<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/NCT02184676</url>
  </required_header>
  <id_info>
    <org_study_id>P130405</org_study_id>
    <secondary_id>ID RCB : 2014-A00453-44</secondary_id>
    <nct_id>NCT02184676</nct_id>
  </id_info>
  <brief_title>T1D Risk Assessment in Kids With Relatives</brief_title>
  <acronym>TRAKR</acronym>
  <official_title>Early Immunological, Metagenomic, Metabolic and Environmental Factors in the Progression to Type 1 Diabetes: the TRAKR Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé et de la Recherche Médicale (INSERM) U1016 - Institut Cochin, Immunology of Diabetes Team, Paris, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>INSERM U1153, Epidemiology Research Unit on Perinatal Health and Women and Children Health, Port-Royal Hospital, Paris, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Commissariat A L'energie Atomique</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether early immunological markers (activation of&#xD;
      autoreactive T lymphocytes) precede and are predictive of the appearance of autoantibodies in&#xD;
      children born from type 1 diabetic parents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of type 1 diabetes (T1D) is estimated between 0.2 and 0.4% in France. The&#xD;
      incidence in France is more than 10/105 per year, with a steady increase (~4%/year),&#xD;
      especially in children. Infants born to parents with T1D have a 15-fold higher risk to&#xD;
      develop T1D compared to the general population. The appearance of autoantibodies precedes and&#xD;
      is highly predictive of the later occurrence of T1D. The activation of B lymphocytes, which&#xD;
      produce autoantibodies, is controlled by T helper lymphocytes. Hence, biomarkers associated&#xD;
      with initial T lymphocyte activation are likely to precede the appearance of autoantibodies.&#xD;
&#xD;
      The aim of the TRAKR study is to determine whether the appearance of autoreactive T&#xD;
      lymphocytes is predictive of the emergence of autoantibodies.&#xD;
&#xD;
      The secondary objectives are: 1) to evaluate whether metagenomic, metabolic, or environmental&#xD;
      factors are associated with the appearance of autoantibodies; 2) to evaluate the incidence&#xD;
      and the time of autoantibody appearance in a French population of genetically at-risk&#xD;
      children; 3) to compare the incidence of autoantibodies between infants born to T1D fathers&#xD;
      and mothers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 28, 2015</start_date>
  <completion_date type="Actual">May 17, 2019</completion_date>
  <primary_completion_date type="Actual">May 17, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Autoreactive T lymphocytes</measure>
    <time_frame>48 months</time_frame>
    <description>presence, frequency, antigen specificity, phenotype</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metagenomic signatures</measure>
    <time_frame>48 months</time_frame>
    <description>presence, frequency, type</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic signatures</measure>
    <time_frame>48 months</time_frame>
    <description>presence, frequency, type</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Environmental factors</measure>
    <time_frame>48 months</time_frame>
    <description>Sociodemographic characteristics, e.g. age, gender, occupation, living place, family situation, number of children, education, housing type, animal contact&#xD;
Family history, e.g. autoimmune diseases&#xD;
Personal history, e.g. diabetes characteristics, associated co-morbidities, obstetrical history&#xD;
Clinical data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of autoantibodies</measure>
    <time_frame>48 months</time_frame>
    <description>Presence, titer, specificity</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">512</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Children born to mother/father with type 1 diabetes</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Analysis of early immune modifications</intervention_name>
    <description>blood and stool sampling in parents during pregnancy (at enrollment, i.e. 7th-8th month of pregnancy)&#xD;
cord blood sampling&#xD;
stool sampling in mothers and newborns at birth (day 7)&#xD;
blood and stool sampling in children at the age of 8, 18, 30 and 42 months</description>
    <arm_group_label>Children born to mother/father with type 1 diabetes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collection of clinical and socio-demographic data</intervention_name>
    <description>Questionnaire filled in by clinicians at enrollment and at birth&#xD;
Self-administered questionnaire filled by parents at enrollment, at birth, and then at month 8, 18, 30 and 42</description>
    <arm_group_label>Children born to mother/father with type 1 diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Mother and/or father with type 1 diabetes&#xD;
&#xD;
               -  age &gt; 18 years&#xD;
&#xD;
               -  type 1 diabetes : insulin-dependent diabetes positive for autoantibodies against&#xD;
                  insulin and/or GAD and/or IA-2 and/or ZnT8 at the time of diagnosis&#xD;
&#xD;
               -  planning to give birth or having given birth since less than 8 months&#xD;
&#xD;
               -  agreeing to participate upon written informed consent&#xD;
&#xD;
               -  covered by the French social security system&#xD;
&#xD;
          2. Mother/father without Type 1 diabetes&#xD;
&#xD;
               -  age &gt; 18 years old&#xD;
&#xD;
               -  with a spouse with type 1 diabetes : insulin-dependent diabetes positive for&#xD;
                  autoantibodies against insulin and/or GAD and/or IA-2 and/or ZnT8 at the time of&#xD;
                  diagnosis&#xD;
&#xD;
               -  planning to give birth or having given birth since less than 8 months&#xD;
&#xD;
               -  agreeing to participate upon written informed consent&#xD;
&#xD;
               -  covered by the French social security system&#xD;
&#xD;
          3. Children born to mother and/or father with type 1 diabetes&#xD;
&#xD;
               -  age &lt; 8 months&#xD;
&#xD;
               -  with at least one parent with T1D&#xD;
&#xD;
               -  with both parents agreeing to participate&#xD;
&#xD;
               -  both parents covered by the French social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Mother/father&#xD;
&#xD;
          -  secondary forms of diabetes&#xD;
&#xD;
          -  monogenic forms of diabetes&#xD;
&#xD;
             1 or 2) For the mother&#xD;
&#xD;
          -  malignant neoplastic or psychiatric disease&#xD;
&#xD;
             3 ) Newborns of mother/father with type 1 diabetes&#xD;
&#xD;
          -  Severe foetal disease&#xD;
&#xD;
          -  Severe congenital malformation&#xD;
&#xD;
          -  Congenital measles&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roberto Mallone, M.D, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>INSERM U1016</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cochin Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>April 2, 2021</last_update_submitted>
  <last_update_submitted_qc>April 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 1 diabetes</keyword>
  <keyword>risk assessment</keyword>
  <keyword>immunological marker</keyword>
  <keyword>children</keyword>
  <keyword>relatives</keyword>
  <keyword>autoantibodies</keyword>
  <keyword>lymphocytes</keyword>
  <keyword>T cells</keyword>
  <keyword>epitopes</keyword>
  <keyword>Children born to mother/father with type 1 diabetes and their parents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</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/NCT02184676
org study id: P130405
secondary id: ID RCB : 2014-A00453-44
nct id: NCT02184676
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether early immunological markers (activation of
      autoreactive T lymphocytes) precede and are predictive of the appearance of autoantibodies in
      children born from type 1 diabetic parents.
The prevalence of type 1 diabetes (T1D) is estimated between 0.2 and 0.4% in France. The
      incidence in France is more than 10/105 per year, with a steady increase (~4%/year),
      especially in children. Infants born to parents with T1D have a 15-fold higher risk to
      develop T1D compared to the general population. The appearance of autoantibodies precedes and
      is highly predictive of the later occurrence of T1D. The activation of B lymphocytes, which
      produce autoantibodies, is controlled by T helper lymphocytes. Hence, biomarkers associated
      with initial T lymphocyte activation are likely to precede the appearance of autoantibodies.

      The aim of the TRAKR study is to determine whether the appearance of autoreactive T
      lymphocytes is predictive of the emergence of autoantibodies.

      The secondary objectives are: 1) to evaluate whether metagenomic, metabolic, or environmental
      factors are associated with the appearance of autoantibodies; 2) to evaluate the incidence
      and the time of autoantibody appearance in a French population of genetically at-risk
      children; 3) to compare the incidence of autoantibodies between infants born to T1D fathers
      and mothers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Autoreactive T lymphocytes
time frame: 48 months
description: presence, frequency, antigen specificity, phenotype
measure: Metagenomic signatures
time frame: 48 months
description: presence, frequency, type
measure: Metabolic signatures
time frame: 48 months
description: presence, frequency, type
measure: Environmental factors
time frame: 48 months
description: Sociodemographic characteristics, e.g. age, gender, occupation, living place, family situation, number of children, education, housing type, animal contact
Family history, e.g. autoimmune diseases
Personal history, e.g. diabetes characteristics, associated co-morbidities, obstetrical history
Clinical data
measure: Incidence of autoantibodies
time frame: 48 months
description: Presence, titer, specificity
arm group label: Children born to mother/father with type 1 diabetes
arm group type: Other
intervention type: Biological
intervention name: Analysis of early immune modifications
description: blood and stool sampling in parents during pregnancy (at enrollment, i.e. 7th-8th month of pregnancy)
cord blood sampling
stool sampling in mothers and newborns at birth (day 7)
blood and stool sampling in children at the age of 8, 18, 30 and 42 months
arm group label: Children born to mother/father with type 1 diabetes
intervention type: Other
intervention name: Collection of clinical and socio-demographic data
description: Questionnaire filled in by clinicians at enrollment and at birth
Self-administered questionnaire filled by parents at enrollment, at birth, and then at month 8, 18, 30 and 42
arm group label: Children born to mother/father with type 1 diabetes
criteria: 
gender: All
minimum age: 1 Day
maximum age: N/A
healthy volunteers: No
last name: Roberto Mallone, M.D, Ph.D.
role: Principal Investigator
affiliation: INSERM U1016
facility: 
country: France
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No