<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/NCT03285386</url>
  </required_header>
  <id_info>
    <org_study_id>LiverpoolHopeUni</org_study_id>
    <nct_id>NCT03285386</nct_id>
  </id_info>
  <brief_title>Priming Exercise in Type 1 Diabetes</brief_title>
  <acronym>PET1D</acronym>
  <official_title>The Effects of Prior Exercise on Pulmonary Oxygen Uptake Kinetics and the Power-Duration Relationship in Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liverpool Hope University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Liverpool Hope University</source>
  <oversight_info>
    <has_dmc>No</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>
      Critical power is an important threshold in exercise physiology, and is an important&#xD;
      determinant of the ability to tolerate high-intensity exercise. The ability to tolerate such&#xD;
      exercise is drastically impaired in certain chronic conditions, such as type 1 diabetes.&#xD;
      Whilst the most important physiological factors that determine critical power have yet to be&#xD;
      determined, previous work from our laboratory suggests that it is related to the speed of&#xD;
      oxygen uptake at the onset of exercise. This study will look to utilise &quot;priming&quot; exercise as&#xD;
      an intervention to improve the speed of these oxygen uptake &quot;kinetics&quot;, and thus critical&#xD;
      power and exercise tolerance in individuals with type 1 diabetes. We hypothesize that oxygen&#xD;
      uptake kinetics will be faster and critical power will be higher when exercise is performed&#xD;
      with compared to without a prior bout of high-intensity priming exercise in a population of&#xD;
      individuals with type 1 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ability to tolerate high-intensity exercise, or exercise tolerance, is a key factor that&#xD;
      can influence clinical outcomes in a range of conditions. The &quot;critical power&quot; is an&#xD;
      important physiological threshold that demarcates exercise intensities that can be sustained&#xD;
      for prolonged periods (i.e. below critical power) from intensities that result in exhaustion&#xD;
      in a relatively short period of time (i.e. 2-30 minutes, above critical power). Critical&#xD;
      power is therefore a key determinant of exercise tolerance. The speed with which oxygen&#xD;
      uptake rises at the onset of exercise (i.e. oxygen uptake &quot;kinetics&quot;) has been shown by work&#xD;
      from our laboratory to be a key determinant of critical power. One intervention that can&#xD;
      acutely improve the oxygen uptake kinetics is the performance of a prior bout of&#xD;
      high-intensity exercise, known as &quot;priming exercise&quot;. Patients with type 1 diabetes have&#xD;
      previously been shown to have impaired exercise tolerance compared to healthy controls. The&#xD;
      performance of priming exercise therefore represents a potential intervention to acutely&#xD;
      improve oxygen uptake kinetics, and therefore critical power and exercise tolerance, in type&#xD;
      1 diabetic individuals. The purpose of this study is therefore to assess the influence of&#xD;
      priming exercise on oxygen uptake kinetics and critical power in a population of type 1&#xD;
      diabetic individuals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</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>
    <intervention_model_description>Participants will serve as their own controls. Participants will alternate between &quot;primed&quot; (experimental condition) and &quot;non-primed&quot; (control condition) in their visits.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Critical power</measure>
    <time_frame>3-9 weeks</time_frame>
    <description>The power asymptote of the hyperbolic relationship between power and the tolerable duration of exercise.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase II time constant of pulmonary oxygen uptake kinetics</measure>
    <time_frame>3-9 weeks</time_frame>
    <description>Time taken for oxygen uptake to attain 63% of its asymptotic amplitude.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time constant for muscle deoxygenation kinetics (assessed by near-infrared spectroscopy)</measure>
    <time_frame>3-9 weeks</time_frame>
    <description>Time taken for muscle deoxyhaemoglobin to attain 63% of its asymptotic amplitude.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>W'</measure>
    <time_frame>3-9 weeks</time_frame>
    <description>Curvature constant of the power-duration relationship. Finite work capacity available above critical power.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time constant for heart rate kinetics</measure>
    <time_frame>3-9 weeks</time_frame>
    <description>Time taken for heart rate to attain 63% of its asymptotic amplitude.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Priming Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will perform constant power output tests at four separate, fixed intensities to exhaustion on a cycle ergometer on separate days. These exhaustive, constant power tests will be preceded by 3 minutes of light cycling, 6 minutes of high intensity cycling, 7 minutes of rest and 3 minutes of light cycling.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will perform constant power output tests at four separate, fixed intensities to exhaustion on a cycle ergometer on separate days. These exhaustive, constant power tests will be preceded by 3 minutes of light cycling only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Priming exercise</intervention_name>
    <description>All participants will perform a bout of high-intensity &quot;priming&quot; exercise for 6 minutes, 10 minutes prior to undertaking an exhaustive exercise test on four separate occasions.</description>
    <arm_group_label>Priming Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control Exercise</intervention_name>
    <description>All participants will perform 3 minutes of baseline cycling prior to undertaking an exhaustive exercise test on four separate occasions.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Suffering from Type 1 diabetes with a diagnosed disease duration of 2 - 20 years and no&#xD;
        comorbidities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        History of stroke, congestive heart failure, hypertension, or cardiopulmonary disease.&#xD;
&#xD;
        Current smoking or have been smoking within the last 12 months Symptomatic autonomic or&#xD;
        distal neuropathy HbA1c &gt; 64 mmol/mol Hypoglycaemia unawareness in the last 6 months Taking&#xD;
        any medications other than insulin.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richie P Goulding</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liverpool Hope University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Liverpool Hope University</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L169JD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Goulding RP, Roche DM, Marwood S. Prior exercise speeds pulmonary oxygen uptake kinetics and increases critical power during supine but not upright cycling. Exp Physiol. 2017 Sep 1;102(9):1158-1176. doi: 10.1113/EP086304. Epub 2017 Jul 26.</citation>
    <PMID>28627041</PMID>
  </reference>
  <reference>
    <citation>Behnke BJ, Kindig CA, McDonough P, Poole DC, Sexton WL. Dynamics of microvascular oxygen pressure during rest-contraction transition in skeletal muscle of diabetic rats. Am J Physiol Heart Circ Physiol. 2002 Sep;283(3):H926-32. doi: 10.1152/ajpheart.00059.2002.</citation>
    <PMID>12181120</PMID>
  </reference>
  <reference>
    <citation>Sexton WL, Poole DC, Mathieu-Costello O. Microcirculatory structure-function relationships in skeletal muscle of diabetic rats. Am J Physiol. 1994 Apr;266(4 Pt 2):H1502-11. doi: 10.1152/ajpheart.1994.266.4.H1502. Erratum In: Am J Physiol 1994 Jun;266(6 Pt 2):section H followi.</citation>
    <PMID>8184927</PMID>
  </reference>
  <reference>
    <citation>Kindig CA, Sexton WL, Fedde MR, Poole DC. Skeletal muscle microcirculatory structure and hemodynamics in diabetes. Respir Physiol. 1998 Feb;111(2):163-75. doi: 10.1016/s0034-5687(97)00122-9.</citation>
    <PMID>9574868</PMID>
  </reference>
  <reference>
    <citation>Burnley M, Davison G, Baker JR. Effects of priming exercise on VO2 kinetics and the power-duration relationship. Med Sci Sports Exerc. 2011 Nov;43(11):2171-9. doi: 10.1249/MSS.0b013e31821ff26d.</citation>
    <PMID>21552161</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>February 28, 2019</last_update_submitted>
  <last_update_submitted_qc>February 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 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 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Anonymized participant data will be made available to the public in the form of research presentations and a journal article. Anonymized individual participant data not featured in either the journal article or presentations will only be made available upon request to the authors.</ipd_description>
  </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/NCT03285386
org study id: LiverpoolHopeUni
nct id: NCT03285386
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Critical power is an important threshold in exercise physiology, and is an important
      determinant of the ability to tolerate high-intensity exercise. The ability to tolerate such
      exercise is drastically impaired in certain chronic conditions, such as type 1 diabetes.
      Whilst the most important physiological factors that determine critical power have yet to be
      determined, previous work from our laboratory suggests that it is related to the speed of
      oxygen uptake at the onset of exercise. This study will look to utilise "priming" exercise as
      an intervention to improve the speed of these oxygen uptake "kinetics", and thus critical
      power and exercise tolerance in individuals with type 1 diabetes. We hypothesize that oxygen
      uptake kinetics will be faster and critical power will be higher when exercise is performed
      with compared to without a prior bout of high-intensity priming exercise in a population of
      individuals with type 1 diabetes.
The ability to tolerate high-intensity exercise, or exercise tolerance, is a key factor that
      can influence clinical outcomes in a range of conditions. The "critical power" is an
      important physiological threshold that demarcates exercise intensities that can be sustained
      for prolonged periods (i.e. below critical power) from intensities that result in exhaustion
      in a relatively short period of time (i.e. 2-30 minutes, above critical power). Critical
      power is therefore a key determinant of exercise tolerance. The speed with which oxygen
      uptake rises at the onset of exercise (i.e. oxygen uptake "kinetics") has been shown by work
      from our laboratory to be a key determinant of critical power. One intervention that can
      acutely improve the oxygen uptake kinetics is the performance of a prior bout of
      high-intensity exercise, known as "priming exercise". Patients with type 1 diabetes have
      previously been shown to have impaired exercise tolerance compared to healthy controls. The
      performance of priming exercise therefore represents a potential intervention to acutely
      improve oxygen uptake kinetics, and therefore critical power and exercise tolerance, in type
      1 diabetic individuals. The purpose of this study is therefore to assess the influence of
      priming exercise on oxygen uptake kinetics and critical power in a population of type 1
      diabetic individuals.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Participants will serve as their own controls. Participants will alternate between "primed" (experimental condition) and "non-primed" (control condition) in their visits.
primary purpose: Basic Science
masking: None (Open Label)
measure: Critical power
time frame: 3-9 weeks
description: The power asymptote of the hyperbolic relationship between power and the tolerable duration of exercise.
measure: Phase II time constant of pulmonary oxygen uptake kinetics
time frame: 3-9 weeks
description: Time taken for oxygen uptake to attain 63% of its asymptotic amplitude.
measure: Time constant for muscle deoxygenation kinetics (assessed by near-infrared spectroscopy)
time frame: 3-9 weeks
description: Time taken for muscle deoxyhaemoglobin to attain 63% of its asymptotic amplitude.
measure: W'
time frame: 3-9 weeks
description: Curvature constant of the power-duration relationship. Finite work capacity available above critical power.
measure: Time constant for heart rate kinetics
time frame: 3-9 weeks
description: Time taken for heart rate to attain 63% of its asymptotic amplitude.
arm group label: Priming Exercise
arm group type: Experimental
description: Participants will perform constant power output tests at four separate, fixed intensities to exhaustion on a cycle ergometer on separate days. These exhaustive, constant power tests will be preceded by 3 minutes of light cycling, 6 minutes of high intensity cycling, 7 minutes of rest and 3 minutes of light cycling.
arm group label: Control
arm group type: Active Comparator
description: Participants will perform constant power output tests at four separate, fixed intensities to exhaustion on a cycle ergometer on separate days. These exhaustive, constant power tests will be preceded by 3 minutes of light cycling only.
intervention type: Behavioral
intervention name: Priming exercise
description: All participants will perform a bout of high-intensity "priming" exercise for 6 minutes, 10 minutes prior to undertaking an exhaustive exercise test on four separate occasions.
arm group label: Priming Exercise
intervention type: Behavioral
intervention name: Control Exercise
description: All participants will perform 3 minutes of baseline cycling prior to undertaking an exhaustive exercise test on four separate occasions.
arm group label: Control
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Richie P Goulding
role: Principal Investigator
affiliation: Liverpool Hope University
facility: 
country: United Kingdom
citation: Goulding RP, Roche DM, Marwood S. Prior exercise speeds pulmonary oxygen uptake kinetics and increases critical power during supine but not upright cycling. Exp Physiol. 2017 Sep 1;102(9):1158-1176. doi: 10.1113/EP086304. Epub 2017 Jul 26.
PMID: 28627041
citation: Behnke BJ, Kindig CA, McDonough P, Poole DC, Sexton WL. Dynamics of microvascular oxygen pressure during rest-contraction transition in skeletal muscle of diabetic rats. Am J Physiol Heart Circ Physiol. 2002 Sep;283(3):H926-32. doi: 10.1152/ajpheart.00059.2002.
PMID: 12181120
citation: Sexton WL, Poole DC, Mathieu-Costello O. Microcirculatory structure-function relationships in skeletal muscle of diabetic rats. Am J Physiol. 1994 Apr;266(4 Pt 2):H1502-11. doi: 10.1152/ajpheart.1994.266.4.H1502. Erratum In: Am J Physiol 1994 Jun;266(6 Pt 2):section H followi.
PMID: 8184927
citation: Kindig CA, Sexton WL, Fedde MR, Poole DC. Skeletal muscle microcirculatory structure and hemodynamics in diabetes. Respir Physiol. 1998 Feb;111(2):163-75. doi: 10.1016/s0034-5687(97)00122-9.
PMID: 9574868
citation: Burnley M, Davison G, Baker JR. Effects of priming exercise on VO2 kinetics and the power-duration relationship. Med Sci Sports Exerc. 2011 Nov;43(11):2171-9. doi: 10.1249/MSS.0b013e31821ff26d.
PMID: 21552161
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No
ipd description: Anonymized participant data will be made available to the public in the form of research presentations and a journal article. Anonymized individual participant data not featured in either the journal article or presentations will only be made available upon request to the authors.