xml: <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/NCT05992974</url>
    </required_header>
    <id_info>
      <org_study_id>202303075GDM</org_study_id>
      <secondary_id>K4087</secondary_id>
      <nct_id>NCT05992974</nct_id>
    </id_info>
    <brief_title>To Identify Urinary Biomarkers Associated With Gestational Diabetes Mellitus [GDM]</brief_title>
    <official_title>To Identify Urinary Biomarkers in the First Trimester Associated With Gestational Diabetes Mellitus [GDM] and Achieve Early Diagnosis of GDM Using Urinary Proteomic Analysis: An Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Mudanjiang First People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Mudanjiang Maternal and Child Health Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Peking Union Medical College Hospital</source>
    <oversight_info>
      <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) is one of the most common complications of pregnancy. The&#xD;
        incidence of GDM is higher in Asian than in other regions, and GDM can increase the risk of a&#xD;
        series of perinatal complications. The investigators has been committed to the early&#xD;
        diagnosis of GDM, and several biomarkers in the first trimester and urinary proteomic markers&#xD;
        that were associated with GDM have been found. Based on the previous work, the aim of this&#xD;
        study was to verify the predictive ability of urinary proteomic markers for GDM that has been&#xD;
        found in the previous study of the researchers. This study is a multi-center, prospective,&#xD;
        and observational study. Urine samples will be collected twice, at 12 weeks and 24-28 weeks&#xD;
        of gestation, respectively.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The eligibility criteria are as follows:&#xD;
  &#xD;
          1. singleton pregnant women over 18 years old;&#xD;
  &#xD;
          2. gestational age less than 12 weeks;&#xD;
  &#xD;
          3. regular follow-up until delivery;&#xD;
  &#xD;
          4. able to understand and sign an informed consent.&#xD;
  &#xD;
        The exclusion criteria of pregnant women are as follows:&#xD;
  &#xD;
          1. with impaired glucose tolerance or diabetes mellitus before pregnancy;&#xD;
  &#xD;
          2. severe chronic diseases or infectious diseases (e.g., liver disease, urinary system&#xD;
             disease, cardiovascular disease, autoimmune disease, hematological disease, AIDS and&#xD;
             other diseases before pregnancy);&#xD;
  &#xD;
          3. medications other than vitamins used during pregnancy;&#xD;
  &#xD;
          4. inability to understand and follow-up regularly;&#xD;
  &#xD;
          5. other conditions judged by the investigators to be inappropriate for participation in&#xD;
             the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>Number of participants with gestational diabetes</measure>
      <time_frame>at 24-28 weeks of gestation</time_frame>
      <description>Diagnosed by 75g-OGTT at 24-28 weeks of gestation. GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criterion in 2010: fasting blood glucose ≥5.1mmol/L, and/or 1-hour blood glucose ≥10.0mmol/L, and/or 2-hour blood glucose ≥8.5mmol/L</description>
    </primary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Gestational Diabetes</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Our study population was pregnant women in early pregnancy who regularly visited the&#xD;
          following two medical center: Mudanjiang First People's Hospital, and Mudanjiang Maternal&#xD;
          and Child Health Care Hospital. All pregnant women within 12 gestational weeks are eligible&#xD;
          for enrollment, and whether entry or not depends on their own preference. There were no&#xD;
          requirements for household registration, place of residence, and other identify&#xD;
          informations of the enrolled women.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women of childbearing age who are in early pregnancy(gestational age less than 12&#xD;
               weeks);&#xD;
  &#xD;
            -  Regular prenatal examination until delivery;&#xD;
  &#xD;
            -  Older than 18 years old;&#xD;
  &#xD;
            -  Obtained informed consent from participants and/or their family members.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Twins or multiple pregnancy;&#xD;
  &#xD;
            -  With impaired glucose tolerance or diabetes mellitus before pregnancy;&#xD;
  &#xD;
            -  With severe chronic diseases or infectious diseases (e.g., liver disease, urinary&#xD;
               system disease, cardiovascular disease, autoimmune disease, hematological disease,&#xD;
               AIDS and other diseases before pregnancy);&#xD;
  &#xD;
            -  Medications other than vitamins used during pregnancy;&#xD;
  &#xD;
            -  Inability to understand and follow-up regularly;&#xD;
  &#xD;
            -  Other conditions that were judged by the investigator to be ineligible for&#xD;
               participation in the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Tedros Adhanom Ghebreyesus</last_name>
      <role>Principal Investigator</role>
      <affiliation>World Health Organization</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yanbei Duo, Dr.</last_name>
      <phone>86+15561852093</phone>
      <email>duoduo15561852093@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mudanjiang First People's Hospital</name>
        <address>
          <city>Mudanjiang</city>
          <state>Heilongjiang</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yanbei Duo, Dr.</last_name>
        <phone>86+15561852093</phone>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Wang X, Zhao M, Guo Z, Song S, Liu S, Yuan T, Fu Y, Dong Y, Sun H, Liu X, Zhou D, Zhao W, Sun W. Urinary proteomic analysis during pregnancy and its potential application in early prediction of gestational diabetes mellitus and spontaneous abortion. Ann Transl Med. 2022 Jul;10(13):736. doi: 10.21037/atm-21-3497.</citation>
      <PMID>35957715</PMID>
    </results_reference>
    <results_reference>
      <citation>Song S, Duo Y, Zhang Y, Qiao X, Xu J, Zhang J, Peng Z, Chen Y, Nie X, Sun Q, Yang X, Wang A, Sun W, Fu Y, Dong Y, Lu Z, Yuan T, Zhao W. The Predictive Ability of Hepatic Steatosis Index for Gestational Diabetes Mellitus and Large for Gestational Age Infant Compared with Other Noninvasive Indices Among Chinese Pregnancies: A Preliminary Double-center Cohort Study. Diabetes Metab Syndr Obes. 2021 Dec 16;14:4791-4800. doi: 10.2147/DMSO.S335364. eCollection 2021.</citation>
      <PMID>34938090</PMID>
    </results_reference>
    <results_reference>
      <citation>Song S, Zhang Y, Qiao X, Duo Y, Xu J, Peng Z, Zhang J, Chen Y, Nie X, Sun Q, Yang X, Lu Z, Liu S, Zhao T, Yuan T, Fu Y, Dong Y, Zhao W, Sun W, Wang A. HOMA-IR as a risk factor of gestational diabetes mellitus and a novel simple surrogate index in early pregnancy. Int J Gynaecol Obstet. 2022 Jun;157(3):694-701. doi: 10.1002/ijgo.13905. Epub 2021 Sep 24.</citation>
      <PMID>34449903</PMID>
    </results_reference>
    <results_reference>
      <citation>Duo Y, Song S, Zhang Y, Qiao X, Xu J, Zhang J, Peng Z, Chen Y, Nie X, Sun Q, Yang X, Wang A, Sun W, Fu Y, Dong Y, Lu Z, Yuan T, Zhao W. Predictability of HOMA-IR for Gestational Diabetes Mellitus in Early Pregnancy Based on Different First Trimester BMI Values. J Pers Med. 2022 Dec 28;13(1):60. doi: 10.3390/jpm13010060.</citation>
      <PMID>36675721</PMID>
    </results_reference>
    <results_reference>
      <citation>Song S, Zhang Y, Qiao X, Duo Y, Xu J, Peng Z, Zhang J, Chen Y, Nie X, Sun Q, Yang X, Wang A, Lu Z, Sun W, Fu Y, Dong Y, Yuan T, Zhao W. ALT/AST as an Independent Risk Factor of Gestational Diabetes Mellitus Compared with TG/HDL-C. Int J Gen Med. 2022 Jan 5;15:115-121. doi: 10.2147/IJGM.S332946. eCollection 2022.</citation>
      <PMID>35023950</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>gestational diabetes</keyword>
    <keyword>urinary proteomics</keyword>
    <keyword>early prediction</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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992974
  org study id: 202303075GDM
  secondary id: K4087
  nct id: NCT05992974
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Gestational diabetes mellitus(GDM) is one of the most common complications of pregnancy. The
        incidence of GDM is higher in Asian than in other regions, and GDM can increase the risk of a
        series of perinatal complications. The investigators has been committed to the early
        diagnosis of GDM, and several biomarkers in the first trimester and urinary proteomic markers
        that were associated with GDM have been found. Based on the previous work, the aim of this
        study was to verify the predictive ability of urinary proteomic markers for GDM that has been
        found in the previous study of the researchers. This study is a multi-center, prospective,
        and observational study. Urine samples will be collected twice, at 12 weeks and 24-28 weeks
        of gestation, respectively.
  The eligibility criteria are as follows:
  
          1. singleton pregnant women over 18 years old;
  
          2. gestational age less than 12 weeks;
  
          3. regular follow-up until delivery;
  
          4. able to understand and sign an informed consent.
  
        The exclusion criteria of pregnant women are as follows:
  
          1. with impaired glucose tolerance or diabetes mellitus before pregnancy;
  
          2. severe chronic diseases or infectious diseases (e.g., liver disease, urinary system
             disease, cardiovascular disease, autoimmune disease, hematological disease, AIDS and
             other diseases before pregnancy);
  
          3. medications other than vitamins used during pregnancy;
  
          4. inability to understand and follow-up regularly;
  
          5. other conditions judged by the investigators to be inappropriate for participation in
             the study.
  observational model: Cohort
  time perspective: Prospective
  measure: Number of participants with gestational diabetes
  time frame: at 24-28 weeks of gestation
  description: Diagnosed by 75g-OGTT at 24-28 weeks of gestation. GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criterion in 2010: fasting blood glucose ≥5.1mmol/L, and/or 1-hour blood glucose ≥10.0mmol/L, and/or 2-hour blood glucose ≥8.5mmol/L
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  last name: Tedros Adhanom Ghebreyesus
  role: Principal Investigator
  affiliation: World Health Organization
  last name: Yanbei Duo, Dr.
  phone: 86+15561852093
  email: duoduo15561852093@163.com
  facility: 
  contact: 
  country: China
  citation: Wang X, Zhao M, Guo Z, Song S, Liu S, Yuan T, Fu Y, Dong Y, Sun H, Liu X, Zhou D, Zhao W, Sun W. Urinary proteomic analysis during pregnancy and its potential application in early prediction of gestational diabetes mellitus and spontaneous abortion. Ann Transl Med. 2022 Jul;10(13):736. doi: 10.21037/atm-21-3497.
  PMID: 35957715
  citation: Song S, Duo Y, Zhang Y, Qiao X, Xu J, Zhang J, Peng Z, Chen Y, Nie X, Sun Q, Yang X, Wang A, Sun W, Fu Y, Dong Y, Lu Z, Yuan T, Zhao W. The Predictive Ability of Hepatic Steatosis Index for Gestational Diabetes Mellitus and Large for Gestational Age Infant Compared with Other Noninvasive Indices Among Chinese Pregnancies: A Preliminary Double-center Cohort Study. Diabetes Metab Syndr Obes. 2021 Dec 16;14:4791-4800. doi: 10.2147/DMSO.S335364. eCollection 2021.
  PMID: 34938090
  citation: Song S, Zhang Y, Qiao X, Duo Y, Xu J, Peng Z, Zhang J, Chen Y, Nie X, Sun Q, Yang X, Lu Z, Liu S, Zhao T, Yuan T, Fu Y, Dong Y, Zhao W, Sun W, Wang A. HOMA-IR as a risk factor of gestational diabetes mellitus and a novel simple surrogate index in early pregnancy. Int J Gynaecol Obstet. 2022 Jun;157(3):694-701. doi: 10.1002/ijgo.13905. Epub 2021 Sep 24.
  PMID: 34449903
  citation: Duo Y, Song S, Zhang Y, Qiao X, Xu J, Zhang J, Peng Z, Chen Y, Nie X, Sun Q, Yang X, Wang A, Sun W, Fu Y, Dong Y, Lu Z, Yuan T, Zhao W. Predictability of HOMA-IR for Gestational Diabetes Mellitus in Early Pregnancy Based on Different First Trimester BMI Values. J Pers Med. 2022 Dec 28;13(1):60. doi: 10.3390/jpm13010060.
  PMID: 36675721
  citation: Song S, Zhang Y, Qiao X, Duo Y, Xu J, Peng Z, Zhang J, Chen Y, Nie X, Sun Q, Yang X, Wang A, Lu Z, Sun W, Fu Y, Dong Y, Yuan T, Zhao W. ALT/AST as an Independent Risk Factor of Gestational Diabetes Mellitus Compared with TG/HDL-C. Int J Gen Med. 2022 Jan 5;15:115-121. doi: 10.2147/IJGM.S332946. eCollection 2022.
  PMID: 35023950
  responsible party type: Sponsor
  mesh term: Diabetes, Gestational
  mesh term: Diabetes Mellitus
  sharing ipd: No