<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/NCT03787836</url>
  </required_header>
  <id_info>
    <org_study_id>2018-168</org_study_id>
    <nct_id>NCT03787836</nct_id>
  </id_info>
  <brief_title>Improving Individual Glycemic Response With Exercise Intensity</brief_title>
  <acronym>INTENSITY</acronym>
  <official_title>Improving Individual Glycemic Response With Exercise Intensity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Brunswick</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heart and Stroke Foundation of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>New Brunswick Health Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of New Brunswick</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>
      Large interindividual variability exists in the glycemic response to exercise program,&#xD;
      resulting in a subset of individuals known as exercise non-responders (NRs). Increasing the&#xD;
      intensity of an exercise intervention has been proposed as one method for rescuing NRs by&#xD;
      producing beneficial changes. However, this theory has not been tested on NRs classified&#xD;
      using glycemic outcomes. This study will evaluate if increasing the intensity of an exercise&#xD;
      intervention will elicit a response within previous exercise NRs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Exercise can effectively slow the progression towards Type 2 diabetes (T2D). However, data&#xD;
      suggest large interindividual variability exists in glycemic response to exercise, resulting&#xD;
      in a subset of individuals known as exercise non-responders (NRs). Emerging research proposes&#xD;
      that altering the parameters of an exercise intervention to provide a sufficient stimulus can&#xD;
      elicit a response in those previously identified as NRs. To date, no research has attempted&#xD;
      to rescue previously classified NRs based on glycemic outcomes by altering the parameters of&#xD;
      an exercise intervention.&#xD;
&#xD;
      This study will implement an exercise program targeted at achieving the Canadian Physical&#xD;
      Activity Guidelines, and calculate the number of NRs. We will then evaluate if increasing the&#xD;
      intensity of exercise will elicit response to the treatment in the NRs.&#xD;
&#xD;
      Sixty adults living with prediabetes or T2D will be recruited into one of a control group, or&#xD;
      an exercise group. The exercising participants will begin a 16-week exercise intervention,&#xD;
      targeted at achieving 150 minutes of moderate to vigorous intensity (equating to 4.5 METs)&#xD;
      aerobic physical activity per week. Following the 16-week exercise program, participants will&#xD;
      be randomized into two groups, each completing an additional 12 weeks of exercise. The first&#xD;
      will maintain the same time and intensity, while the other will complete the 150 minutes per&#xD;
      week at an intensity equal to 6.0 METs. Randomization will occur in blocks in order to ensure&#xD;
      an equal number of NRs in each group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will first be randomized as controls or exercisers. All exercisers will complete a 16 week exercise program, then be randomized into two groups. The first group will increase the exercise intensity and conduct another 12 week program. The second group will continue the original program for an additional 12 weeks.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exercise responders following initial program</measure>
    <time_frame>Week 17</time_frame>
    <description>The number of responders to the original 16-week exercise program, based on improvement in glycated hemoglobin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exercise responders following additional exercise program</measure>
    <time_frame>Week 30</time_frame>
    <description>The number of responders following the additional 12-week exercise program, based on improvement in glycated hemoglobin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sex</measure>
    <time_frame>Baseline</time_frame>
    <description>Participant self-reported biological sex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family history of cardiovascular disease</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-reported family history of cardiovascular disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family history of cardiometabolic disease</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-reported family history of cardiometabolic disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Current medication use</measure>
    <time_frame>Baseline</time_frame>
    <description>Record of quantity and dose of current medications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity patterns</measure>
    <time_frame>Baseline</time_frame>
    <description>Participant self-reported physical activity patterns and daily step counts over a 7-day period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily step count</measure>
    <time_frame>Baseline</time_frame>
    <description>Daily step count as recorded over a 7-day period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass</measure>
    <time_frame>Baseline, week 17 and week 30</time_frame>
    <description>Body mass (kilograms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Baseline, week 17 and week 30</time_frame>
    <description>Height (centimetres)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Baseline, week 17 and week 30</time_frame>
    <description>Waist circumference (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat mass</measure>
    <time_frame>Baseline, week 17 and week 30</time_frame>
    <description>Fat mass (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat free mass</measure>
    <time_frame>Baseline, week 17 and week 30</time_frame>
    <description>Fat free mass (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiorespiratory fitness</measure>
    <time_frame>Baseline, week 17 and week 30</time_frame>
    <description>VO2 peak</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>Baseline, week 17, week 30</time_frame>
    <description>Weight (kilograms) and height (measured in centimetres and converted to metres) will be combined to report body mass index in kg/m^2</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>PreDiabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Exercise</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The primary purpose of the control participants are to provide a measure of variability. They will be used in our calculations of typical error to classify participants as responders or non-responders, and to quantify inter-individual variability.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercisers (Maintained)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The maintained exercise group will complete the original 16-week exercise intervention at an intensity of 4.5 metabolic equivalents (METs), and repeat the intervention for another 12-weeks following its completion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercisers (Increased Intensity)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The increased intensity exercise group will complete the original 16-week exercise intervention, followed by an additional 12 week intervention completed at an intensity of 6.0 METs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Maintained Exercise</intervention_name>
    <description>Complete 28 weeks of aerobic exercise, with one week (following week 16) for testing.&#xD;
Week 1 - 16 Intensity: 4.5 metabolic equivalents (METs).&#xD;
Duration:&#xD;
Week 1: 80 minutes Week 2: 100 minutes Week 3: 120 minutes Week 4: 135 minutes Week 5 - 16: 150 minutes/week&#xD;
Week 17: Physiological Testing&#xD;
Week 18 - 29 Intensity: 4.5 METs Duration: 150 minutes/week&#xD;
All exercise must be completed across a minimum of two sessions per week. Sub-maximal exercise tests will be completed every 4 weeks to adjust intensity.</description>
    <arm_group_label>Exercisers (Maintained)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Increased Intensity</intervention_name>
    <description>Complete 28 weeks of aerobic exercise, with one week (following week 16) for testing.&#xD;
Week 1 - 16 Intensity: 4.5 metabolic equivalents (METs).&#xD;
Duration:&#xD;
Week 1: 80 minutes Week 2: 100 minutes Week 3: 120 minutes Week 4: 135 minutes Week 5 - 16: 150 minutes/week&#xD;
Week 17: Physiological Testing&#xD;
Week 18 - 29 Intensity: 6.0 METs Duration: 150 minutes/week&#xD;
All exercise must be completed across a minimum of two sessions per week. Sub-maximal exercise tests will be completed every 4 weeks to adjust intensity.</description>
    <arm_group_label>Exercisers (Increased Intensity)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Community-dwelling adults aged 19 years or older.&#xD;
&#xD;
          2. Currently living with prediabetes or T2DM as diagnosed by a physician and confirmed by&#xD;
             an HbA1c value of 5.7% or above, as verified by duplicate testing.&#xD;
&#xD;
          3. Not currently partaking in a self-reported regular physical activity regimen, defined&#xD;
             as consistent participation in running or jogging activity, attending physical&#xD;
             activity or exercise classes on a weekly basis, or averaging 10,000 steps per day or&#xD;
             more over the course of 7 days.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Self reported as currently diagnosed as having, or being treated for, low iron&#xD;
             concentrations or anemia.&#xD;
&#xD;
          2. Diagnosed with any red blood cell altering condition.&#xD;
&#xD;
          3. Currently living with any cardiovascular disease which would impact the ability to&#xD;
             safely participate in exercise training.&#xD;
&#xD;
          4. Currently prescribed any medication which would impact the ability to use a heart rate&#xD;
             monitor to accurately track exercise intensity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Senechal, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New Brunswick</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of New Brunswick</name>
      <address>
        <city>Fredericton</city>
        <state>New Brunswick</state>
        <zip>E3B 5A3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Hecksteden A, Pitsch W, Rosenberger F, Meyer T. Repeated testing for the assessment of individual response to exercise training. J Appl Physiol (1985). 2018 Jun 1;124(6):1567-1579. doi: 10.1152/japplphysiol.00896.2017. Epub 2018 Jan 11.</citation>
    <PMID>29357481</PMID>
  </reference>
  <reference>
    <citation>Montero D, Lundby C. Refuting the myth of non-response to exercise training: 'non-responders' do respond to higher dose of training. J Physiol. 2017 Jun 1;595(11):3377-3387. doi: 10.1113/JP273480. Epub 2017 May 14. Erratum In: J Physiol. 2018 Apr 1;596(7):1311.</citation>
    <PMID>28133739</PMID>
  </reference>
  <reference>
    <citation>de Lannoy L, Clarke J, Stotz PJ, Ross R. Effects of intensity and amount of exercise on measures of insulin and glucose: Analysis of inter-individual variability. PLoS One. 2017 May 11;12(5):e0177095. doi: 10.1371/journal.pone.0177095. eCollection 2017.</citation>
    <PMID>28493912</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Brunswick</investigator_affiliation>
    <investigator_full_name>Martin Senechal</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Exercise Response</keyword>
  <keyword>Interindividual Variability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_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/NCT03787836
org study id: 2018-168
nct id: NCT03787836
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Large interindividual variability exists in the glycemic response to exercise program,
      resulting in a subset of individuals known as exercise non-responders (NRs). Increasing the
      intensity of an exercise intervention has been proposed as one method for rescuing NRs by
      producing beneficial changes. However, this theory has not been tested on NRs classified
      using glycemic outcomes. This study will evaluate if increasing the intensity of an exercise
      intervention will elicit a response within previous exercise NRs.
Exercise can effectively slow the progression towards Type 2 diabetes (T2D). However, data
      suggest large interindividual variability exists in glycemic response to exercise, resulting
      in a subset of individuals known as exercise non-responders (NRs). Emerging research proposes
      that altering the parameters of an exercise intervention to provide a sufficient stimulus can
      elicit a response in those previously identified as NRs. To date, no research has attempted
      to rescue previously classified NRs based on glycemic outcomes by altering the parameters of
      an exercise intervention.

      This study will implement an exercise program targeted at achieving the Canadian Physical
      Activity Guidelines, and calculate the number of NRs. We will then evaluate if increasing the
      intensity of exercise will elicit response to the treatment in the NRs.

      Sixty adults living with prediabetes or T2D will be recruited into one of a control group, or
      an exercise group. The exercising participants will begin a 16-week exercise intervention,
      targeted at achieving 150 minutes of moderate to vigorous intensity (equating to 4.5 METs)
      aerobic physical activity per week. Following the 16-week exercise program, participants will
      be randomized into two groups, each completing an additional 12 weeks of exercise. The first
      will maintain the same time and intensity, while the other will complete the 150 minutes per
      week at an intensity equal to 6.0 METs. Randomization will occur in blocks in order to ensure
      an equal number of NRs in each group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will first be randomized as controls or exercisers. All exercisers will complete a 16 week exercise program, then be randomized into two groups. The first group will increase the exercise intensity and conduct another 12 week program. The second group will continue the original program for an additional 12 weeks.
primary purpose: Prevention
masking: None (Open Label)
measure: Exercise responders following initial program
time frame: Week 17
description: The number of responders to the original 16-week exercise program, based on improvement in glycated hemoglobin
measure: Exercise responders following additional exercise program
time frame: Week 30
description: The number of responders following the additional 12-week exercise program, based on improvement in glycated hemoglobin
measure: Sex
time frame: Baseline
description: Participant self-reported biological sex
measure: Family history of cardiovascular disease
time frame: Baseline
description: Self-reported family history of cardiovascular disease
measure: Family history of cardiometabolic disease
time frame: Baseline
description: Self-reported family history of cardiometabolic disease
measure: Current medication use
time frame: Baseline
description: Record of quantity and dose of current medications
measure: Physical activity patterns
time frame: Baseline
description: Participant self-reported physical activity patterns and daily step counts over a 7-day period.
measure: Daily step count
time frame: Baseline
description: Daily step count as recorded over a 7-day period
measure: Body mass
time frame: Baseline, week 17 and week 30
description: Body mass (kilograms)
measure: Height
time frame: Baseline, week 17 and week 30
description: Height (centimetres)
measure: Waist circumference
time frame: Baseline, week 17 and week 30
description: Waist circumference (cm)
measure: Fat mass
time frame: Baseline, week 17 and week 30
description: Fat mass (kg)
measure: Fat free mass
time frame: Baseline, week 17 and week 30
description: Fat free mass (kg)
measure: Cardiorespiratory fitness
time frame: Baseline, week 17 and week 30
description: VO2 peak
measure: Body mass index
time frame: Baseline, week 17, week 30
description: Weight (kilograms) and height (measured in centimetres and converted to metres) will be combined to report body mass index in kg/m^2
arm group label: Controls
arm group type: No Intervention
description: The primary purpose of the control participants are to provide a measure of variability. They will be used in our calculations of typical error to classify participants as responders or non-responders, and to quantify inter-individual variability.
arm group label: Exercisers (Maintained)
arm group type: Experimental
description: The maintained exercise group will complete the original 16-week exercise intervention at an intensity of 4.5 metabolic equivalents (METs), and repeat the intervention for another 12-weeks following its completion.
arm group label: Exercisers (Increased Intensity)
arm group type: Experimental
description: The increased intensity exercise group will complete the original 16-week exercise intervention, followed by an additional 12 week intervention completed at an intensity of 6.0 METs.
intervention type: Behavioral
intervention name: Maintained Exercise
description: Complete 28 weeks of aerobic exercise, with one week (following week 16) for testing.
Week 1 - 16 Intensity: 4.5 metabolic equivalents (METs).
Duration:
Week 1: 80 minutes Week 2: 100 minutes Week 3: 120 minutes Week 4: 135 minutes Week 5 - 16: 150 minutes/week
Week 17: Physiological Testing
Week 18 - 29 Intensity: 4.5 METs Duration: 150 minutes/week
All exercise must be completed across a minimum of two sessions per week. Sub-maximal exercise tests will be completed every 4 weeks to adjust intensity.
arm group label: Exercisers (Maintained)
intervention type: Behavioral
intervention name: Increased Intensity
description: Complete 28 weeks of aerobic exercise, with one week (following week 16) for testing.
Week 1 - 16 Intensity: 4.5 metabolic equivalents (METs).
Duration:
Week 1: 80 minutes Week 2: 100 minutes Week 3: 120 minutes Week 4: 135 minutes Week 5 - 16: 150 minutes/week
Week 17: Physiological Testing
Week 18 - 29 Intensity: 6.0 METs Duration: 150 minutes/week
All exercise must be completed across a minimum of two sessions per week. Sub-maximal exercise tests will be completed every 4 weeks to adjust intensity.
arm group label: Exercisers (Increased Intensity)
criteria: 
gender: All
minimum age: 19 Years
maximum age: 85 Years
healthy volunteers: No
last name: Martin Senechal, PhD
role: Principal Investigator
affiliation: University of New Brunswick
facility: 
country: Canada
citation: Hecksteden A, Pitsch W, Rosenberger F, Meyer T. Repeated testing for the assessment of individual response to exercise training. J Appl Physiol (1985). 2018 Jun 1;124(6):1567-1579. doi: 10.1152/japplphysiol.00896.2017. Epub 2018 Jan 11.
PMID: 29357481
citation: Montero D, Lundby C. Refuting the myth of non-response to exercise training: 'non-responders' do respond to higher dose of training. J Physiol. 2017 Jun 1;595(11):3377-3387. doi: 10.1113/JP273480. Epub 2017 May 14. Erratum In: J Physiol. 2018 Apr 1;596(7):1311.
PMID: 28133739
citation: de Lannoy L, Clarke J, Stotz PJ, Ross R. Effects of intensity and amount of exercise on measures of insulin and glucose: Analysis of inter-individual variability. PLoS One. 2017 May 11;12(5):e0177095. doi: 10.1371/journal.pone.0177095. eCollection 2017.
PMID: 28493912
responsible party type: Principal Investigator
investigator affiliation: University of New Brunswick
investigator full name: Martin Senechal
investigator title: Assistant Professor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No