<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/NCT03819517</url>
  </required_header>
  <id_info>
    <org_study_id>HM20014536</org_study_id>
    <nct_id>NCT03819517</nct_id>
  </id_info>
  <brief_title>Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease: a Mechanistic Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</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>
      Researchers have found a link between chronic obstructive pulmonary disease (COPD) and heart&#xD;
      disease; however, a link is all they have found. Cardiovascular health in COPD is controlled&#xD;
      by different mechanisms including vascular health and systemic inflammation. The&#xD;
      investigators have collected preliminary data to support that concentrations of Sirtuin 1&#xD;
      (Sirt1), a protein that plays a key role in cardioprotection, may be involved in&#xD;
      cardiovascular health in patients with COPD. Resveratrol, an over the counter natural&#xD;
      polyphenol found in a variety of food, is a direct activator of Sirt1 and has been used to&#xD;
      improve cardiovascular health in different cohorts. The current project is an attempt to&#xD;
      expand previous findings and explore the effects of the sub-chronic use of resveratrol in&#xD;
      sustaining the improvements in cardiovascular health in COPD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study is designed as a double-blind, randomized, cross-over, placebo-controlled&#xD;
      protocol. Patients with COPD will receive either resveratrol (500 mg) or placebo for 12&#xD;
      weeks. A comprehensive evaluation of cardiovascular health will be performed. Results will&#xD;
      provide novel insights into the mechanistic role that Sirt1 mediates in COPD related vascular&#xD;
      dysfunction and systemic inflammation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">August 30, 2022</completion_date>
  <primary_completion_date type="Actual">August 30, 2022</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Sirt1 concentrations</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Circulating concentrations of Sirt1 before and 12 weeks after both resveratrol and placebo</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in vascular health</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Assessment of vascular health through the evaluation of peripheral vascular using the flow-mediated dilation technique before and 12 weeks after both resveratrol and placebo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Systemic Inflammation</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Systemic inflammation will be evaluated through the assessment of interleukin concentrations using enzyme-linked immunosorbent assay before and 12 weeks after both resveratrol and placebo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Nitric Oxide metabolism</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Nitric oxide metabolism will be evaluated through Nitric oxide synthase expression using western blot analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Inflammatory activation</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>The inflammatory cascade of the nuclear factor kappa B will be evaluated through assessment of p65 and p50 expression using western blot analysis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Resveratrol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>500 mg of time released micronized trans-Resveratrol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be used in the form of an empty white colored soft vegetarian capsule as resveratrol is presented</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Resveratrol</intervention_name>
    <description>Over the counter supplementation</description>
    <arm_group_label>Resveratrol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Empty white colored soft vegetarian capsule</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with a clinical diagnosis of COPD known for at least one year will be&#xD;
             allowed to participate&#xD;
&#xD;
          -  Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages II to IV&#xD;
&#xD;
          -  Breathing test ratio (FEV1/FVC) &lt;0.7&#xD;
&#xD;
          -  Amount of exhaled air (FEV1) &lt;80% predicted after bronchodilator&#xD;
&#xD;
          -  Total Lung Capacity (TLC)&gt;80%&#xD;
&#xD;
          -  Matched healthy volunteers without COPD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  FEV1/FVC&gt;0.7&#xD;
&#xD;
          -  Clinical diagnosis of heart disease, hypertension or diabetes&#xD;
&#xD;
          -  Use of vasoactive medications (nitrates, Beta blockers)&#xD;
&#xD;
          -  Uncontrolled high blood pressure&#xD;
&#xD;
          -  Pulmonary hypertension&#xD;
&#xD;
          -  Fluid in the lungs&#xD;
&#xD;
          -  Sleep apnea&#xD;
&#xD;
          -  Thyroid problems&#xD;
&#xD;
          -  Anemia&#xD;
&#xD;
          -  Raynaud's phenomenon&#xD;
&#xD;
          -  Gastrointestinal bleeding&#xD;
&#xD;
          -  History of coagulopathies&#xD;
&#xD;
          -  History of low platelets&#xD;
&#xD;
          -  Gangrene of the digits&#xD;
&#xD;
          -  Phenylketonuria&#xD;
&#xD;
          -  Pregnant or women attempting to become pregnant&#xD;
&#xD;
          -  In lactation&#xD;
&#xD;
          -  Individuals who may not be able to read or understand the resveratrol label&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paula Rodriguez Miguelez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Resveratrol</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/NCT03819517
org study id: HM20014536
nct id: NCT03819517
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Researchers have found a link between chronic obstructive pulmonary disease (COPD) and heart
      disease; however, a link is all they have found. Cardiovascular health in COPD is controlled
      by different mechanisms including vascular health and systemic inflammation. The
      investigators have collected preliminary data to support that concentrations of Sirtuin 1
      (Sirt1), a protein that plays a key role in cardioprotection, may be involved in
      cardiovascular health in patients with COPD. Resveratrol, an over the counter natural
      polyphenol found in a variety of food, is a direct activator of Sirt1 and has been used to
      improve cardiovascular health in different cohorts. The current project is an attempt to
      expand previous findings and explore the effects of the sub-chronic use of resveratrol in
      sustaining the improvements in cardiovascular health in COPD.
The present study is designed as a double-blind, randomized, cross-over, placebo-controlled
      protocol. Patients with COPD will receive either resveratrol (500 mg) or placebo for 12
      weeks. A comprehensive evaluation of cardiovascular health will be performed. Results will
      provide novel insights into the mechanistic role that Sirt1 mediates in COPD related vascular
      dysfunction and systemic inflammation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Sirt1 concentrations
time frame: Baseline to 12 weeks
description: Circulating concentrations of Sirt1 before and 12 weeks after both resveratrol and placebo
measure: Change in vascular health
time frame: Baseline to 12 weeks
description: Assessment of vascular health through the evaluation of peripheral vascular using the flow-mediated dilation technique before and 12 weeks after both resveratrol and placebo.
measure: Change in Systemic Inflammation
time frame: Baseline to 12 weeks
description: Systemic inflammation will be evaluated through the assessment of interleukin concentrations using enzyme-linked immunosorbent assay before and 12 weeks after both resveratrol and placebo.
measure: Change in Nitric Oxide metabolism
time frame: Baseline to 12 weeks
description: Nitric oxide metabolism will be evaluated through Nitric oxide synthase expression using western blot analysis
measure: Change in Inflammatory activation
time frame: Baseline to 12 weeks
description: The inflammatory cascade of the nuclear factor kappa B will be evaluated through assessment of p65 and p50 expression using western blot analysis
arm group label: Resveratrol
arm group type: Active Comparator
description: 500 mg of time released micronized trans-Resveratrol
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo will be used in the form of an empty white colored soft vegetarian capsule as resveratrol is presented
intervention type: Dietary Supplement
intervention name: Resveratrol
description: Over the counter supplementation
arm group label: Resveratrol
intervention type: Other
intervention name: Placebo
description: Empty white colored soft vegetarian capsule
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Paula Rodriguez Miguelez, PhD
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Resveratrol
sharing ipd: No