<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/NCT03003754</url>
  </required_header>
  <id_info>
    <org_study_id>2016-12-22</org_study_id>
    <nct_id>NCT03003754</nct_id>
  </id_info>
  <brief_title>Supervised Exercise-training in Children With Insulin Resistance or Healthy Metabolic Profile</brief_title>
  <official_title>Supervised Exercise-training in Children With Insulin Resistance or Healthy Metabolic Profile: Cardiometabolic Risk Factors and Muscular Strength Changes in Responders and Non Responders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Santo Tomas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Healthcare Center Tomas Rojas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Health Service of Los Ríos by the Health promotion program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad Pública de Navarra</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad del Rosario</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Santo Tomas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite exercise training decrease blood fasting glycemia in 'average' terms, there is a wide&#xD;
      interindividual variability after exercise training explored mainly in adults but not in&#xD;
      children. Thus, is yet unknown what baseline health status as well as the influence of what&#xD;
      health variable may produce more/less non-responder (NR) prevalence (i.e., percentage of&#xD;
      subjects who experienced a non-change/worsened response after training in some metabolic&#xD;
      outcomes) after exercise training in school children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in plasma homeostasis model assessment (HOMA-IR)</measure>
    <time_frame>Baseline and 6 weeks immediately after the interventions ends</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in body mass</measure>
    <time_frame>Baseline and 6 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in body mass index</measure>
    <time_frame>Baseline and 6 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in waist circumference</measure>
    <time_frame>Baseline and 6 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in fat mass</measure>
    <time_frame>Baseline and 6 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in blood pressure</measure>
    <time_frame>Baseline and 6 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in fasting glucose</measure>
    <time_frame>Baseline and 6 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in fasting insulin</measure>
    <time_frame>Baseline and 6 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in one maximum repetition strength test of leg-extension exercise</measure>
    <time_frame>Baseline and 6 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in one maximum repetition strength test of shoulder press exercise</measure>
    <time_frame>Baseline and 6 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in one maximum repetition strength test of upper-row exercise</measure>
    <time_frame>Baseline and 6 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in one maximum repetition strength test of biceps curl exercise</measure>
    <time_frame>Baseline and 6 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Metabolism Disorder</condition>
  <condition>Insulin Sensitivity</condition>
  <condition>Obesity, Pediatric</condition>
  <arm_group>
    <arm_group_label>High Intensity Training (HIT) + Resistance Training (RT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To HIT program will be use cycle ergometers adapted for children (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) were used. Each participant performed a range of 8 to 14 cycling intervals during the intervention period. The time of each work interval cycling will be increased progressively weekly, and ranged between 40-60 s (40 s weeks 1-2; 50 s weeks 3-5; 60 s week 6), with 120 s of passive rest (over the bicycle without movement) between each interval of work.&#xD;
The RT will consist in voluntary concentric/eccentric exercise during 1 minute until to get a high subjective effort perception (i.e., between 8-10 points based on the modified and subjective Borg scale of 1 to 10 points. Subjects will perform 4 exercises (biceps curl, leg-extension, shoulders press, and upper row exercise) during 6-weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We will compare within each group (G)-1, G-2, and G-3 sub-group according to both RT and HIT intervention both pre-post changes as well as if are there some anthropometric, cardiovascular, and performance variable predicting changes in homeostasis model assessment (HOMA-IR).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High Intensity Training (HIT) + Resistance Training (RT)</intervention_name>
    <description>Exercise will be performed at three sessions per week. Post statistical analyses will be including analyses by the 3 sub-groups proposed. All sessions will be supervised by an exercise physiologist during 6 weeks.</description>
    <arm_group_label>High Intensity Training (HIT) + Resistance Training (RT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Post statistical analyses will be including analyses by the 3 sub-groups proposed Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 6 weeks.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed of insulin resistance by one of three plasmatic glucose control: HOMA-IR&#xD;
             ≥3.0,&#xD;
&#xD;
          -  Fasting insulin levels ≥15 µUI/dL or fasting glucose ≥100 and ≤126 mg/dL within the&#xD;
             enrolment stage applied at school (i.e., ≤3 months),&#xD;
&#xD;
          -  Physical inactivity (volume of ≤60 min/day of moderate physical activity),&#xD;
&#xD;
          -  To be participating of regular practical physical education classes at school (i.e.,&#xD;
             90 min/week),&#xD;
&#xD;
          -  Living only in urban areas.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Potential medical, musculoskeletal problems or a familial history of T2DM,&#xD;
&#xD;
          -  Ischemic disease,&#xD;
&#xD;
          -  Arrhythmia,&#xD;
&#xD;
          -  Asthma,&#xD;
&#xD;
          -  Utilization of drugs that modulate the metabolic and respiratory control.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Robinson Ramírez-Vélez</name>
      <address>
        <city>Bogota Distrito Especial</city>
        <state>Cundinamarca</state>
        <zip>000000000</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2018</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>Metabolic Diseases</mesh_term>
    <mesh_term>Pediatric Obesity</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/NCT03003754
org study id: 2016-12-22
nct id: NCT03003754
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Despite exercise training decrease blood fasting glycemia in 'average' terms, there is a wide
      interindividual variability after exercise training explored mainly in adults but not in
      children. Thus, is yet unknown what baseline health status as well as the influence of what
      health variable may produce more/less non-responder (NR) prevalence (i.e., percentage of
      subjects who experienced a non-change/worsened response after training in some metabolic
      outcomes) after exercise training in school children.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change from Baseline in plasma homeostasis model assessment (HOMA-IR)
time frame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in body mass
time frame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in body mass index
time frame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in waist circumference
time frame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in fat mass
time frame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in blood pressure
time frame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in fasting glucose
time frame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in fasting insulin
time frame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in one maximum repetition strength test of leg-extension exercise
time frame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in one maximum repetition strength test of shoulder press exercise
time frame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in one maximum repetition strength test of upper-row exercise
time frame: Baseline and 6 weeks immediately after the interventions ends
measure: Change from Baseline in one maximum repetition strength test of biceps curl exercise
time frame: Baseline and 6 weeks immediately after the interventions ends
arm group label: High Intensity Training (HIT) + Resistance Training (RT)
arm group type: Experimental
description: To HIT program will be use cycle ergometers adapted for children (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) were used. Each participant performed a range of 8 to 14 cycling intervals during the intervention period. The time of each work interval cycling will be increased progressively weekly, and ranged between 40-60 s (40 s weeks 1-2; 50 s weeks 3-5; 60 s week 6), with 120 s of passive rest (over the bicycle without movement) between each interval of work.
The RT will consist in voluntary concentric/eccentric exercise during 1 minute until to get a high subjective effort perception (i.e., between 8-10 points based on the modified and subjective Borg scale of 1 to 10 points. Subjects will perform 4 exercises (biceps curl, leg-extension, shoulders press, and upper row exercise) during 6-weeks.
arm group label: Control group
arm group type: Active Comparator
description: We will compare within each group (G)-1, G-2, and G-3 sub-group according to both RT and HIT intervention both pre-post changes as well as if are there some anthropometric, cardiovascular, and performance variable predicting changes in homeostasis model assessment (HOMA-IR).
intervention type: Behavioral
intervention name: High Intensity Training (HIT) + Resistance Training (RT)
description: Exercise will be performed at three sessions per week. Post statistical analyses will be including analyses by the 3 sub-groups proposed. All sessions will be supervised by an exercise physiologist during 6 weeks.
arm group label: High Intensity Training (HIT) + Resistance Training (RT)
intervention type: Behavioral
intervention name: Control group
description: Post statistical analyses will be including analyses by the 3 sub-groups proposed Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 6 weeks.
arm group label: Control group
criteria: 
gender: All
minimum age: 9 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Colombia
responsible party type: Sponsor
mesh term: Insulin Resistance
mesh term: Metabolic Diseases
mesh term: Pediatric Obesity
sharing ipd: No