<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/NCT02204670</url>
  </required_header>
  <id_info>
    <org_study_id>B2014:064</org_study_id>
    <nct_id>NCT02204670</nct_id>
  </id_info>
  <brief_title>EXIT: Prospective Study of the Response to Exercise</brief_title>
  <acronym>EXIT</acronym>
  <official_title>Exercise and Irisin Trial (EXIT): Prospective Cohort Study of the Determinants of the Metabolic Response to Exercise in Obese Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background :&#xD;
&#xD;
      Regular exercise is a cornerstone in the prevention and the management of comorbidities.&#xD;
      Unfortunately, the metabolic benefit of exercise training is not universal and varies among&#xD;
      individuals. A main factor likely to explain the exercise training variability is the lack of&#xD;
      empirical evidence on the determinants of exercise training. A series of muscle-derived&#xD;
      cytokines have recently been discovered that (1) are released during exercise and (2) exert&#xD;
      positive effects on peripheral tissues. Irisin is one of these novel &quot;myokines&quot; and might&#xD;
      contributes to the metabolic adaptations to exercise training.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The investigators will perform a pilot cohort study in which obese adolescents will perform&#xD;
      resistance exercise training for 6 weeks. The main exposure variable will be the acute&#xD;
      release of irisin during resistance exercise. The main outcome measures will be the change in&#xD;
      hepatic triglyceride content and glucose area under the curve during a 75g, 2-hour oral&#xD;
      glucose tolerance test.&#xD;
&#xD;
      Study Hypothesis:&#xD;
&#xD;
      The primary overall hypothesis is that the change in plasma Irisin with a single bout of&#xD;
      exercise will be associated with the metabolic adaptations to 6 weeks of resistance training,&#xD;
      specifically, the reductions in hepatic triglyceride content and post-prandial glucose&#xD;
      excursions, in obese adolescents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hepatic Triglyceride Content</measure>
    <time_frame>6 weeks</time_frame>
    <description>Hepatic triglyceride content will be measured by using 1H magnetic resonance spectroscopy. After image acquisition, a single voxel volume of interest will be placed in the upper right lobe of the liver in an area devoid of adipose tissue to acquire 1H spectra. A total of 64 spectra will be collected and averaged to determine the intracellular triglyceride content.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-prandial glucose</measure>
    <time_frame>6 weeks</time_frame>
    <description>Glucose area under the curve (AUC) will be determined by summing the area under serum glucose measures between each 15- or 30-min segment using the trapezium rule during a frequently sampled 75-g oral glucose challenge .</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Liver Fat</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Overweight Adolescents Performing Resistance Training</arm_group_label>
    <description>Overweight adolescents that meet pre-specified enrollment criteria will all undergo supervised resistance exercise for a 6-week period. Prior to training, all participants will undergo a single bout of resistance training to determine the acute release of Irisin with resistance training. This will be the primary exposure variable. After the acute session, all participants will perform resistance training three times per week for a period of 4 weeks. During each session participants will perform 3 sets of 8-12 repetitions (60-85% of 1RM) for major muscle groups (quadriceps, shoulders, and pectoral).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acute release of irisin after a single exercise session.</intervention_name>
    <description>We will determine the amount of Irisin secreted after a single bout of resistance exercise. Participants will be stratified into 3 groups based on the degree of Irisin release during this acute bout of resistance exercise. The metabolic adaptations to the 4 weeks of resistance training will be compared between youth stratified according to the amount of Irisin released during the acute bout of resistance exercise.</description>
    <arm_group_label>Overweight Adolescents Performing Resistance Training</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A community-based convenient sample of overweight adolescents aged 12-18 years with a BMI &gt;&#xD;
        95th centile for age and sex.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adolescents (12-18 years)&#xD;
&#xD;
          2. Body mass index considered obese according to the International Obesity Task Force&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Adolescents with medication-induced or type 1 diabetes&#xD;
&#xD;
          2. are currently being treated with corticosteroids or atypical antipsychotics, as these&#xD;
             agents significantly influence carbohydrate metabolism&#xD;
&#xD;
          3. have an orthopaedic injury or chronic illness that would prevent them from performing&#xD;
             the intervention&#xD;
&#xD;
          4. have experienced &gt;10% weight loss or enrolled in weight loss program within six months&#xD;
             of enrolment&#xD;
&#xD;
          5. a history of alcoholism or drug abuse&#xD;
&#xD;
          6. require use of medication(s) known to affect insulin sensitivity or secretion within&#xD;
             the last 30 days&#xD;
&#xD;
          7. medication(s) known to cause weight gain&#xD;
&#xD;
          8. anabolic steroids&#xD;
&#xD;
          9. weight loss medication(s)&#xD;
&#xD;
         10. pregnant or planning to be pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jon M McGavock, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Manitoba Institute of Child Health</name>
      <address>
        <city>Winnipeg</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>March 29, 2016</last_update_submitted>
  <last_update_submitted_qc>March 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manitoba</investigator_affiliation>
    <investigator_full_name>Jon McGavock</investigator_full_name>
    <investigator_title>Associate Professor Department of Pediatrics and Child Health</investigator_title>
  </responsible_party>
  <keyword>Irisin</keyword>
  <keyword>Obesity</keyword>
  <keyword>Exercise</keyword>
  <keyword>Myokine</keyword>
  <keyword>Impaired Glucose Tolerance</keyword>
  <!-- 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/NCT02204670
org study id: B2014:064
nct id: NCT02204670
lead sponsor: 
has dmc: No
Background :

      Regular exercise is a cornerstone in the prevention and the management of comorbidities.
      Unfortunately, the metabolic benefit of exercise training is not universal and varies among
      individuals. A main factor likely to explain the exercise training variability is the lack of
      empirical evidence on the determinants of exercise training. A series of muscle-derived
      cytokines have recently been discovered that (1) are released during exercise and (2) exert
      positive effects on peripheral tissues. Irisin is one of these novel "myokines" and might
      contributes to the metabolic adaptations to exercise training.

      Methods:

      The investigators will perform a pilot cohort study in which obese adolescents will perform
      resistance exercise training for 6 weeks. The main exposure variable will be the acute
      release of irisin during resistance exercise. The main outcome measures will be the change in
      hepatic triglyceride content and glucose area under the curve during a 75g, 2-hour oral
      glucose tolerance test.

      Study Hypothesis:

      The primary overall hypothesis is that the change in plasma Irisin with a single bout of
      exercise will be associated with the metabolic adaptations to 6 weeks of resistance training,
      specifically, the reductions in hepatic triglyceride content and post-prandial glucose
      excursions, in obese adolescents.
observational model: Cohort
time perspective: Prospective
measure: Hepatic Triglyceride Content
time frame: 6 weeks
description: Hepatic triglyceride content will be measured by using 1H magnetic resonance spectroscopy. After image acquisition, a single voxel volume of interest will be placed in the upper right lobe of the liver in an area devoid of adipose tissue to acquire 1H spectra. A total of 64 spectra will be collected and averaged to determine the intracellular triglyceride content.
measure: Post-prandial glucose
time frame: 6 weeks
description: Glucose area under the curve (AUC) will be determined by summing the area under serum glucose measures between each 15- or 30-min segment using the trapezium rule during a frequently sampled 75-g oral glucose challenge .
arm group label: Overweight Adolescents Performing Resistance Training
description: Overweight adolescents that meet pre-specified enrollment criteria will all undergo supervised resistance exercise for a 6-week period. Prior to training, all participants will undergo a single bout of resistance training to determine the acute release of Irisin with resistance training. This will be the primary exposure variable. After the acute session, all participants will perform resistance training three times per week for a period of 4 weeks. During each session participants will perform 3 sets of 8-12 repetitions (60-85% of 1RM) for major muscle groups (quadriceps, shoulders, and pectoral).
intervention type: Other
intervention name: Acute release of irisin after a single exercise session.
description: We will determine the amount of Irisin secreted after a single bout of resistance exercise. Participants will be stratified into 3 groups based on the degree of Irisin release during this acute bout of resistance exercise. The metabolic adaptations to the 4 weeks of resistance training will be compared between youth stratified according to the amount of Irisin released during the acute bout of resistance exercise.
arm group label: Overweight Adolescents Performing Resistance Training
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jon M McGavock, PhD
role: Principal Investigator
affiliation: University of Manitoba
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Manitoba
investigator full name: Jon McGavock
investigator title: Associate Professor Department of Pediatrics and Child Health