<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/NCT01717339</url>
  </required_header>
  <id_info>
    <org_study_id>12-006285</org_study_id>
    <nct_id>NCT01717339</nct_id>
  </id_info>
  <brief_title>Sleep Apnea and Vascular Function</brief_title>
  <official_title>Sleep Apnea and Vascular Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obstructive sleep apnea (OSA) is associated with endothelial dysfunction and the development&#xD;
      of cardiovascular disease. It is unclear how OSA results in endothelial dysfunction, but&#xD;
      given the association between OSA and obesity, adipose-derived hormones (adipokines) are&#xD;
      likely to be involved. Leptin, an adipokine upregulated in patients with OSA, has been shown&#xD;
      to be associated with deleterious effects on vascular function resulting in impaired&#xD;
      endothelial function. This proposal is directed at investigating the molecular mechanisms of&#xD;
      endothelial dysfunction in OSA patients. We hypothesize that endothelial dysfunction&#xD;
      associated with OSA is a result of molecular alterations within endothelial cells. As a part&#xD;
      of these studies we will look at NO signaling pathways in adipose tissue and microvessels&#xD;
      from normal and OSA subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</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>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Brachial artery diameter in response to hyperemia.</measure>
    <time_frame>Baseline and 15 min after hyperemia</time_frame>
    <description>Endothelial function test - Arterial endothelial function will be assessed non-invasively by ultrasound examination of the arterial endothelium dependent vasodilation response to reactive hyperemia. The right brachial artery, proximal to the antecubital fossa, will be imaged longitudinally using a linear-array transducer. Flow-mediated endothelium-dependent vasodilation will be assessed by measuring the brachial artery diameter at baseline and during reactive hyperemia. Reactive hyperemia will be induced by deflating a cuff previously inflated to 200 mmHg for 5 minutes in the forearm. Variables will be measured for three consecutive cardiac cycles and the average will be taken.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>OSA</condition>
  <arm_group>
    <arm_group_label>Normal Subjects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Non-OSA (Obstructive sleep apnea) patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OSA subjects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>(Obstructive sleep apnea) OSA subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sleep Study</intervention_name>
    <arm_group_label>Normal Subjects</arm_group_label>
    <arm_group_label>OSA subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non OSA, and newly diagnosed OSA subjects, naïve to CPAP treatment, aged 18-65 years,&#xD;
             with BMI less than or equal to 55 kg/m2, who are free of all chronic diseases&#xD;
             including diabetes, and cardiovascular diseases, will be recruited for our study.&#xD;
             Subjects with dyslipidemia and hypertension will be allowed to participate in the&#xD;
             study. Subjects taking anti-depressents, and anithypertensives will be allowed to&#xD;
             participate in the study. Also, subjects taking beta blockers and beta agonists will&#xD;
             be allowed to participate in the study.&#xD;
&#xD;
        If a subject is on aspirin or any other anti-inflammatory medication but free of known&#xD;
        vascular disease and depending on the indication, the study doctor may ask the subject to&#xD;
        suspend aspirin or anti-inflammatory therapy for 7 days prior to participation in the&#xD;
        study. In the event that the subjects does not stop the aspirin or other anti-inflammatory&#xD;
        medication, they will not be able to participate in the study because of the risk of&#xD;
        bleeding during the fat biopsy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body weight &gt;450 pounds (204.5kg)&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Anemic (hemoglobin &lt;13.5 g/dL for men and &lt;12.0 g/dL for women.&#xD;
&#xD;
          -  Postmenopausal&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Use of chronic Medications (aspirin, statins, anti-inflammatory drugs)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Virend K Somers, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>November 8, 2017</last_update_submitted>
  <last_update_submitted_qc>November 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Virend Somers</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</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/NCT01717339
org study id: 12-006285
nct id: NCT01717339
lead sponsor: 
has dmc: No
Obstructive sleep apnea (OSA) is associated with endothelial dysfunction and the development
      of cardiovascular disease. It is unclear how OSA results in endothelial dysfunction, but
      given the association between OSA and obesity, adipose-derived hormones (adipokines) are
      likely to be involved. Leptin, an adipokine upregulated in patients with OSA, has been shown
      to be associated with deleterious effects on vascular function resulting in impaired
      endothelial function. This proposal is directed at investigating the molecular mechanisms of
      endothelial dysfunction in OSA patients. We hypothesize that endothelial dysfunction
      associated with OSA is a result of molecular alterations within endothelial cells. As a part
      of these studies we will look at NO signaling pathways in adipose tissue and microvessels
      from normal and OSA subjects.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in Brachial artery diameter in response to hyperemia.
time frame: Baseline and 15 min after hyperemia
description: Endothelial function test - Arterial endothelial function will be assessed non-invasively by ultrasound examination of the arterial endothelium dependent vasodilation response to reactive hyperemia. The right brachial artery, proximal to the antecubital fossa, will be imaged longitudinally using a linear-array transducer. Flow-mediated endothelium-dependent vasodilation will be assessed by measuring the brachial artery diameter at baseline and during reactive hyperemia. Reactive hyperemia will be induced by deflating a cuff previously inflated to 200 mmHg for 5 minutes in the forearm. Variables will be measured for three consecutive cardiac cycles and the average will be taken.
arm group label: Normal Subjects
arm group type: Other
description: Non-OSA (Obstructive sleep apnea) patients
arm group label: OSA subjects
arm group type: Other
description: (Obstructive sleep apnea) OSA subjects
intervention type: Other
intervention name: Sleep Study
arm group label: Normal Subjects
arm group label: OSA subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Virend K Somers, MD PhD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Virend Somers
investigator title: PI
mesh term: Sleep Apnea Syndromes