitus
arm group label: Control
description: Those women were diagnosed without gestational diabetes mellitus
intervention type: Other
intervention name: lifestyle intervention or insulin treatment
description: Firstly，the gestational diabetes mellitus（GDM） women were treated with lifestyle intervention.Those women were treated with insulin if their blood glucose was not well Controled.
arm group label: Gestational diabetes mellitus
Urinary samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women
minimum age: 18 Years
maximum age: 45 Years
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: wuxueyan
investigator title: professor，MD
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
mesh term: Insulin