<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/NCT03042234</url>
  </required_header>
  <id_info>
    <org_study_id>japarecido</org_study_id>
    <secondary_id>34634414.5.0000.5479</secondary_id>
    <secondary_id>1.227.250</secondary_id>
    <nct_id>NCT03042234</nct_id>
  </id_info>
  <brief_title>HIT in Insulin-resistant and Insulin-sensitive Obese Adolescents</brief_title>
  <official_title>Effects of High-intensity Interval Training on Cardiorespiratory Performance and Substrate Oxidation in Insulin-resistant and Insulin-sensitive Obese Adolescents: A Before-and-after Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Faculdade de Ciências Médicas da Santa Casa de São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Faculdade de Ciências Médicas da Santa Casa de São Paulo</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Evaluate the effects of HIT on the cardiorespiratory performance and substrate oxidation of&#xD;
      insulin-resistant and insulin-sensitive obese adolescents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To evaluate the effect of high-intensity interval training (HIT) on the&#xD;
      cardiorespiratory performance and substrate oxidation pattern in insulin-resistant and&#xD;
      insulin-sensitive obese adolescents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2017</start_date>
  <completion_date type="Actual">November 2, 2018</completion_date>
  <primary_completion_date type="Actual">August 30, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>rate of Peak oxygen consumption (VOpeak)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The cardiopulmonary test protocol for determination the VOpeak (ml/kg/min) included running on a treadmill (Model ATL, Inbrasport Ltda; Brazil) at a speed of 4 km/h with 1 km/h increments every minute until the participant showed exhaustion.&#xD;
We evaluated ventilatory parameters on a gas analyzer (model VO2000; Inbrasport Ltda; Brazil).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>rate of Intensity at first ventilatory anaerobic threshold (VAT1)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The cardiopulmonary test protocol included running on a treadmill (Model ATL, Inbrasport Ltda; Brazil) at a speed of 4 km/h with 1 km/h increments every minute until the participant showed exhaustion.&#xD;
We evaluated ventilatory parameters on a gas analyzer (model VO2000; Inbrasport Ltda; Brazil).We determined VAT1 (ml/kg/min) using the V-slope method of Beaver et al.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>rate of Peak Heart rate</measure>
    <time_frame>4 weeks</time_frame>
    <description>The cardiopulmonary test protocol included treadmill running (Model ATL, Inbrasport Ltda; Brazil). speed of 4 km / h with increments of 1 km / h every minute until the participant shows exhaustion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>rate of carbohydrate oxidation</measure>
    <time_frame>4 weeks</time_frame>
    <description>The substrate oxidation pattern protocol included treadmill running (Model ATL, Inbrasport Ltda; Brazil),during continuous exercise of submaximal intensity (45 minutes of treadmill running at the intensity of the first ventilatory anaerobic threshold).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>rate of lipid oxidation</measure>
    <time_frame>4 weeks</time_frame>
    <description>The substrate oxidation pattern protocol included treadmill running (Model ATL, Inbrasport Ltda; Brazil),during continuous exercise of submaximal intensity (45 minutes of treadmill running at the intensity of the first ventilatory anaerobic threshold).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Obesity</condition>
  <condition>Insulin-resistant</condition>
  <condition>Adolescents</condition>
  <arm_group>
    <arm_group_label>Group Insulin-resistant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insulin-resistant obese adolescents</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Insulin-sensitive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insulin-sensitive obese adolescents</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group Insulin-Resistant</intervention_name>
    <description>High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.</description>
    <arm_group_label>Group Insulin-resistant</arm_group_label>
    <arm_group_label>Group Insulin-sensitive</arm_group_label>
    <other_name>Insulin-resistant obese adolescents</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group Insulin-Sensitive</intervention_name>
    <description>High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.</description>
    <arm_group_label>Group Insulin-resistant</arm_group_label>
    <arm_group_label>Group Insulin-sensitive</arm_group_label>
    <other_name>Insulin-sensitive obese adolescents</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Criteria&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 12-16 years&#xD;
&#xD;
          -  with a body mass index z-score (zBMI) ≥ + 2SD&#xD;
&#xD;
          -  puberty stage &gt; 3&#xD;
&#xD;
          -  the boys and girls had to present a minimum physical fitness, according to the&#xD;
             International Physical Activity Questionnaire (IPAQ), according to the activity&#xD;
             performed during the last week and confirmed this using the peak cardiopulmonary test&#xD;
             (VO2).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  individuals undergoing drug treatment for weight control;&#xD;
&#xD;
          -  indiviudals who had cardiac, orthopedic, respiratory or renal problems, diabetes,&#xD;
             uncontrolled hypertension, genetic syndrome or hormonal abnormalities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juliana Monique Lino Aparecido</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculdade de Ciências Médicas da Santa Casa de São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Santa Casa of Sao Paulo School</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01221-020</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emef Angelina Maffei Vita</name>
      <address>
        <city>Sao Paulo</city>
        <zip>02545-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emef Plinio Queroz</name>
      <address>
        <city>São Paulo</city>
        <zip>08341-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>ROSSETTI, MB; BRITO, RR; NORTON, RC. Prevenção primária de doenças cardiovasculares na obesidade infatojuvenil: efeito anti-inflamatório do exercício físico. Rev Bras Med Esporte. 2009</citation>
  </reference>
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    <citation>KLOSTER, R &amp; LIBERALI, R. Emagrecimento: composição da dieta e exercício físico. Rev Bras Nutr Esportiva. 2012 set-out; 11(2):288-306</citation>
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    <PMID>19002708</PMID>
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    <citation>MARQUEZI, ML. Adaptações decorrentes do exercício cardiorrespiratório sobre a oxidação de lipídeos: exercício aeróbio. Rev Mackenzie de Educação Física e Esporte. 2010; 9(1):32-35.</citation>
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  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>July 11, 2021</last_update_submitted>
  <last_update_submitted_qc>July 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Faculdade de Ciências Médicas da Santa Casa de São Paulo</investigator_affiliation>
    <investigator_full_name>JULIANA MONIQUE LINO</investigator_full_name>
    <investigator_title>Principal investigator Juliana Monique Lino Aparecido</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Insulin-resistant</keyword>
  <keyword>Adolescents</keyword>
  <keyword>High-intensity interval training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
  </intervention_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/NCT03042234
org study id: japarecido
secondary id: 34634414.5.0000.5479
secondary id: 1.227.250
nct id: NCT03042234
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluate the effects of HIT on the cardiorespiratory performance and substrate oxidation of
      insulin-resistant and insulin-sensitive obese adolescents.
Objective: To evaluate the effect of high-intensity interval training (HIT) on the
      cardiorespiratory performance and substrate oxidation pattern in insulin-resistant and
      insulin-sensitive obese adolescents.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: rate of Peak oxygen consumption (VOpeak)
time frame: 4 weeks
description: The cardiopulmonary test protocol for determination the VOpeak (ml/kg/min) included running on a treadmill (Model ATL, Inbrasport Ltda; Brazil) at a speed of 4 km/h with 1 km/h increments every minute until the participant showed exhaustion.
We evaluated ventilatory parameters on a gas analyzer (model VO2000; Inbrasport Ltda; Brazil).
measure: rate of Intensity at first ventilatory anaerobic threshold (VAT1)
time frame: 4 weeks
description: The cardiopulmonary test protocol included running on a treadmill (Model ATL, Inbrasport Ltda; Brazil) at a speed of 4 km/h with 1 km/h increments every minute until the participant showed exhaustion.
We evaluated ventilatory parameters on a gas analyzer (model VO2000; Inbrasport Ltda; Brazil).We determined VAT1 (ml/kg/min) using the V-slope method of Beaver et al.
measure: rate of Peak Heart rate
time frame: 4 weeks
description: The cardiopulmonary test protocol included treadmill running (Model ATL, Inbrasport Ltda; Brazil). speed of 4 km / h with increments of 1 km / h every minute until the participant shows exhaustion.
measure: rate of carbohydrate oxidation
time frame: 4 weeks
description: The substrate oxidation pattern protocol included treadmill running (Model ATL, Inbrasport Ltda; Brazil),during continuous exercise of submaximal intensity (45 minutes of treadmill running at the intensity of the first ventilatory anaerobic threshold).
measure: rate of lipid oxidation
time frame: 4 weeks
description: The substrate oxidation pattern protocol included treadmill running (Model ATL, Inbrasport Ltda; Brazil),during continuous exercise of submaximal intensity (45 minutes of treadmill running at the intensity of the first ventilatory anaerobic threshold).
arm group label: Group Insulin-resistant
arm group type: Experimental
description: Insulin-resistant obese adolescents
arm group label: Group Insulin-sensitive
arm group type: Experimental
description: Insulin-sensitive obese adolescents
intervention type: Other
intervention name: Group Insulin-Resistant
description: High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.
arm group label: Group Insulin-resistant
arm group label: Group Insulin-sensitive
other name: Insulin-resistant obese adolescents
intervention type: Other
intervention name: Group Insulin-Sensitive
description: High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.
arm group label: Group Insulin-resistant
arm group label: Group Insulin-sensitive
other name: Insulin-sensitive obese adolescents
criteria: 
gender: All
minimum age: 12 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Juliana Monique Lino Aparecido
role: Principal Investigator
affiliation: Faculdade de Ciências Médicas da Santa Casa de São Paulo
facility: 
facility: 
facility: 
country: Brazil
citation: ROSSETTI, MB; BRITO, RR; NORTON, RC. Prevenção primária de doenças cardiovasculares na obesidade infatojuvenil: efeito anti-inflamatório do exercício físico. Rev Bras Med Esporte. 2009
citation: Corte de Araujo AC, Roschel H, Picanco AR, do Prado DM, Villares SM, de Sa Pinto AL, Gualano B. Similar health benefits of endurance and high-intensity interval training in obese children. PLoS One. 2012;7(8):e42747. doi: 10.1371/journal.pone.0042747. Epub 2012 Aug 6.
PMID: 22880097
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responsible party type: Principal Investigator
investigator affiliation: Faculdade de Ciências Médicas da Santa Casa de São Paulo
investigator full name: JULIANA MONIQUE LINO
investigator title: Principal investigator Juliana Monique Lino Aparecido
mesh term: Obesity
mesh term: Insulin
mesh term: Insulin, Globin Zinc