<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/NCT03036644</url>
  </required_header>
  <id_info>
    <org_study_id>P2017/028 / B406201630672</org_study_id>
    <nct_id>NCT03036644</nct_id>
  </id_info>
  <brief_title>Comparison of Electronic Cigarettes and Tobacco Cigarettes on Cardiovascular Function and Oxidative Stress</brief_title>
  <official_title>Effects of Electronic Cigarette Vaporization at High Temperature in Comparison to Tobacco Smoking on Cardiovascular Function and Oxidative Stress in Electronic Cigarette Users and Regular Tobacco Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université Libre de Bruxelles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université Libre de Bruxelles</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Background: Electronic cigarettes (e-cigarettes) are battery-powered devices heating a liquid&#xD;
      (e-liquid) composed of propylene glycol and/or vegetable glycerin, and most commonly,&#xD;
      nicotine to form an aerosol (vapor) that is inhaled (i.e. &quot;vaped&quot;). Scarce and conflicting&#xD;
      data are available regarding the cardiovascular toxicity of e-cigarettes. We wish to&#xD;
      determine the acute effects of propylene glycol/vegetable glycerin and nicotine vaporization&#xD;
      at high temperature in comparison to tobacco cigarette smoking on several advanced&#xD;
      cardiovascular parameters in healthy chronic e-cigarettes users and tobacco smokers.&#xD;
      Furthermore, a large range of plasma, urine and respiratory oxidative stress markers will be&#xD;
      quantified. By this way, we aim to demonstrate that e-cigarettes-induced systemic oxidative&#xD;
      stress could be linked to cardiovascular toxicity. To the best of our knowledge, this is the&#xD;
      first project that evaluates the effects of e-cigarettes vaping in comparison to tobacco&#xD;
      cigarette smoking on the cardiovascular system in relation to vaporization temperature,&#xD;
      nicotine delivery and oxidative stress.&#xD;
&#xD;
      Aims of the study: This study tests the following hypotheses: 1) acute high temperature&#xD;
      vaporization of propylene glycol and vegetable glycerin has no deleterious effects on&#xD;
      cardiovascular parameters in comparison to tobacco smoking; 2) Tobacco smoking rises plasma&#xD;
      and urine oxidative stress biomarkers. On the contrary, acute and chronic e-cigarettes vaping&#xD;
      don't rise these biomarkers. At a cellular level, plasma of smokers but not vapers increases&#xD;
      superoxide anion production.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in subcutaneous flux</measure>
    <time_frame>1 hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Plasma and urine oxidative stress markers</measure>
    <time_frame>1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in aortic stiffness</measure>
    <time_frame>10 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate variability</measure>
    <time_frame>10 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baroreflex sensitivity</measure>
    <time_frame>10 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Cardiovascular Risk Factor</condition>
  <arm_group>
    <arm_group_label>e-cigarette nic_O LT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>e-cigarette (without nicotine; low temperature)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>e-cigarette Nic_1 LT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>e-cigarette (with nicotine; low temperature)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>e-cigarette Nic_0 HT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>e-cigarette (without nicotine; high temperature)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>e-cigarette NIC_1 HT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>e-cigarette (with nicotine; high temperature)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tobacco cigarette</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tobacco cigarette</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>No E-cigarettes, Nor tobocco cigarettes</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>e-cigarette (PG+VG without nicotine; low temperature)</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>e-cigarette nic_O LT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>e-cigarette (PG+VG with nicotine; low temperature)</intervention_name>
    <arm_group_label>e-cigarette Nic_1 LT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>e-cigarette (PG+VG without nicotine; high temperature)</intervention_name>
    <arm_group_label>e-cigarette Nic_0 HT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>e-cigarette (PG+VG with nicotine; high temperature)</intervention_name>
    <arm_group_label>e-cigarette NIC_1 HT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>tobacco cigarette</intervention_name>
    <arm_group_label>Tobacco cigarette</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any form of cardiovascular disease&#xD;
&#xD;
          -  Any form of pulmonary disease like asthma or COPD&#xD;
&#xD;
          -  Any form of systemic or chronic disorder&#xD;
&#xD;
          -  Active allergy within 4 weeks of the study&#xD;
&#xD;
          -  Symptoms of infection or inflammation within 4 weeks of the study&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Paul Van Vooren</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Erasme</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erasme Hospital</name>
      <address>
        <city>Brussels</city>
        <state>Brabant</state>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université Libre de Bruxelles</investigator_affiliation>
    <investigator_full_name>Martin Chaumont</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>electronic cigarette</keyword>
  <keyword>e-cigarette</keyword>
  <keyword>oxidative stress</keyword>
  <keyword>tobacco smoking</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03036644
org study id: P2017/028 / B406201630672
nct id: NCT03036644
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: Electronic cigarettes (e-cigarettes) are battery-powered devices heating a liquid
      (e-liquid) composed of propylene glycol and/or vegetable glycerin, and most commonly,
      nicotine to form an aerosol (vapor) that is inhaled (i.e. "vaped"). Scarce and conflicting
      data are available regarding the cardiovascular toxicity of e-cigarettes. We wish to
      determine the acute effects of propylene glycol/vegetable glycerin and nicotine vaporization
      at high temperature in comparison to tobacco cigarette smoking on several advanced
      cardiovascular parameters in healthy chronic e-cigarettes users and tobacco smokers.
      Furthermore, a large range of plasma, urine and respiratory oxidative stress markers will be
      quantified. By this way, we aim to demonstrate that e-cigarettes-induced systemic oxidative
      stress could be linked to cardiovascular toxicity. To the best of our knowledge, this is the
      first project that evaluates the effects of e-cigarettes vaping in comparison to tobacco
      cigarette smoking on the cardiovascular system in relation to vaporization temperature,
      nicotine delivery and oxidative stress.

      Aims of the study: This study tests the following hypotheses: 1) acute high temperature
      vaporization of propylene glycol and vegetable glycerin has no deleterious effects on
      cardiovascular parameters in comparison to tobacco smoking; 2) Tobacco smoking rises plasma
      and urine oxidative stress biomarkers. On the contrary, acute and chronic e-cigarettes vaping
      don't rise these biomarkers. At a cellular level, plasma of smokers but not vapers increases
      superoxide anion production.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Change in subcutaneous flux
time frame: 1 hour
measure: Change in Plasma and urine oxidative stress markers
time frame: 1 hour
measure: Change in aortic stiffness
time frame: 10 minutes
measure: Change in heart rate variability
time frame: 10 minutes
measure: Change in baroreflex sensitivity
time frame: 10 minutes
arm group label: e-cigarette nic_O LT
arm group type: Experimental
description: e-cigarette (without nicotine; low temperature)
arm group label: e-cigarette Nic_1 LT
arm group type: Experimental
description: e-cigarette (with nicotine; low temperature)
arm group label: e-cigarette Nic_0 HT
arm group type: Experimental
description: e-cigarette (without nicotine; high temperature)
arm group label: e-cigarette NIC_1 HT
arm group type: Experimental
description: e-cigarette (with nicotine; high temperature)
arm group label: Tobacco cigarette
arm group type: Active Comparator
description: Tobacco cigarette
arm group label: Placebo
arm group type: Placebo Comparator
description: No E-cigarettes, Nor tobocco cigarettes
intervention type: Device
intervention name: e-cigarette (PG+VG without nicotine; low temperature)
arm group label: Placebo
arm group label: e-cigarette nic_O LT
intervention type: Device
intervention name: e-cigarette (PG+VG with nicotine; low temperature)
arm group label: e-cigarette Nic_1 LT
intervention type: Device
intervention name: e-cigarette (PG+VG without nicotine; high temperature)
arm group label: e-cigarette Nic_0 HT
intervention type: Device
intervention name: e-cigarette (PG+VG with nicotine; high temperature)
arm group label: e-cigarette NIC_1 HT
intervention type: Other
intervention name: tobacco cigarette
arm group label: Tobacco cigarette
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Paul Van Vooren
role: Study Director
affiliation: Hospital Erasme
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Université Libre de Bruxelles
investigator full name: Martin Chaumont
investigator title: Principal investigator
mesh term: Nicotine
sharing ipd: No