<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/NCT03029936</url>
  </required_header>
  <id_info>
    <org_study_id>43599215.4.0000.5208</org_study_id>
    <nct_id>NCT03029936</nct_id>
  </id_info>
  <brief_title>Obesity-asthma Endophenotype and Diaphragm Mobility in Adolescence</brief_title>
  <official_title>Obesity-asthma Endophenotype: Assessment of Diaphragm Mobility and Muscle Inflammation Markers in the Adolescence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Pernambuco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Pernambuco</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>
      Obesity and asthma share changes that may begin in the fetal development phase. The&#xD;
      endophenotype obesity-asthma presents as main characteristic a pattern of inflammatory&#xD;
      response different from the habitual Th2 profile of cytokines. In these obese patients,&#xD;
      possible changes in the diaphragm muscle can directly influence the dynamics of pulmonary&#xD;
      ventilation significantly.&#xD;
&#xD;
      Due to the importance of the diaphragm in pulmonary ventilation, this study will be performed&#xD;
      to verify possible alteration in the excursion and diaphragmatic thickness of adolescents&#xD;
      with endophenotype obesity-asthma. In parallel, the possible underlying etiopathogenic&#xD;
      substrate of this endophenotype will be explored through the dosing of muscle enzymes and&#xD;
      inflammatory cytokines and obesity hormones.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">July 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diaphragm mobility</measure>
    <time_frame>1 day</time_frame>
    <description>Change in &quot;mm&quot; of diaphragm mobility.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diaphragm thickness</measure>
    <time_frame>1 day</time_frame>
    <description>Change in &quot;cm&quot; of diaphragm thickness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Th1 Cytokine Levels</measure>
    <time_frame>1 day</time_frame>
    <description>Change in &quot;pg/mL&quot; of Th1 Cytokines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Th2 Cytokine Levels</measure>
    <time_frame>1 day</time_frame>
    <description>Change in &quot;pg/mL&quot; of Th2 Cytokines</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Obesity</condition>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Obesity Group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Asthma Group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Obesity-Asthma Group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        108 adolescents aged 12 years to 21 years will be recruited, of all sexes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents of both sexes, aged 12-21 years;&#xD;
&#xD;
          -  For the obesity groups, BMI for gender and age equal to or greater than the 97th&#xD;
             percentile;&#xD;
&#xD;
          -  Clinical diagnosis of persistent, moderate and severe asthma by a specialist physician&#xD;
             and its severity classified according to the GINA (Global Initiative Against Asthma)&#xD;
             criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adolescents with a diagnosis of cardiovascular, rheumatic, osteoarticular,&#xD;
             neuromuscular or any other disease that limits the safe performance of the tests&#xD;
             proposed by the protocol will be excluded; And those who do not agree to participate&#xD;
             in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis H Tenório, MsC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal de Pernambuco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Federal de Pernambuco</name>
      <address>
        <city>Recife</city>
        <state>Pernambuco</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>March 16, 2018</last_update_submitted>
  <last_update_submitted_qc>March 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Pernambuco</investigator_affiliation>
    <investigator_full_name>Lui-s Henrique Sarmento Tenorio</investigator_full_name>
    <investigator_title>Principal Investgator</investigator_title>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>asthma</keyword>
  <keyword>diaphragm excursion</keyword>
  <keyword>pulmonary function test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>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/NCT03029936
org study id: 43599215.4.0000.5208
nct id: NCT03029936
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obesity and asthma share changes that may begin in the fetal development phase. The
      endophenotype obesity-asthma presents as main characteristic a pattern of inflammatory
      response different from the habitual Th2 profile of cytokines. In these obese patients,
      possible changes in the diaphragm muscle can directly influence the dynamics of pulmonary
      ventilation significantly.

      Due to the importance of the diaphragm in pulmonary ventilation, this study will be performed
      to verify possible alteration in the excursion and diaphragmatic thickness of adolescents
      with endophenotype obesity-asthma. In parallel, the possible underlying etiopathogenic
      substrate of this endophenotype will be explored through the dosing of muscle enzymes and
      inflammatory cytokines and obesity hormones.
observational model: Other
time perspective: Cross-Sectional
measure: Diaphragm mobility
time frame: 1 day
description: Change in "mm" of diaphragm mobility.
measure: Diaphragm thickness
time frame: 1 day
description: Change in "cm" of diaphragm thickness.
measure: Th1 Cytokine Levels
time frame: 1 day
description: Change in "pg/mL" of Th1 Cytokines
measure: Th2 Cytokine Levels
time frame: 1 day
description: Change in "pg/mL" of Th2 Cytokines
arm group label: Obesity Group
arm group label: Asthma Group
arm group label: Obesity-Asthma Group
arm group label: Control
Serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luis H Tenório, MsC
role: Principal Investigator
affiliation: Universidade Federal de Pernambuco
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Pernambuco
investigator full name: Lui-s Henrique Sarmento Tenorio
investigator title: Principal Investgator
mesh term: Asthma
mesh term: Obesity
sharing ipd: No