<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/NCT02977416</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0295</org_study_id>
    <secondary_id>2016-A01262-49</secondary_id>
    <nct_id>NCT02977416</nct_id>
  </id_info>
  <brief_title>Oxidation Rates of the Different Substrates During Exercise in Children and Adolescents With Juvenile Idiopathic Arthritis. Case-control Study and Cases Treated / Cases Not Treated With Anti-TNFα</brief_title>
  <acronym>OSE-JIA</acronym>
  <official_title>Oxidation Rates of the Different Substrates During Exercise in Children and Adolescents With Juvenile Idiopathic Arthritis. Case-control Study and Cases Treated / Cases Not Treated With Anti-TNFα</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      During exercise, energy comes mainly from carbohydrates and lipids. The relative contribution&#xD;
      of lipids and glucose as energy substrates to exercise depends on the parameters of the&#xD;
      exercise (duration, intensity and level of training) and the physiological conditions of the&#xD;
      subject.&#xD;
&#xD;
      Inflammatory diseases such as juvenile idiopathic arthritis (JIA) are treated, for the most&#xD;
      severe forms, by biotherapies. These treatments target certain pro-inflammatory cytokines&#xD;
      including TNFα. In adults with rheumatoid arthritis several studies have shown that treatment&#xD;
      with anti-TNFα increases insulin sensitivity. There is no data on the oxidation of energy&#xD;
      substrates during exercise in children and adolescents with AJI, nor on the impact of&#xD;
      anti-TNFα treatments on the oxidation of energetic substrates in children.&#xD;
&#xD;
      Investigators hypothesize that, compared to healthy children, children with JIA should&#xD;
      exhibit altered oxidation of energy substrates at rest and submaximal physical exercise due&#xD;
      to physical deconditioning and inflammation. In addition, those treated with anti-TNFα should&#xD;
      have an oxidation profile of energy substrates at exercise different from that of patients&#xD;
      not treated with anti-TNFα. Investigators also hypothesize that anti-TNFα treatments modify&#xD;
      the contribution of energy chains (aerobic, anaerobic and anaerobic alactic) during the&#xD;
      exercise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Annual evaluation by Lipoxmax test and Wingate anaerobic test (WAnT) during 3 years or until&#xD;
      the transition from pediatric to adult care.&#xD;
&#xD;
      For healthy volunteer, only one lipaxmax and Wingate test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">May 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage variation of the maximal fat oxidative rate during an exercise between JIA and healthy children. Timing:</measure>
    <time_frame>at day 1 (first test)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage variation of substrates oxidative crossing point during an exercise.</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the contribution of energy systems during supra-maximal physical exercise</measure>
    <time_frame>at day 1 (first test)</time_frame>
    <description>Description of the contribution of energy systems during supra-maximal physical exercise in patients with JIA according to JIA subtype, treatments, age, pubertal status, disease status</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <arm_group>
    <arm_group_label>patients treated withTNF blockade</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>22 patients treated with TNF blockade</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients without TNF blockade</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>22 patients without TNF blockade</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>22 matched healthy subjects by pubertal stage and sex</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>anti-TNFα</intervention_name>
    <arm_group_label>healthy subjects</arm_group_label>
    <arm_group_label>patients treated withTNF blockade</arm_group_label>
    <arm_group_label>patients without TNF blockade</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with juvenile idiopathic arthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active infection&#xD;
&#xD;
          -  BMI &gt; 25&#xD;
&#xD;
          -  Systemic corticosteroid within last 3 months&#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>Etienne MERLIN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick LACARIN</last_name>
    <phone>04 73 75 11 95</phone>
    <email>placarin@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Clermon-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick LACARIN</last_name>
      <phone>0473751195</phone>
      <email>placarin@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Etienne MERLIN</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Juvenile idiopathic arthritis</keyword>
  <keyword>fat oxidation</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Juvenile</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/NCT02977416
org study id: CHU-0295
secondary id: 2016-A01262-49
nct id: NCT02977416
lead sponsor: 
During exercise, energy comes mainly from carbohydrates and lipids. The relative contribution
      of lipids and glucose as energy substrates to exercise depends on the parameters of the
      exercise (duration, intensity and level of training) and the physiological conditions of the
      subject.

      Inflammatory diseases such as juvenile idiopathic arthritis (JIA) are treated, for the most
      severe forms, by biotherapies. These treatments target certain pro-inflammatory cytokines
      including TNFα. In adults with rheumatoid arthritis several studies have shown that treatment
      with anti-TNFα increases insulin sensitivity. There is no data on the oxidation of energy
      substrates during exercise in children and adolescents with AJI, nor on the impact of
      anti-TNFα treatments on the oxidation of energetic substrates in children.

      Investigators hypothesize that, compared to healthy children, children with JIA should
      exhibit altered oxidation of energy substrates at rest and submaximal physical exercise due
      to physical deconditioning and inflammation. In addition, those treated with anti-TNFα should
      have an oxidation profile of energy substrates at exercise different from that of patients
      not treated with anti-TNFα. Investigators also hypothesize that anti-TNFα treatments modify
      the contribution of energy chains (aerobic, anaerobic and anaerobic alactic) during the
      exercise.
Annual evaluation by Lipoxmax test and Wingate anaerobic test (WAnT) during 3 years or until
      the transition from pediatric to adult care.

      For healthy volunteer, only one lipaxmax and Wingate test.
allocation: Non-Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Percentage variation of the maximal fat oxidative rate during an exercise between JIA and healthy children. Timing:
time frame: at day 1 (first test)
measure: Percentage variation of substrates oxidative crossing point during an exercise.
time frame: at day 1
measure: Description of the contribution of energy systems during supra-maximal physical exercise
time frame: at day 1 (first test)
description: Description of the contribution of energy systems during supra-maximal physical exercise in patients with JIA according to JIA subtype, treatments, age, pubertal status, disease status
arm group label: patients treated withTNF blockade
arm group type: Experimental
description: 22 patients treated with TNF blockade
arm group label: patients without TNF blockade
arm group type: Experimental
description: 22 patients without TNF blockade
arm group label: healthy subjects
arm group type: Experimental
description: 22 matched healthy subjects by pubertal stage and sex
intervention type: Other
intervention name: anti-TNFα
arm group label: healthy subjects
arm group label: patients treated withTNF blockade
arm group label: patients without TNF blockade
criteria: 
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Etienne MERLIN
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Patrick LACARIN
phone: 04 73 75 11 95
email: placarin@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Juvenile