<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/NCT03256006</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A02397-46</org_study_id>
    <nct_id>NCT03256006</nct_id>
  </id_info>
  <brief_title>Study Inflammation During a 100 Miles</brief_title>
  <acronym>TRAIL PHYSIO</acronym>
  <official_title>Per Effort Study of Inflammation During a 100 Miles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Necker-Enfants Malades</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital Necker-Enfants Malades</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study per and post effort variations of inflammatory biological markers during a 100 miles&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 18, 2018</start_date>
  <completion_date type="Anticipated">October 29, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 18, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Variation per and post effort of interleukin 1 plasma level</measure>
    <time_frame>Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race</time_frame>
    <description>Plasma level of per and post effort of interleukin 1 will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variation per and post effort of interleukin 6 plasma level</measure>
    <time_frame>Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race</time_frame>
    <description>Plasma level of per and post effort of interleukin 6 will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variation of per and post effort of protein C reactive</measure>
    <time_frame>Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race</time_frame>
    <description>Plasma level of per and post effort of protein C reactive will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variation per and post effort of interleukin Tumor Necrosis Factor alpha</measure>
    <time_frame>Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race</time_frame>
    <description>Plasma level of per and post effort of tumor necrosis alpha will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variation per and post effort of interleukin 4 plasma level</measure>
    <time_frame>Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race</time_frame>
    <description>Plasma level of per and post effort of interleukin 4 will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variation per and post effort of interleukin 10 plasma level</measure>
    <time_frame>Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race</time_frame>
    <description>Plasma level of per and post effort of interleukin 10 will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variation per and post effort of interleukin 13 plasma level</measure>
    <time_frame>Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race</time_frame>
    <description>Plasma level of per and post effort of interleukin 13 will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variation per and post effort of interleukin tumor growth factor beta plasma level</measure>
    <time_frame>Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race</time_frame>
    <description>Plasma level of per and post effort of tumor growth factor beta</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variation per and post effort of lipids plasma level</measure>
    <time_frame>Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race</time_frame>
    <description>Plasma level of per and post effort of lipids</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variation per and post effort of lipoproteins plasma level</measure>
    <time_frame>Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race</time_frame>
    <description>Plasma level of per and post effort of lipoproteins</description>
  </primary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Inflammatory Response</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>Blood sample to study per and post effort evolution markers of systemic inflammation</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      pro and anti inflammatory biomarkers (reactive oxygen species)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults (age&gt;18years)&#xD;
&#xD;
          -  completion of an ultra endurance race (50 miles) during the 2 years before&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  age&lt;18years&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 1, 2018</last_update_submitted>
  <last_update_submitted_qc>August 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Necker-Enfants Malades</investigator_affiliation>
    <investigator_full_name>Romain Jouffroy</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>sport exercise</keyword>
  <keyword>ultra endurance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03256006
org study id: 2017-A02397-46
nct id: NCT03256006
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To study per and post effort variations of inflammatory biological markers during a 100 miles
observational model: Cohort
time perspective: Prospective
measure: Variation per and post effort of interleukin 1 plasma level
time frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
description: Plasma level of per and post effort of interleukin 1 will be measured
measure: Variation per and post effort of interleukin 6 plasma level
time frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
description: Plasma level of per and post effort of interleukin 6 will be measured
measure: Variation of per and post effort of protein C reactive
time frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
description: Plasma level of per and post effort of protein C reactive will be measured
measure: Variation per and post effort of interleukin Tumor Necrosis Factor alpha
time frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
description: Plasma level of per and post effort of tumor necrosis alpha will be measured
measure: Variation per and post effort of interleukin 4 plasma level
time frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
description: Plasma level of per and post effort of interleukin 4 will be measured
measure: Variation per and post effort of interleukin 10 plasma level
time frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
description: Plasma level of per and post effort of interleukin 10 will be measured
measure: Variation per and post effort of interleukin 13 plasma level
time frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
description: Plasma level of per and post effort of interleukin 13 will be measured
measure: Variation per and post effort of interleukin tumor growth factor beta plasma level
time frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
description: Plasma level of per and post effort of tumor growth factor beta
measure: Variation per and post effort of lipids plasma level
time frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
description: Plasma level of per and post effort of lipids
measure: Variation per and post effort of lipoproteins plasma level
time frame: Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race
description: Plasma level of per and post effort of lipoproteins
intervention type: Other
intervention name: Blood sample
description: Blood sample to study per and post effort evolution markers of systemic inflammation
pro and anti inflammatory biomarkers (reactive oxygen species)
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Hôpital Necker-Enfants Malades
investigator full name: Romain Jouffroy
investigator title: Principal Investigator
mesh term: Inflammation
sharing ipd: Undecided