<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/NCT03014856</url>
  </required_header>
  <id_info>
    <org_study_id>LCRP-OBNMR</org_study_id>
    <nct_id>NCT03014856</nct_id>
  </id_info>
  <brief_title>Metabolic Phenotypes in Childhood Obesity</brief_title>
  <official_title>Identification of Metabolic Phenotypes in Childhood Obesity by 1H-NMR Metabolomics of Blood Plasma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hasselt University</source>
  <brief_summary>
    <textblock>
      This study provides a sound basis towards a better understanding of the biochemical&#xD;
      mechanisms behind childhood obesity and its metabolic phenotypes, which will be of great&#xD;
      importance towards the development of more personalized prevention and treatment in future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study was to identify the plasma metabolic profile associated with childhood&#xD;
      obesity and its phenotypes..&#xD;
&#xD;
      This cross-sectional study was set-up to examine the metabolic profile in fasting plasma&#xD;
      samples from 65 overweight and obese (OB) children and 37 normal-weight (NW) controls aged 8&#xD;
      to 18 years. The obtained plasma 1H-NMR spectra were rationally divided into 110 integration&#xD;
      regions, representing the metabolic phenotype. These integration regions reflect the relative&#xD;
      metabolite concentrations and were used as statistical variables to construct a&#xD;
      classification model in discriminating between OB and NW children and adolescents. In&#xD;
      addition, two metabolic phenotypes were defined within the OB group, i.e. the metabolically&#xD;
      &quot;healthy&quot; obese (MHO) and metabolically unhealthy obese (MUO) phenotype which are both&#xD;
      classified as obese but with respectively, none (MHO) or at least two components (MUO) of the&#xD;
      metabolic syndrome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>metabolic phenotype of childhood obesity</measure>
    <time_frame>day 1</time_frame>
    <description>Significant metabolic changes in blood plasma of obese children and adolescents and normal-weight control subjects</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>metabolic phenotype of metabolically healthy and unhealthy obese children and adolescents</measure>
    <time_frame>day 1</time_frame>
    <description>Significant metabolic changes in blood plasma of metabolically healthy obese and metabolically unhealthy obese children and adolescents</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">102</enrollment>
  <condition>Obesity, Pediatric</condition>
  <arm_group>
    <arm_group_label>OB-NMR</arm_group_label>
    <description>overweight and obese children and adolescents</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NMR-C</arm_group_label>
    <description>normal-weight children and adolescents</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy</description>
    <arm_group_label>NMR-C</arm_group_label>
    <arm_group_label>OB-NMR</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood plasma for proton-NMR spectroscopy&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        65 overweight and obese (OB) children and 37 normal-weight (NW) controls aged 8 to 18 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 8 to 18&#xD;
&#xD;
          -  normal-weight, overweight or obese according to the International Obesity Task Force&#xD;
             (IOTF) Body Mass Index (BMI) criteria&#xD;
&#xD;
          -  fasted for at least 8 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects taking any medication or having serious chronic or acute illness within two&#xD;
             weeks preceding the clinical examination,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Adriaensens, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Material Research, Hasselt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Liene Bervoets, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hasselt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guy Massa, PhD, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Jessa Ziekenhuis Hasselt</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wanda Guedens, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Institute of Material Research, Hasselt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gunter Reekmans, Ing</last_name>
    <role>Study Chair</role>
    <affiliation>Institute of Material Research, Hasselt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean-Paul Noben, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>BIOMED, Hasselt University</affiliation>
  </overall_official>
  <reference>
    <citation>Beckonert O, Keun HC, Ebbels TM, Bundy J, Holmes E, Lindon JC, Nicholson JK. Metabolic profiling, metabolomic and metabonomic procedures for NMR spectroscopy of urine, plasma, serum and tissue extracts. Nat Protoc. 2007;2(11):2692-703. doi: 10.1038/nprot.2007.376.</citation>
    <PMID>18007604</PMID>
  </reference>
  <reference>
    <citation>Prince RL, Kuk JL, Ambler KA, Dhaliwal J, Ball GD. Predictors of metabolically healthy obesity in children. Diabetes Care. 2014 May;37(5):1462-8. doi: 10.2337/dc13-1697. Epub 2014 Feb 26.</citation>
    <PMID>24574347</PMID>
  </reference>
  <reference>
    <citation>Butte NF, Liu Y, Zakeri IF, Mohney RP, Mehta N, Voruganti VS, Goring H, Cole SA, Comuzzie AG. Global metabolomic profiling targeting childhood obesity in the Hispanic population. Am J Clin Nutr. 2015 Aug;102(2):256-67. doi: 10.3945/ajcn.115.111872. Epub 2015 Jun 17.</citation>
    <PMID>26085512</PMID>
  </reference>
  <reference>
    <citation>Perng W, Gillman MW, Fleisch AF, Michalek RD, Watkins SM, Isganaitis E, Patti ME, Oken E. Metabolomic profiles and childhood obesity. Obesity (Silver Spring). 2014 Dec;22(12):2570-8. doi: 10.1002/oby.20901. Epub 2014 Sep 24.</citation>
    <PMID>25251340</PMID>
  </reference>
  <reference>
    <citation>Mihalik SJ, Michaliszyn SF, de las Heras J, Bacha F, Lee S, Chace DH, DeJesus VR, Vockley J, Arslanian SA. Metabolomic profiling of fatty acid and amino acid metabolism in youth with obesity and type 2 diabetes: evidence for enhanced mitochondrial oxidation. Diabetes Care. 2012 Mar;35(3):605-11. doi: 10.2337/DC11-1577. Epub 2012 Jan 20.</citation>
    <PMID>22266733</PMID>
  </reference>
  <reference>
    <citation>Wahl S, Yu Z, Kleber M, Singmann P, Holzapfel C, He Y, Mittelstrass K, Polonikov A, Prehn C, Romisch-Margl W, Adamski J, Suhre K, Grallert H, Illig T, Wang-Sattler R, Reinehr T. Childhood obesity is associated with changes in the serum metabolite profile. Obes Facts. 2012;5(5):660-70. doi: 10.1159/000343204. Epub 2012 Oct 4.</citation>
    <PMID>23108202</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>Peter Adriaensens</investigator_full_name>
    <investigator_title>Professor (hoogleraar)</investigator_title>
  </responsible_party>
  <keyword>Metabolic syndrome</keyword>
  <keyword>Metabolomics</keyword>
  <keyword>NMR spectroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT03014856
org study id: LCRP-OBNMR
nct id: NCT03014856
lead sponsor: 
collaborator: 
This study provides a sound basis towards a better understanding of the biochemical
      mechanisms behind childhood obesity and its metabolic phenotypes, which will be of great
      importance towards the development of more personalized prevention and treatment in future.
The aim of this study was to identify the plasma metabolic profile associated with childhood
      obesity and its phenotypes..

      This cross-sectional study was set-up to examine the metabolic profile in fasting plasma
      samples from 65 overweight and obese (OB) children and 37 normal-weight (NW) controls aged 8
      to 18 years. The obtained plasma 1H-NMR spectra were rationally divided into 110 integration
      regions, representing the metabolic phenotype. These integration regions reflect the relative
      metabolite concentrations and were used as statistical variables to construct a
      classification model in discriminating between OB and NW children and adolescents. In
      addition, two metabolic phenotypes were defined within the OB group, i.e. the metabolically
      "healthy" obese (MHO) and metabolically unhealthy obese (MUO) phenotype which are both
      classified as obese but with respectively, none (MHO) or at least two components (MUO) of the
      metabolic syndrome.
observational model: Case-Control
time perspective: Cross-Sectional
measure: metabolic phenotype of childhood obesity
time frame: day 1
description: Significant metabolic changes in blood plasma of obese children and adolescents and normal-weight control subjects
measure: metabolic phenotype of metabolically healthy and unhealthy obese children and adolescents
time frame: day 1
description: Significant metabolic changes in blood plasma of metabolically healthy obese and metabolically unhealthy obese children and adolescents
arm group label: OB-NMR
description: overweight and obese children and adolescents
arm group label: NMR-C
description: normal-weight children and adolescents
intervention type: Other
intervention name: Blood sampling
description: Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy
arm group label: NMR-C
arm group label: OB-NMR
Blood plasma for proton-NMR spectroscopy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Adriaensens, PhD
role: Principal Investigator
affiliation: Institute of Material Research, Hasselt University
last name: Liene Bervoets, PhD
role: Study Chair
affiliation: Hasselt University
last name: Guy Massa, PhD, MD
role: Study Chair
affiliation: Jessa Ziekenhuis Hasselt
last name: Wanda Guedens, PhD
role: Study Chair
affiliation: Institute of Material Research, Hasselt University
last name: Gunter Reekmans, Ing
role: Study Chair
affiliation: Institute of Material Research, Hasselt University
last name: Jean-Paul Noben, PhD
role: Study Chair
affiliation: BIOMED, Hasselt University
citation: Beckonert O, Keun HC, Ebbels TM, Bundy J, Holmes E, Lindon JC, Nicholson JK. Metabolic profiling, metabolomic and metabonomic procedures for NMR spectroscopy of urine, plasma, serum and tissue extracts. Nat Protoc. 2007;2(11):2692-703. doi: 10.1038/nprot.2007.376.
PMID: 18007604
citation: Prince RL, Kuk JL, Ambler KA, Dhaliwal J, Ball GD. Predictors of metabolically healthy obesity in children. Diabetes Care. 2014 May;37(5):1462-8. doi: 10.2337/dc13-1697. Epub 2014 Feb 26.
PMID: 24574347
citation: Butte NF, Liu Y, Zakeri IF, Mohney RP, Mehta N, Voruganti VS, Goring H, Cole SA, Comuzzie AG. Global metabolomic profiling targeting childhood obesity in the Hispanic population. Am J Clin Nutr. 2015 Aug;102(2):256-67. doi: 10.3945/ajcn.115.111872. Epub 2015 Jun 17.
PMID: 26085512
citation: Perng W, Gillman MW, Fleisch AF, Michalek RD, Watkins SM, Isganaitis E, Patti ME, Oken E. Metabolomic profiles and childhood obesity. Obesity (Silver Spring). 2014 Dec;22(12):2570-8. doi: 10.1002/oby.20901. Epub 2014 Sep 24.
PMID: 25251340
citation: Mihalik SJ, Michaliszyn SF, de las Heras J, Bacha F, Lee S, Chace DH, DeJesus VR, Vockley J, Arslanian SA. Metabolomic profiling of fatty acid and amino acid metabolism in youth with obesity and type 2 diabetes: evidence for enhanced mitochondrial oxidation. Diabetes Care. 2012 Mar;35(3):605-11. doi: 10.2337/DC11-1577. Epub 2012 Jan 20.
PMID: 22266733
citation: Wahl S, Yu Z, Kleber M, Singmann P, Holzapfel C, He Y, Mittelstrass K, Polonikov A, Prehn C, Romisch-Margl W, Adamski J, Suhre K, Grallert H, Illig T, Wang-Sattler R, Reinehr T. Childhood obesity is associated with changes in the serum metabolite profile. Obes Facts. 2012;5(5):660-70. doi: 10.1159/000343204. Epub 2012 Oct 4.
PMID: 23108202
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: Peter Adriaensens
investigator title: Professor (hoogleraar)
mesh term: Obesity
mesh term: Pediatric Obesity