<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/NCT03305198</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A01147-46</org_study_id>
    <nct_id>NCT03305198</nct_id>
  </id_info>
  <brief_title>BIOlogical Response to Exercise : A Metabolomic Study in Peripheral Artery Disease (BIOR)</brief_title>
  <acronym>BIOR</acronym>
  <official_title>BIOlogical Response to Exercise : A Metabolomic Study in Peripheral Artery Disease (BIOR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</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>
      The measurement of the transcutaneous oxygen pressure during walking allows to estimate the&#xD;
      importance of ischemia, bilaterally and segment of limb by segment of limb. The determination&#xD;
      of the metabolic compounds concentration, with metabolomic approach, is emerging in&#xD;
      physiology and exercise.&#xD;
&#xD;
      This pilot study focuses on the feasibility of the metabolomics analysis with micro method ,&#xD;
      by capillary drawing from earlobe sampling, for patients with peripheral artery disease (PAD)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ankle brachial index is measured at rest for alml subjects. Blood sample (180-360 microliter)&#xD;
      will be collected at rest transcutaneous oxygen pressure is measured at the chest, calves and&#xD;
      buttocks and results will be expressed as the minimal value of the DROP index (Limb changes&#xD;
      minus chest changes) Patients walk on treadmill (2MPH 10% slope) until exertional limb pain.&#xD;
      Blood sample (180 microliter) will be collected again, at minute 3 of recovery from walking&#xD;
      Correlation of each metobolite increase to the sum of DROP values wil be studied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">March 18, 2019</completion_date>
  <primary_completion_date type="Actual">March 18, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Analysis of changes in metabolomic signature from rest to post exercise</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Metabolomic analysis will be performed blinded to the exercise test results</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Chances in the metabolomic signature of arterial claudication by capillary blood sampling from the earlobe</measure>
    <time_frame>Half an hour (includes the resting walking and recovery period of exercise)</time_frame>
    <description>Search a significant difference between biological markers before and after the test during a walk on a treadmill</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes inthe correlation of observed metabolomic variations and the importance of ischemia evaluated by oximetry</measure>
    <time_frame>Half an hour (includes the resting walking and recovery period of exercise)</time_frame>
    <description>Evaluate the coefficient of correlation between the changes of metabolomic pârameters and the sum of the observed DROPmin values of all studied subjects.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Peripheral Artery Disease</condition>
  <arm_group>
    <arm_group_label>Patients undergoing exercise oximetry</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with PAD referred for treadmill testing and exercise oximetry will have a capillary blood sampling from the earlobe</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Capillary blood sampling from the earlobe</intervention_name>
    <description>Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period</description>
    <arm_group_label>Patients undergoing exercise oximetry</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  Patient able to walk on a treadmill&#xD;
&#xD;
          -  Patient agrees to be involve in the protocol and sign the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient not covered by the French health insurance&#xD;
&#xD;
          -  Patient has a wash-out period for another clinical trial&#xD;
&#xD;
          -  Patient with comorbidity as bleeding disorder or with a anticoagulant therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre ABRAHAM, MD, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital in Angers</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre hospitalier universitaire</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</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/NCT03305198
org study id: 2017-A01147-46
nct id: NCT03305198
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The measurement of the transcutaneous oxygen pressure during walking allows to estimate the
      importance of ischemia, bilaterally and segment of limb by segment of limb. The determination
      of the metabolic compounds concentration, with metabolomic approach, is emerging in
      physiology and exercise.

      This pilot study focuses on the feasibility of the metabolomics analysis with micro method ,
      by capillary drawing from earlobe sampling, for patients with peripheral artery disease (PAD)
Ankle brachial index is measured at rest for alml subjects. Blood sample (180-360 microliter)
      will be collected at rest transcutaneous oxygen pressure is measured at the chest, calves and
      buttocks and results will be expressed as the minimal value of the DROP index (Limb changes
      minus chest changes) Patients walk on treadmill (2MPH 10% slope) until exertional limb pain.
      Blood sample (180 microliter) will be collected again, at minute 3 of recovery from walking
      Correlation of each metobolite increase to the sum of DROP values wil be studied.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Analysis of changes in metabolomic signature from rest to post exercise
primary purpose: Basic Science
masking: None (Open Label)
masking description: Metabolomic analysis will be performed blinded to the exercise test results
measure: Chances in the metabolomic signature of arterial claudication by capillary blood sampling from the earlobe
time frame: Half an hour (includes the resting walking and recovery period of exercise)
description: Search a significant difference between biological markers before and after the test during a walk on a treadmill
measure: Changes inthe correlation of observed metabolomic variations and the importance of ischemia evaluated by oximetry
time frame: Half an hour (includes the resting walking and recovery period of exercise)
description: Evaluate the coefficient of correlation between the changes of metabolomic pârameters and the sum of the observed DROPmin values of all studied subjects.
arm group label: Patients undergoing exercise oximetry
arm group type: Experimental
description: Patients with PAD referred for treadmill testing and exercise oximetry will have a capillary blood sampling from the earlobe
intervention type: Biological
intervention name: Capillary blood sampling from the earlobe
description: Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period
arm group label: Patients undergoing exercise oximetry
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre ABRAHAM, MD, Ph.D
role: Principal Investigator
affiliation: University Hospital in Angers
facility: 
country: France
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
sharing ipd: Undecided