<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/NCT04491344</url>
  </required_header>
  <id_info>
    <org_study_id>ADI cohort Leipzig</org_study_id>
    <nct_id>NCT04491344</nct_id>
  </id_info>
  <brief_title>Geno- and Phenotyping of Overweight and Obese Children and Adolescents</brief_title>
  <official_title>Extended Geno- and Phenotyping of Overweight and Obese Children and Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leipzig</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Leipzig</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to identify polymorphisms that make children and adolescents more&#xD;
      prone to obesity and metabolic dysfunction, as well as to identify biomarkers that are linked&#xD;
      to causes and consequences of obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to identify single nucleotide polymorphisms blood and serum samples during oral&#xD;
      glucose tolerance testing are routinely obtained from pediatric patients visiting the&#xD;
      adiposity outpatient clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2002</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2022</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Gene-dependent association with phenotypical traits in overweight and obese children</measure>
    <time_frame>20 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>Overweight and obese children</arm_group_label>
    <description>Overweight and obese children and adolescents visiting the adiposity outpatient clinic.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  serum samples from oral glucose tolerance testing&#xD;
&#xD;
        -  blood samples for DNA analysis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Overweight and obese children and adolescents&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all pediatric patients seen in the adiposity outpatient clinic&#xD;
&#xD;
          -  informed patient consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antje Körner, Prof, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leipzig</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Antje Körner, Prof, MD</last_name>
    <phone>+49 341 97-26500</phone>
    <email>Antje.Koerner@medizin.uni-leipzig.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Robert Stein, MD</last_name>
    <phone>+49 341 97-26537</phone>
    <email>robert.stein@medizin.uni-leipzig.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Leipzig Medical Center, Department of Women and Child Health, Center for Pediatric Research Leipzig</name>
      <address>
        <city>Leipzig</city>
        <state>Saxony</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antje Körner, Prof, MD</last_name>
      <phone>+49 341 97-26500</phone>
      <email>Antje.Koerner@medizin.uni-leipzig.de</email>
    </contact>
    <contact_backup>
      <last_name>Julian Schwartze</last_name>
      <phone>+49 341 97-26537</phone>
      <email>JulianTristan.Schwartze@medizin.uni-leipzig.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://kik.uniklinikum-leipzig.de/kikcms.site,postext,ambulante-betreuung,a_id,262.html?PHPSESSID=t7ag2skgnd7cdc2dng21vh2u26</url>
    <description>Link to the pediatric adiposity outpatient clinic</description>
  </link>
  <link>
    <url>http://www.ifb-adipositas.de/en</url>
    <description>Link to &quot;Integrated Research and Treatment Center (IFB) Adiposity Diseases, Leipzig&quot;</description>
  </link>
  <link>
    <url>http://kik.uniklinikum-leipzig.de/kikcms.site,postext,childhood-obesity-antje-koerner.html?PHPSESSID=oakfosqa62ik082hs9bo6hsah3</url>
    <description>Link to Prof Antje Körner's Group</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leipzig</investigator_affiliation>
    <investigator_full_name>Antje Koerner, Prof. Dr. med.</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <keyword>Single nucleotide polymorphisms</keyword>
  <keyword>Obesity</keyword>
  <keyword>Insulin resistance</keyword>
  <keyword>Metabolic syndrome</keyword>
  <keyword>Oral glucose tolerance test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Pediatric Obesity</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/NCT04491344
org study id: ADI cohort Leipzig
nct id: NCT04491344
lead sponsor: 
has dmc: No
The aim of this study is to identify polymorphisms that make children and adolescents more
      prone to obesity and metabolic dysfunction, as well as to identify biomarkers that are linked
      to causes and consequences of obesity.
In order to identify single nucleotide polymorphisms blood and serum samples during oral
      glucose tolerance testing are routinely obtained from pediatric patients visiting the
      adiposity outpatient clinic.
observational model: Cohort
time perspective: Cross-Sectional
measure: Gene-dependent association with phenotypical traits in overweight and obese children
time frame: 20 years
arm group label: Overweight and obese children
description: Overweight and obese children and adolescents visiting the adiposity outpatient clinic.
-  serum samples from oral glucose tolerance testing

        -  blood samples for DNA analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Antje Körner, Prof, MD
role: Principal Investigator
affiliation: University of Leipzig
last name: Antje Körner, Prof, MD
phone: +49 341 97-26500
email: Antje.Koerner@medizin.uni-leipzig.de
last name: Robert Stein, MD
phone: +49 341 97-26537
email: robert.stein@medizin.uni-leipzig.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
url: http://kik.uniklinikum-leipzig.de/kikcms.site,postext,ambulante-betreuung,a_id,262.html?PHPSESSID=t7ag2skgnd7cdc2dng21vh2u26
description: Link to the pediatric adiposity outpatient clinic
url: http://www.ifb-adipositas.de/en
description: Link to "Integrated Research and Treatment Center (IFB) Adiposity Diseases, Leipzig"
url: http://kik.uniklinikum-leipzig.de/kikcms.site,postext,childhood-obesity-antje-koerner.html?PHPSESSID=oakfosqa62ik082hs9bo6hsah3
description: Link to Prof Antje Körner's Group
responsible party type: Principal Investigator
investigator affiliation: University of Leipzig
investigator full name: Antje Koerner, Prof. Dr. med.
investigator title: Prof. Dr. med.
mesh term: Overweight
mesh term: Pediatric Obesity