<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/NCT01714674</url>
  </required_header>
  <id_info>
    <org_study_id>METC 12-3-033</org_study_id>
    <secondary_id>NL41071.068.12</secondary_id>
    <nct_id>NCT01714674</nct_id>
  </id_info>
  <brief_title>Nitrate and Exercise-induced Cardiac Troponin T in Type 2 Diabetes</brief_title>
  <acronym>NO troponin</acronym>
  <official_title>The Impact of Dietary Nitrate Supplementation on Exercise-induced Cardiac Troponin T Release in Type 2 Diabetic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Blood cardiac troponin T (cTnT) concentration is a widely used marker of acute cardiac&#xD;
      injury. Previous research has shown that type 2 diabetic patients may experience large&#xD;
      increments in cTnT levels over the subsequent hours following a single bout of&#xD;
      moderate-intensity endurance-type exercise. This phenomenon is likely attributed to cardiac&#xD;
      ischemia-reperfusion injury caused by reduced nitric oxide (NO) bioavailability. Recent&#xD;
      evidence indicates that ingestion of dietary nitrates dramatically increases the&#xD;
      bioavailability of NO, and as such, may be protective against cardiac ischemia-reperfusion&#xD;
      injury.&#xD;
&#xD;
      The investigators hypothesize that dietary nitrate supplementation blunts the rise in cTnT&#xD;
      levels following exercise in type 2 diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">May 2013</completion_date>
  <primary_completion_date type="Anticipated">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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac troponin T</measure>
    <time_frame>9 hours, hourly time intervals</time_frame>
    <description>Cardiac troponin T levels will be assessed before exercise and over the 6-hour period following a single session of exercise.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma nitrate</measure>
    <time_frame>9 hours, hourly time intervals</time_frame>
    <description>Cardiac troponin T levels will be assessed before exercise and over the 6-hour period following a single session of exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma nitrite</measure>
    <time_frame>9 hours, hourly time intervals</time_frame>
    <description>Plasma nitrite levels will be assessed before exercise and over the 6-hour period following a single session of exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>day</time_frame>
    <description>Blood pressure will be measured various time during the day.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Placebo beverage</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>the impact of placebo (no active substance) on exercise-induced cTnT release</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dietary nitrate beverage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The impact of dietary nitrate (active substance) on exercise-induced cTnT release</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary nitrate beverage</intervention_name>
    <description>ingestion of single dose NaNO3 beverage two hours prior to exercise bout</description>
    <arm_group_label>Dietary nitrate beverage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>NaCl beverage</intervention_name>
    <description>ingestion of single dose NaCl beverage two hours prior to exercise bout</description>
    <arm_group_label>Placebo beverage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  exercise-induced cTnT release (&gt;3ng/L)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HbA1c &lt;6.0% or &gt;10.0%&#xD;
&#xD;
          -  morbid obesity (BMI&gt;35 kg/m2)&#xD;
&#xD;
          -  incident cardiovascular events in the last year (heart attack, stroke&#xD;
&#xD;
          -  use medication which contain nitrates and/or having vasodilatory effects&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luc van Loon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht UMC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jan-Willem van Dijk, MSc</last_name>
    <phone>+31(0)433881394</phone>
    <email>janwillem.vandijk@maastrichtuniversity.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Maastricht UMC</name>
      <address>
        <city>Maastricht</city>
        <zip>6214 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jan-Willem van Dijk, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Luc van Loon, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://www.m3-research.nl/</url>
    <description>research unit</description>
  </link>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>October 31, 2012</last_update_submitted>
  <last_update_submitted_qc>October 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiac troponin T</keyword>
  <keyword>cTnT</keyword>
  <keyword>exercise</keyword>
  <keyword>dietary nitrate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT01714674
org study id: METC 12-3-033
secondary id: NL41071.068.12
nct id: NCT01714674
lead sponsor: 
has dmc: No
Blood cardiac troponin T (cTnT) concentration is a widely used marker of acute cardiac
      injury. Previous research has shown that type 2 diabetic patients may experience large
      increments in cTnT levels over the subsequent hours following a single bout of
      moderate-intensity endurance-type exercise. This phenomenon is likely attributed to cardiac
      ischemia-reperfusion injury caused by reduced nitric oxide (NO) bioavailability. Recent
      evidence indicates that ingestion of dietary nitrates dramatically increases the
      bioavailability of NO, and as such, may be protective against cardiac ischemia-reperfusion
      injury.

      The investigators hypothesize that dietary nitrate supplementation blunts the rise in cTnT
      levels following exercise in type 2 diabetic patients.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Cardiac troponin T
time frame: 9 hours, hourly time intervals
description: Cardiac troponin T levels will be assessed before exercise and over the 6-hour period following a single session of exercise.
measure: Plasma nitrate
time frame: 9 hours, hourly time intervals
description: Cardiac troponin T levels will be assessed before exercise and over the 6-hour period following a single session of exercise.
measure: Plasma nitrite
time frame: 9 hours, hourly time intervals
description: Plasma nitrite levels will be assessed before exercise and over the 6-hour period following a single session of exercise.
measure: Blood pressure
time frame: day
description: Blood pressure will be measured various time during the day.
arm group label: Placebo beverage
arm group type: Placebo Comparator
description: the impact of placebo (no active substance) on exercise-induced cTnT release
arm group label: Dietary nitrate beverage
arm group type: Active Comparator
description: The impact of dietary nitrate (active substance) on exercise-induced cTnT release
intervention type: Dietary Supplement
intervention name: Dietary nitrate beverage
description: ingestion of single dose NaNO3 beverage two hours prior to exercise bout
arm group label: Dietary nitrate beverage
intervention type: Dietary Supplement
intervention name: NaCl beverage
description: ingestion of single dose NaCl beverage two hours prior to exercise bout
arm group label: Placebo beverage
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Luc van Loon, PhD
role: Principal Investigator
affiliation: Maastricht UMC
last name: Jan-Willem van Dijk, MSc
phone: +31(0)433881394
email: janwillem.vandijk@maastrichtuniversity.nl
facility: 
status: Recruiting
investigator: 
investigator: 
country: Netherlands
url: http://www.m3-research.nl/
description: research unit
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2