<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/NCT02208141</url>
  </required_header>
  <id_info>
    <org_study_id>IFB ADI K7-10</org_study_id>
    <nct_id>NCT02208141</nct_id>
  </id_info>
  <brief_title>Leipzig Adipose Tissue Childhood Cohort</brief_title>
  <official_title>Determinants of Adipose Tissue Development and Obesity in 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>
      In this study the investigators hypothesize that pathological alterations in adipose tissue&#xD;
      biology already occur during the development and progression of obesity in children and&#xD;
      adolescents. The investigators aim to identify and characterize mechanisms and molecular&#xD;
      targets that affect the development of adipose tissue and ensuing obesity in childhood and&#xD;
      adolescence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aim to identify how adipose tissue dysfunction in childhood contributes to&#xD;
      the development of obesity and related comorbidities and to characterize factors that play a&#xD;
      role in the development of adipose dysfunction in children. The investigators will employ a&#xD;
      translational approach which is based on the characterization of adipose tissue biology in&#xD;
      samples of children to determine alterations leading to adipose tissue dysfunction. These&#xD;
      include assessment of the composition (including BAT), remodeling, function, metabolism and&#xD;
      inflammation of adipose tissue as well as the adipokine profile. For the assessment of&#xD;
      clinical relevance, these experimental data will then be correlated with the clinical&#xD;
      phenotype. Finally, we aim to identify factors responsible for early adipose tissue&#xD;
      dysfunction and characterize them for their clinical and functional relevance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2010</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 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>Adipose tissue dysfunction</measure>
    <time_frame>10 years</time_frame>
    <description>Adipose tissue dysfunction is assessed by evaluation of adipocyte size and number (hypertrophy vs. hyperplasia), adipocyte proliferation and differentiation, (lipid) cellular metabolism, inflammation, gene expression, fibrosis, and others; the association of AT dysfunction with clincial phenotype will be assessed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of brown adipose tissue (BAT)</measure>
    <time_frame>10 years</time_frame>
    <description>Adipose tissue samples will be evaluated for the presence of BAT on histological and molecular level and association with clinical phenotype will be investigated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation of adipose tissue</measure>
    <time_frame>10 years</time_frame>
    <description>Inflammation will be assessed by evaluating macrophage infiltration on histological and molecular expression level. Also, association with clinical phenotype will be assessed.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Childhood Obesity</condition>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>lean and obese children and adolescents</arm_group_label>
    <description>study cohort may be stratified for lean (definded as BMI &lt;1.28 SDS) and overweight/obese (definded as BMI&gt;= 1.28 SDS) children for posthoc analyses no intervention</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  adipose tissue sample&#xD;
&#xD;
        -  mRNA from adipose tissue samples, adipocytes, stromal vascular fraction&#xD;
&#xD;
        -  protein from whole adipose tissue samples&#xD;
&#xD;
        -  blood samples for DNA analysis, serum samples&#xD;
&#xD;
        -  urine samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        children and adolescents undergoing surgery at the University Hospital Leipzig&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  body weight: 3000 g - 180 kg&#xD;
&#xD;
          -  suitable surgical procedure&#xD;
&#xD;
          -  signed informed consent by the guardians and the study participant, if older 12 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe chronic and inflammatory diseases&#xD;
&#xD;
          -  acute or chronic infections&#xD;
&#xD;
          -  oncological diseases&#xD;
&#xD;
          -  clotting disorders&#xD;
&#xD;
          -  complications during surgical procedure&#xD;
&#xD;
          -  drug treatment&#xD;
&#xD;
          -  nil by mouth&#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>Antje Körner, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leipzig</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Antje Körner, Prof. Dr.</last_name>
    <phone>0049/(0)341-9726854</phone>
    <email>Antje.Koerner@medizin.uni-leipzig.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Robert Stein, MD</last_name>
    <phone>0049/(0)341-9726537</phone>
    <email>Robert.stein@medizin.uni-leipzig.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Center for Pediatric Research Leipzig (CPL)</name>
      <address>
        <city>Leipzig</city>
        <state>Sachsen</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antje Körner, Prof. Dr.</last_name>
      <phone>0049/(0)341-9726854</phone>
      <email>Antje.Koerner@medizin.uni-leipzig.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://kik.uniklinikum-leipzig.de/kikcms.site,postext,childhood-obesity-antje-koerner,a_id,1062.html</url>
    <description>Link to Prof. Dr. med. Antje Körner's research group: &quot;childhood obesity&quot;</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/</url>
    <description>Link to University Children's Hospital Leipzig</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</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 28, 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>children</keyword>
  <keyword>obesity</keyword>
  <keyword>adipose tissue dysfunction</keyword>
  <keyword>inflammation</keyword>
  <keyword>macrophage infiltration</keyword>
  <keyword>insulin resistance</keyword>
  <keyword>dyslipidemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Insulin Resistance</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/NCT02208141
org study id: IFB ADI K7-10
nct id: NCT02208141
lead sponsor: 
has dmc: No
In this study the investigators hypothesize that pathological alterations in adipose tissue
      biology already occur during the development and progression of obesity in children and
      adolescents. The investigators aim to identify and characterize mechanisms and molecular
      targets that affect the development of adipose tissue and ensuing obesity in childhood and
      adolescence.
The investigators aim to identify how adipose tissue dysfunction in childhood contributes to
      the development of obesity and related comorbidities and to characterize factors that play a
      role in the development of adipose dysfunction in children. The investigators will employ a
      translational approach which is based on the characterization of adipose tissue biology in
      samples of children to determine alterations leading to adipose tissue dysfunction. These
      include assessment of the composition (including BAT), remodeling, function, metabolism and
      inflammation of adipose tissue as well as the adipokine profile. For the assessment of
      clinical relevance, these experimental data will then be correlated with the clinical
      phenotype. Finally, we aim to identify factors responsible for early adipose tissue
      dysfunction and characterize them for their clinical and functional relevance.
observational model: Cohort
time perspective: Cross-Sectional
measure: Adipose tissue dysfunction
time frame: 10 years
description: Adipose tissue dysfunction is assessed by evaluation of adipocyte size and number (hypertrophy vs. hyperplasia), adipocyte proliferation and differentiation, (lipid) cellular metabolism, inflammation, gene expression, fibrosis, and others; the association of AT dysfunction with clincial phenotype will be assessed
measure: Presence of brown adipose tissue (BAT)
time frame: 10 years
description: Adipose tissue samples will be evaluated for the presence of BAT on histological and molecular level and association with clinical phenotype will be investigated
measure: Inflammation of adipose tissue
time frame: 10 years
description: Inflammation will be assessed by evaluating macrophage infiltration on histological and molecular expression level. Also, association with clinical phenotype will be assessed.
arm group label: lean and obese children and adolescents
description: study cohort may be stratified for lean (definded as BMI <1.28 SDS) and overweight/obese (definded as BMI>= 1.28 SDS) children for posthoc analyses no intervention
-  adipose tissue sample

        -  mRNA from adipose tissue samples, adipocytes, stromal vascular fraction

        -  protein from whole adipose tissue samples

        -  blood samples for DNA analysis, serum samples

        -  urine samples
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: Antje Körner, Prof. Dr.
role: Principal Investigator
affiliation: University of Leipzig
last name: Antje Körner, Prof. Dr.
phone: 0049/(0)341-9726854
email: Antje.Koerner@medizin.uni-leipzig.de
last name: Robert Stein, MD
phone: 0049/(0)341-9726537
email: Robert.stein@medizin.uni-leipzig.de
facility: 
status: Recruiting
contact: 
country: Germany
url: http://kik.uniklinikum-leipzig.de/kikcms.site,postext,childhood-obesity-antje-koerner,a_id,1062.html
description: Link to Prof. Dr. med. Antje Körner's research group: "childhood obesity"
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/
description: Link to University Children's Hospital Leipzig
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: Obesity
mesh term: Insulin Resistance
mesh term: Pediatric Obesity