<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/NCT02206074</url>
  </required_header>
  <id_info>
    <org_study_id>CRF107</org_study_id>
    <secondary_id>12/SW/0118</secondary_id>
    <nct_id>NCT02206074</nct_id>
  </id_info>
  <brief_title>The Effect of Dietary Nitrate Supplementation on Ability of Individuals With Type 2 Diabetes to Perform Exercise</brief_title>
  <acronym>Ex nit as</acronym>
  <official_title>The Effect of Dietary Nitrate Supplementation on Ability of Individuals With Type 2 Diabetes to Perform Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Exeter</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Diabetes UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Exeter</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are conducting a research study to see if increasing the amount of nitrate&#xD;
      (a substance found in large quantities in certain vegetables) in the diet can increase the&#xD;
      ability of individuals with Type 2 diabetes (T2D) to perform exercise. Some people with T2D&#xD;
      find exercise more uncomfortable than individuals who do not have T2D. This may be explained&#xD;
      by the experimental studies showing that T2D can result in reductions in the supply of oxygen&#xD;
      to the muscles. Studies have also shown that for a given level of activity, individuals with&#xD;
      T2D will be much closer to their maximum exercise capacity than healthy individuals. Dietary&#xD;
      nitrate may have two important beneficial effects in individuals with T2D: 1) The effects of&#xD;
      dietary nitrate on the responses to exercise may have a significant impact on the ability of&#xD;
      individuals with Type 2 diabetes to perform daily tasks and exercise more comfortably and 2)&#xD;
      experimental studies suggest that increased nitrate consumption has been shown to reduce the&#xD;
      amount of oxygen required for a given level of exercise.&#xD;
&#xD;
      The investigators will recruit 60 individuals with T2D. These people will take part in a&#xD;
      randomised crossover design study where they will be asked to drink normal beetroot juice&#xD;
      (rich in nitrate) and nitrate depleted beetroot juice, prior to performing two different&#xD;
      walking exercise tasks (a six minute walk and repeated, low intensity treadmill walking).&#xD;
      This study aims to determine if dietary nitrate supplementation reduces the amount of oxygen&#xD;
      required for a given level of exercise in individuals with T2D. To test brain function&#xD;
      individuals will be asked to perform a standard computerised decision making task following&#xD;
      consumption of the nitrate rich and nitrate depleted juices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pulmonary gas exchange via MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems</measure>
    <time_frame>3 x 6 minutes of gas exchange per participant, twice, 10-14 days apart</time_frame>
    <description>Pulmonary gas exchange was measured during treadmill walking exercise (MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems, St. Paul, MN, USA). Prior to each testing session the analysers were calibrated using known concentrations. The volume transducer was calibrated using a 3-litre syringe (Hans Rudolph, Kansas City, MO, USA). When we refer to the oxygen cost of exercise we are referring to end exercise oxygen uptake.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional capacity measured by 6-Minute Walking Test (6MWT)</measure>
    <time_frame>6 minutes walking per participant per visit</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>T2DM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Crossover design where participants will start in the Beetroot juice condition, and after a washout period, move into the other condition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Crossover design where participants will start in the placebo condition, and after a washout period, move into the other condition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Beetroot</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>T2DM</arm_group_label>
    <other_name>James Whites Drinks beetroot sports shot</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with T2D (as defined by WHO) of at least 5 years duration between the ages of&#xD;
             35-75 will be invited.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with significant renal impairment (eGFR&lt;30)&#xD;
&#xD;
          -  uncontrolled hypertension&#xD;
&#xD;
          -  BMI&lt;25 or &gt;35&#xD;
&#xD;
          -  are taking regular organic nitrates, nicorandil, or thiazolidinidiones, or any&#xD;
             medication which may interfere with data interpretation or safety&#xD;
&#xD;
          -  who have had a myocardial infarction or cerebro-vascular event&#xD;
&#xD;
          -  who smoke, or any other serious medical condition which would interfere with data&#xD;
             interpretation or safety will be excluded from participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daryl Wilkerson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Exeter</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peninsula NIHr Exeter Clinical Research Facility</name>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>March 15, 2019</last_update_submitted>
  <last_update_submitted_qc>March 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT02206074
org study id: CRF107
secondary id: 12/SW/0118
nct id: NCT02206074
lead sponsor: 
collaborator: 
has dmc: No
The investigators are conducting a research study to see if increasing the amount of nitrate
      (a substance found in large quantities in certain vegetables) in the diet can increase the
      ability of individuals with Type 2 diabetes (T2D) to perform exercise. Some people with T2D
      find exercise more uncomfortable than individuals who do not have T2D. This may be explained
      by the experimental studies showing that T2D can result in reductions in the supply of oxygen
      to the muscles. Studies have also shown that for a given level of activity, individuals with
      T2D will be much closer to their maximum exercise capacity than healthy individuals. Dietary
      nitrate may have two important beneficial effects in individuals with T2D: 1) The effects of
      dietary nitrate on the responses to exercise may have a significant impact on the ability of
      individuals with Type 2 diabetes to perform daily tasks and exercise more comfortably and 2)
      experimental studies suggest that increased nitrate consumption has been shown to reduce the
      amount of oxygen required for a given level of exercise.

      The investigators will recruit 60 individuals with T2D. These people will take part in a
      randomised crossover design study where they will be asked to drink normal beetroot juice
      (rich in nitrate) and nitrate depleted beetroot juice, prior to performing two different
      walking exercise tasks (a six minute walk and repeated, low intensity treadmill walking).
      This study aims to determine if dietary nitrate supplementation reduces the amount of oxygen
      required for a given level of exercise in individuals with T2D. To test brain function
      individuals will be asked to perform a standard computerised decision making task following
      consumption of the nitrate rich and nitrate depleted juices.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Pulmonary gas exchange via MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems
time frame: 3 x 6 minutes of gas exchange per participant, twice, 10-14 days apart
description: Pulmonary gas exchange was measured during treadmill walking exercise (MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems, St. Paul, MN, USA). Prior to each testing session the analysers were calibrated using known concentrations. The volume transducer was calibrated using a 3-litre syringe (Hans Rudolph, Kansas City, MO, USA). When we refer to the oxygen cost of exercise we are referring to end exercise oxygen uptake.
measure: Functional capacity measured by 6-Minute Walking Test (6MWT)
time frame: 6 minutes walking per participant per visit
arm group label: T2DM
arm group type: Active Comparator
description: Crossover design where participants will start in the Beetroot juice condition, and after a washout period, move into the other condition.
arm group label: Placebo
arm group type: Placebo Comparator
description: Crossover design where participants will start in the placebo condition, and after a washout period, move into the other condition.
intervention type: Dietary Supplement
intervention name: Beetroot
arm group label: Placebo
arm group label: T2DM
other name: James Whites Drinks beetroot sports shot
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: No
last name: Daryl Wilkerson, PhD
role: Principal Investigator
affiliation: University of Exeter
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2