<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/NCT01713374</url>
  </required_header>
  <id_info>
    <org_study_id>PAN-1</org_study_id>
    <nct_id>NCT01713374</nct_id>
  </id_info>
  <brief_title>Physiological Assessment of the Endothelium - Circadian Rhythm and Role of the Sympathetic Nervous System</brief_title>
  <acronym>PAN</acronym>
  <official_title>Studies on the Physiological Meaning of Flow-mediated Constriction, Flow-mediated Dilatation and Vasomotion/Flowmotion: Circadian Variability and Role of the Sympathetic Nervous System.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johannes Gutenberg University Mainz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether interventions aimed at increasing&#xD;
      sympathetic tone modify endothelial function measures as assessed by the measurement of&#xD;
      flow-mediated dilation (FMD) and constriction (FMC). The investigators hypothesize that the&#xD;
      three interventions under study will increase FMC while causing a blunting in FMD.&#xD;
&#xD;
      Further, the investigators plan to study the circadian variability of FMC and FMD. The&#xD;
      investigators hypothesize a peak of FMD in the late hours of the day and a peak of FMC in the&#xD;
      early hours.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in FMD in response to sympathetic activation</measure>
    <time_frame>Change in FMD before versus 1 Minute after begin of intervention</time_frame>
    <description>Flow-mediated dilation will be measured at rest and during each of the interventions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in FMC during sympathetic activation</measure>
    <time_frame>Change in FMC before versus 1 minute after begin of each intervention</time_frame>
    <description>Change in Flow-mediated constriction induced by each of the interventions.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Endothelial Function</condition>
  <arm_group>
    <arm_group_label>Myogenic activation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of myogenic activation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cold pressure test</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of cold pressure test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mental stress</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of mental stress</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control visit - no intervention performed - subjects will undergo endothelial function measurement twice at a distance of 45 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mental stress</intervention_name>
    <description>Subjects will be asked to perform complex mathematic operations at a very fast pace</description>
    <arm_group_label>mental stress</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>control visit</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Myogenic activation</intervention_name>
    <description>A pneumatic cuff will be inflated to suprasystolic pressure around both thighs and the subjects will be asked to perform plantar flexion exercises.</description>
    <arm_group_label>Myogenic activation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cold pressure test</intervention_name>
    <description>A hand will be placed in ice-cold water.</description>
    <arm_group_label>Cold pressure test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteers with no cardiovascular risk factor, no current disease, normal&#xD;
             laboratory parameters and ECG.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any active disease&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tommaso Gori, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Mainz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center Mainz</name>
      <address>
        <city>Mainz</city>
        <state>Rheinland Pfalz</state>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>March 31, 2015</last_update_submitted>
  <last_update_submitted_qc>March 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johannes Gutenberg University Mainz</investigator_affiliation>
    <investigator_full_name>Tommaso Gori</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>endothelial function</keyword>
  <keyword>sympathetic nervous system</keyword>
  <!-- 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/NCT01713374
org study id: PAN-1
nct id: NCT01713374
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether interventions aimed at increasing
      sympathetic tone modify endothelial function measures as assessed by the measurement of
      flow-mediated dilation (FMD) and constriction (FMC). The investigators hypothesize that the
      three interventions under study will increase FMC while causing a blunting in FMD.

      Further, the investigators plan to study the circadian variability of FMC and FMD. The
      investigators hypothesize a peak of FMD in the late hours of the day and a peak of FMC in the
      early hours.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in FMD in response to sympathetic activation
time frame: Change in FMD before versus 1 Minute after begin of intervention
description: Flow-mediated dilation will be measured at rest and during each of the interventions.
measure: Change in FMC during sympathetic activation
time frame: Change in FMC before versus 1 minute after begin of each intervention
description: Change in Flow-mediated constriction induced by each of the interventions.
arm group label: Myogenic activation
arm group type: Active Comparator
description: Subjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of myogenic activation
arm group label: Cold pressure test
arm group type: Active Comparator
description: Subjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of cold pressure test
arm group label: mental stress
arm group type: Active Comparator
description: Subjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of mental stress
arm group label: Control
arm group type: Active Comparator
description: Control visit - no intervention performed - subjects will undergo endothelial function measurement twice at a distance of 45 minutes
intervention type: Procedure
intervention name: Mental stress
description: Subjects will be asked to perform complex mathematic operations at a very fast pace
arm group label: mental stress
intervention type: Other
intervention name: no intervention
description: control visit
arm group label: Control
intervention type: Procedure
intervention name: Myogenic activation
description: A pneumatic cuff will be inflated to suprasystolic pressure around both thighs and the subjects will be asked to perform plantar flexion exercises.
arm group label: Myogenic activation
intervention type: Procedure
intervention name: Cold pressure test
description: A hand will be placed in ice-cold water.
arm group label: Cold pressure test
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tommaso Gori, MD PhD
role: Principal Investigator
affiliation: University Medical Center Mainz
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Johannes Gutenberg University Mainz
investigator full name: Tommaso Gori
investigator title: Professor