<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/NCT03014908</url>
  </required_header>
  <id_info>
    <org_study_id>LCRP-obesitas</org_study_id>
    <nct_id>NCT03014908</nct_id>
  </id_info>
  <brief_title>Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents</brief_title>
  <acronym>T1DM</acronym>
  <official_title>Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents: a Case-control Study</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>
      The aim of this study was to look for discriminating variation in the concentrations of&#xD;
      small-molecule metabolites in the plasma of T1DM children compared with non-diabetic matched&#xD;
      controls using proton nuclear magnetic resonance (1H-NMR)-based metabolomics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type 1 diabetes mellitus (T1DM) is one of the most common pediatric diseases and its&#xD;
      incidence is rising in many countries. Recently, it has been shown that metabolites other&#xD;
      than glucose play an important role in insulin deficiency and the development of diabetes.&#xD;
      The aim of this study was to look for discriminating variation in the concentrations of&#xD;
      small-molecule metabolites in the plasma of T1DM children compared with non-diabetic matched&#xD;
      controls using proton nuclear magnetic resonance (1H-NMR)-based metabolomics.&#xD;
&#xD;
      This cross-sectional study was set-up to examine the metabolic profile in fasting plasma&#xD;
      samples from 7 T1DM children and 7 non-diabetic controls aged 8 to 18 years, and matched for&#xD;
      gender, age and BMI. The obtained plasma 1H-NMR spectra were rationally divided into 110&#xD;
      integration regions, representing the metabolic phenotype. These integration regions reflect&#xD;
      the relative metabolite concentrations and were used as statistical variables to construct&#xD;
      (train) a classification model in discriminating between T1DM patients and controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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 type 1 diabetes mellitus</measure>
    <time_frame>10 months</time_frame>
    <description>Significant metabolic changes in blood plasma of type 1 diabetic patients compared with control subjects</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">14</enrollment>
  <condition>Type1diabetes</condition>
  <arm_group>
    <arm_group_label>NMR-T1DM</arm_group_label>
    <description>type 1 diabetic children and adolescents</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NMR-C</arm_group_label>
    <description>non-diabetic 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>NMR-T1DM</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>
        from 7 T1DM children and 7 non-diabetic controls aged 8 to 18 years, and matched for&#xD;
        gender, age and BMI&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged between 8 and 18&#xD;
&#xD;
          -  normal-weight according to the International Obesity Task Force (IOTF) BMI criteria&#xD;
&#xD;
          -  fasted for at least 8 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lipid-lowering drugs or other medication&#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>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>Hasselt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Evelyne Louis, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hasselt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean-Paul Noben, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hasselt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Liene Bervoets, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hasselt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hasselt University</name>
      <address>
        <city>Hasselt</city>
        <state>Limburg</state>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <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>Brugnara L, Mallol R, Ribalta J, Vinaixa M, Murillo S, Casserras T, Guardiola M, Vallve JC, Kalko SG, Correig X, Novials A. Improving Assessment of Lipoprotein Profile in Type 1 Diabetes by 1H NMR Spectroscopy. PLoS One. 2015 Aug 28;10(8):e0136348. doi: 10.1371/journal.pone.0136348. eCollection 2015.</citation>
    <PMID>26317989</PMID>
  </reference>
  <reference>
    <citation>Lanza IR, Zhang S, Ward LE, Karakelides H, Raftery D, Nair KS. Quantitative metabolomics by H-NMR and LC-MS/MS confirms altered metabolic pathways in diabetes. PLoS One. 2010 May 10;5(5):e10538. doi: 10.1371/journal.pone.0010538.</citation>
    <PMID>20479934</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 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>Type 1 diabetes</keyword>
  <keyword>1H-NMR spectroscopy</keyword>
  <keyword>Metabolomics</keyword>
  <keyword>Pediatrics</keyword>
  <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>
  <!-- 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/NCT03014908
org study id: LCRP-obesitas
nct id: NCT03014908
lead sponsor: 
collaborator: 
The aim of this study was to look for discriminating variation in the concentrations of
      small-molecule metabolites in the plasma of T1DM children compared with non-diabetic matched
      controls using proton nuclear magnetic resonance (1H-NMR)-based metabolomics.
Type 1 diabetes mellitus (T1DM) is one of the most common pediatric diseases and its
      incidence is rising in many countries. Recently, it has been shown that metabolites other
      than glucose play an important role in insulin deficiency and the development of diabetes.
      The aim of this study was to look for discriminating variation in the concentrations of
      small-molecule metabolites in the plasma of T1DM children compared with non-diabetic matched
      controls using proton nuclear magnetic resonance (1H-NMR)-based metabolomics.

      This cross-sectional study was set-up to examine the metabolic profile in fasting plasma
      samples from 7 T1DM children and 7 non-diabetic controls aged 8 to 18 years, and matched for
      gender, age and BMI. 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
      (train) a classification model in discriminating between T1DM patients and controls.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Metabolic phenotype of type 1 diabetes mellitus
time frame: 10 months
description: Significant metabolic changes in blood plasma of type 1 diabetic patients compared with control subjects
arm group label: NMR-T1DM
description: type 1 diabetic children and adolescents
arm group label: NMR-C
description: non-diabetic 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: NMR-T1DM
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: Guy Massa, PhD, MD
role: Study Chair
affiliation: Jessa Ziekenhuis Hasselt
last name: Wanda Guedens, PhD
role: Study Chair
affiliation: Hasselt University
last name: Evelyne Louis, PhD
role: Study Chair
affiliation: Hasselt University
last name: Jean-Paul Noben, PhD
role: Study Chair
affiliation: Hasselt University
last name: Liene Bervoets, PhD
role: Study Chair
affiliation: Hasselt University
facility: 
country: Belgium
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: Brugnara L, Mallol R, Ribalta J, Vinaixa M, Murillo S, Casserras T, Guardiola M, Vallve JC, Kalko SG, Correig X, Novials A. Improving Assessment of Lipoprotein Profile in Type 1 Diabetes by 1H NMR Spectroscopy. PLoS One. 2015 Aug 28;10(8):e0136348. doi: 10.1371/journal.pone.0136348. eCollection 2015.
PMID: 26317989
citation: Lanza IR, Zhang S, Ward LE, Karakelides H, Raftery D, Nair KS. Quantitative metabolomics by H-NMR and LC-MS/MS confirms altered metabolic pathways in diabetes. PLoS One. 2010 May 10;5(5):e10538. doi: 10.1371/journal.pone.0010538.
PMID: 20479934
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: Peter Adriaensens
investigator title: professor (hoogleraar)
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1