<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/NCT03269084</url>
  </required_header>
  <id_info>
    <org_study_id>1-SRA-2016-342-M-R</org_study_id>
    <nct_id>NCT03269084</nct_id>
  </id_info>
  <brief_title>Type 1 Diabetes Prediction and Prevention (DIPP) Study</brief_title>
  <acronym>DIPP</acronym>
  <official_title>Type 1 Diabetes Prediction and Prevention (DIPP) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Riitta Veijola</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oulu University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Turku</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tampere University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tampere University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Juvenile Diabetes Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Leona M. and Harry B. Helmsley Charitable Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oulu</source>
  <oversight_info>
    <has_dmc>No</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>
      The Type 1 Diabetes Prediction and Prevention (DIPP) Study in Finland is a population-based&#xD;
      long-term clinical follow-up study established since 1994 in three university hospitals in&#xD;
      Finland to understand the pathogenesis of type 1 diabetes (T1D), predict the disease, and&#xD;
      find preventive treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Briefly, cord blood samples are collected and HLA-DR-DQ genotypes are determined from newborn&#xD;
      babies. Families with a newborn baby carrying a DR-DQ genotype associated with increased risk&#xD;
      for T1D are invited to participate in regular follow-up at the age of 3, 6, 9, 12, 18 and 24&#xD;
      months, and thereafter once a year until the age of 15 years or until T1D is diagnosed.&#xD;
      Clinical details including maternal diet during pregnancy and lactation and child's diet&#xD;
      starting from the age of 3 months are recorded, blood samples are collected, and serum&#xD;
      autoantibodies associated with development of T1D are measured. Children who develop&#xD;
      beta-cell specific autoimmunity are followed more intensively with measurements of glucose&#xD;
      metabolism parameters such as glycated haemoglobin A1c (HbA1c), oral glucose tolerance tests&#xD;
      (OGTT) and intravenous glucose tolerance tests (IVGTT). In the DIPP Study more than 1000&#xD;
      children have developed multiple islet autoantibodies and more than 450 of these have&#xD;
      progressed to clinical T1D. It has been estimated that 5% of children in the follow-up will&#xD;
      develop T1D and 60% of future T1D cases will be reached by the current screening and&#xD;
      follow-up strategy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 7, 1994</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>Positivity for at least one islet autoantibody</measure>
    <time_frame>December 31, 2021</time_frame>
    <description>ICA, IAA, GADA, IA-2A or ZnT8A</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical diagnosis of type 1 diabetes</measure>
    <time_frame>December 31, 2021</time_frame>
    <description>Hyperglycemia as defined by WHO</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">17000</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Children at HLA-conferred risk for T1D</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention. DIPP is an observational study.</intervention_name>
    <arm_group_label>Children at HLA-conferred risk for T1D</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Since November 1994 the Finnish Type 1 Diabetes Prediction and Prevention (DIPP) Study has&#xD;
        screened 206,707 newborns for HLA-conferred genetic susceptibility for T1D (Figure 1., data&#xD;
        as of March 2015). A total of 16,193 children have started clinical follow-up with regular&#xD;
        study visits and systematic collection of longitudinal blood and stool samples. Altogether&#xD;
        more than 1000 children have seroconverted to positivity for multiple islet autoantibodies&#xD;
        (ICA included). A total of 461 children and adolescents have progressed to clinical T1D&#xD;
        with DIPP follow-up from birth until diagnosis. Currently there are 7158 children between 3&#xD;
        months and 15 years of age taking part in the DIPP Study follow-up.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newborn babies with HLA-conferred genetic susceptibility to type 1 diabetes born in&#xD;
             three University Hospitals in Finland&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Newborn babies without HLA-conferred genetic susceptibility to type 1 diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Riitta Veijola, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oulu, Oulu University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mikael Knip, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Helsinki, Tampere University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jorma Toppari, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Turku, Turku University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kalle Kurppa, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tampere University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Heikki Hyöty, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tampere University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Johanna Lempainen, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Turku</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Riitta Veijola, MD PhD</last_name>
    <phone>+358407422328</phone>
    <email>riitta.veijola@oulu.fi</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Oulu and Oulu University Hospital</name>
      <address>
        <city>Oulu</city>
        <zip>90029</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Riitta Veijola, MD</last_name>
      <phone>+358 8 3155129</phone>
      <email>riitta.veijola@oulu.fi</email>
    </contact>
    <investigator>
      <last_name>Riitta Veijola, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Tampere and Tampere University Hospital</name>
      <address>
        <city>Tampere</city>
        <zip>33520</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mikael Knip, MD</last_name>
      <email>mikael.knip@helsinki.fi</email>
    </contact>
    <investigator>
      <last_name>Mikael Knip, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Turku and Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jorma Toppari, MD</last_name>
      <email>jorma.toppari@utu.fi</email>
    </contact>
    <investigator>
      <last_name>Jorma Toppari, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Oulu</investigator_affiliation>
    <investigator_full_name>Riitta Veijola</investigator_full_name>
    <investigator_title>Professor of Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03269084
org study id: 1-SRA-2016-342-M-R
nct id: NCT03269084
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Type 1 Diabetes Prediction and Prevention (DIPP) Study in Finland is a population-based
      long-term clinical follow-up study established since 1994 in three university hospitals in
      Finland to understand the pathogenesis of type 1 diabetes (T1D), predict the disease, and
      find preventive treatment.
Briefly, cord blood samples are collected and HLA-DR-DQ genotypes are determined from newborn
      babies. Families with a newborn baby carrying a DR-DQ genotype associated with increased risk
      for T1D are invited to participate in regular follow-up at the age of 3, 6, 9, 12, 18 and 24
      months, and thereafter once a year until the age of 15 years or until T1D is diagnosed.
      Clinical details including maternal diet during pregnancy and lactation and child's diet
      starting from the age of 3 months are recorded, blood samples are collected, and serum
      autoantibodies associated with development of T1D are measured. Children who develop
      beta-cell specific autoimmunity are followed more intensively with measurements of glucose
      metabolism parameters such as glycated haemoglobin A1c (HbA1c), oral glucose tolerance tests
      (OGTT) and intravenous glucose tolerance tests (IVGTT). In the DIPP Study more than 1000
      children have developed multiple islet autoantibodies and more than 450 of these have
      progressed to clinical T1D. It has been estimated that 5% of children in the follow-up will
      develop T1D and 60% of future T1D cases will be reached by the current screening and
      follow-up strategy.
observational model: Cohort
time perspective: Prospective
measure: Positivity for at least one islet autoantibody
time frame: December 31, 2021
description: ICA, IAA, GADA, IA-2A or ZnT8A
measure: Clinical diagnosis of type 1 diabetes
time frame: December 31, 2021
description: Hyperglycemia as defined by WHO
arm group label: Children at HLA-conferred risk for T1D
intervention type: Other
intervention name: No intervention. DIPP is an observational study.
arm group label: Children at HLA-conferred risk for T1D
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Riitta Veijola, MD PhD
role: Principal Investigator
affiliation: University of Oulu, Oulu University Hospital
last name: Mikael Knip, MD PhD
role: Principal Investigator
affiliation: University of Helsinki, Tampere University Hospital
last name: Jorma Toppari, MD PhD
role: Principal Investigator
affiliation: University of Turku, Turku University Hospital
last name: Kalle Kurppa, MD PhD
role: Principal Investigator
affiliation: Tampere University
last name: Heikki Hyöty, MD PhD
role: Principal Investigator
affiliation: Tampere University
last name: Johanna Lempainen, MD PhD
role: Principal Investigator
affiliation: University of Turku
last name: Riitta Veijola, MD PhD
phone: +358407422328
email: riitta.veijola@oulu.fi
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Finland
responsible party type: Sponsor-Investigator
investigator affiliation: University of Oulu
investigator full name: Riitta Veijola
investigator title: Professor of Pediatrics
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: Undecided