<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/NCT03827239</url>
  </required_header>
  <id_info>
    <org_study_id>6007895</org_study_id>
    <nct_id>NCT03827239</nct_id>
  </id_info>
  <brief_title>Investigation of the Effects of Sedentary Behaviour and Moderate Exercise on Glucose Tolerance and Insulin Sensitivity</brief_title>
  <official_title>Investigation of the Effects of Sedentary Behaviour and Moderate Exercise on Glucose Tolerance and Insulin Sensitivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Prince Edward Island</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Prince Edward Island</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>
      Individuals with pre-diabetes or diabetes would benefit from low impact methods that would&#xD;
      improve their insulin sensitivity and aid in maintaining glucose homeostasis. Physical&#xD;
      activity helps the body decrease its insulin resistance and burn excess sugar. Many diabetics&#xD;
      also suffer from obesity and specific forms or durations of physical exercise may not be&#xD;
      viable options for these individuals. Determining whether short bursts of moderate exercise&#xD;
      improve blood glucose levels in healthy humans may identify a further method for diabetics to&#xD;
      improve their glucose homeostasis.&#xD;
&#xD;
      The aim of this study is to determine the most effective moderate exercise that can be&#xD;
      completed in 3 minutes and its effectiveness on improving glucose handling, in response to a&#xD;
      single day of standardized high-fat and high-carbohydrate feeding in comparison to periods of&#xD;
      prolonged sitting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of funding caused us to cancel the study.&#xD;
  </why_stopped>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Insulin levels</measure>
    <time_frame>Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days</time_frame>
    <description>The change in blood insulin levels from baseline (12 hours fasted) to 3-hours post-prandial will be determined from blood serum using a human metabolic hormone multiplex panel (Luminex xMAP technology).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in concentration of C-peptide</measure>
    <time_frame>Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days</time_frame>
    <description>The change in blood C-peptide levels from baseline (12 hours fasted) to 3-hours post-prandial will be determined from blood serum using a human metabolic hormone multiplex panel (Luminex xMAP technology).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in blood glucose levels</measure>
    <time_frame>Baseline and every 30-60 minutes over 3 hours (6 timepoints per test day)</time_frame>
    <description>Blood glucose levels will be determined at pre-prandial baseline and over the following 3-hour testing period using hand-held blood glucose meters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in metabolomic response to a test meal</measure>
    <time_frame>Pre-prandial and 3-hours post test meal through study completion</time_frame>
    <description>Targeted metabolomics analysis of approximately 139 metabolites in blood serum by LC-MS/MS to generate a metabolomic profile in response to a high-fat and high-carbohydrate test meal. Metabolites to be determined are categorized as biogenic amines, amino acids, histidines, carboxylic acids, acylcarnitines, glycerophospholipids and organic acids.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immediate effects of short-term sedentary behaviour on cognitive function</measure>
    <time_frame>3 hours post-activity (sedentary behaviour or exercise) on test days through study completion</time_frame>
    <description>Assessing cognitive abilities using the Stroop Test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate effects of short-term sedentary behaviour on cognitive function</measure>
    <time_frame>3 hours post-activity (sedentary behaviour or exercise) on test days through study completion</time_frame>
    <description>Assessing cognitive abilities using the Iowa Trail Making Test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate effects of short-term sedentary behaviour on cognitive function</measure>
    <time_frame>3 hours post-activity (sedentary behaviour or exercise) on test days through study completion</time_frame>
    <description>Assessing cognitive abilities using the Digit-Span test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate effects of short-term sedentary behaviour on cognitive function</measure>
    <time_frame>3 hours post-activity (sedentary behaviour or exercise) on test days through study completion</time_frame>
    <description>Assessing cognitive abilities using the N-back test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate effects of short-term sedentary behaviour on cognitive function</measure>
    <time_frame>3 hours post-activity (sedentary behaviour or exercise) on test days through study completion</time_frame>
    <description>Assessing cognitive abilities using the Flankers test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gene expression levels in isolated PBMC populations</measure>
    <time_frame>Pre-prandial and 3 hours post-prandial on on test days through study completion</time_frame>
    <description>Determining changes in gene expression in pathways associated with RAGE signalling.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Sedentary Lifestyle</condition>
  <condition>Insulin Sensitivity</condition>
  <condition>Glucose Metabolism</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention. Study participants will be seated during the entire sedentary 3-hour time period and wheeled to phlebotomy (and exercise) stations when required. During the sedentary period, participants will eat the food according to the study protocol and be seated at desks and allowed to read and use computers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will disrupt their sedentary time with 3 minute exercise sessions every 30 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Activity/Moderate Exercise</intervention_name>
    <description>3-hour sedentary period with 3 minute activity breaks of moderate exercise every 30 minutes</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
          -  BMI between 18-30 kg/m²&#xD;
&#xD;
          -  non-smoker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  kidney disease&#xD;
&#xD;
          -  liver disease&#xD;
&#xD;
          -  cardiovascular disease&#xD;
&#xD;
          -  cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magdalena Mahlstedt, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Prince Edward Island</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Prince Edward Island</name>
      <address>
        <city>Charlottetown</city>
        <state>Prince Edward Island</state>
        <zip>C1A 4P3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2021</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>Insulin Resistance</mesh_term>
    <mesh_term>Hypersensitivity</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/NCT03827239
org study id: 6007895
nct id: NCT03827239
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Individuals with pre-diabetes or diabetes would benefit from low impact methods that would
      improve their insulin sensitivity and aid in maintaining glucose homeostasis. Physical
      activity helps the body decrease its insulin resistance and burn excess sugar. Many diabetics
      also suffer from obesity and specific forms or durations of physical exercise may not be
      viable options for these individuals. Determining whether short bursts of moderate exercise
      improve blood glucose levels in healthy humans may identify a further method for diabetics to
      improve their glucose homeostasis.

      The aim of this study is to determine the most effective moderate exercise that can be
      completed in 3 minutes and its effectiveness on improving glucose handling, in response to a
      single day of standardized high-fat and high-carbohydrate feeding in comparison to periods of
      prolonged sitting.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Insulin levels
time frame: Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days
description: The change in blood insulin levels from baseline (12 hours fasted) to 3-hours post-prandial will be determined from blood serum using a human metabolic hormone multiplex panel (Luminex xMAP technology).
measure: Change in concentration of C-peptide
time frame: Pre-prandial baseline (12 hours fasted) and 3 hours post-prandial on each of two testing days
description: The change in blood C-peptide levels from baseline (12 hours fasted) to 3-hours post-prandial will be determined from blood serum using a human metabolic hormone multiplex panel (Luminex xMAP technology).
measure: Changes in blood glucose levels
time frame: Baseline and every 30-60 minutes over 3 hours (6 timepoints per test day)
description: Blood glucose levels will be determined at pre-prandial baseline and over the following 3-hour testing period using hand-held blood glucose meters.
measure: Change in metabolomic response to a test meal
time frame: Pre-prandial and 3-hours post test meal through study completion
description: Targeted metabolomics analysis of approximately 139 metabolites in blood serum by LC-MS/MS to generate a metabolomic profile in response to a high-fat and high-carbohydrate test meal. Metabolites to be determined are categorized as biogenic amines, amino acids, histidines, carboxylic acids, acylcarnitines, glycerophospholipids and organic acids.
measure: Immediate effects of short-term sedentary behaviour on cognitive function
time frame: 3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
description: Assessing cognitive abilities using the Stroop Test.
measure: Immediate effects of short-term sedentary behaviour on cognitive function
time frame: 3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
description: Assessing cognitive abilities using the Iowa Trail Making Test.
measure: Immediate effects of short-term sedentary behaviour on cognitive function
time frame: 3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
description: Assessing cognitive abilities using the Digit-Span test.
measure: Immediate effects of short-term sedentary behaviour on cognitive function
time frame: 3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
description: Assessing cognitive abilities using the N-back test.
measure: Immediate effects of short-term sedentary behaviour on cognitive function
time frame: 3 hours post-activity (sedentary behaviour or exercise) on test days through study completion
description: Assessing cognitive abilities using the Flankers test.
measure: Gene expression levels in isolated PBMC populations
time frame: Pre-prandial and 3 hours post-prandial on on test days through study completion
description: Determining changes in gene expression in pathways associated with RAGE signalling.
arm group label: Control
arm group type: No Intervention
description: No intervention. Study participants will be seated during the entire sedentary 3-hour time period and wheeled to phlebotomy (and exercise) stations when required. During the sedentary period, participants will eat the food according to the study protocol and be seated at desks and allowed to read and use computers.
arm group label: Intervention
arm group type: Experimental
description: Will disrupt their sedentary time with 3 minute exercise sessions every 30 minutes
intervention type: Other
intervention name: Activity/Moderate Exercise
description: 3-hour sedentary period with 3 minute activity breaks of moderate exercise every 30 minutes
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Magdalena Mahlstedt, PhD
role: Study Director
affiliation: University of Prince Edward Island
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Insulin Resistance
mesh term: Hypersensitivity