<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/NCT02207192</url>
  </required_header>
  <id_info>
    <org_study_id>FRC obesity</org_study_id>
    <nct_id>NCT02207192</nct_id>
  </id_info>
  <brief_title>Postural Changes in Lung Volumes in Obesity</brief_title>
  <official_title>Effect of Weight Loss on Postural Changes in Pulmonary Function : a Longitudinal Study in Morbidly Obese to Obese Subjects Following Gastroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association pour la Formation du Personnel à la Medecine d'Urgence</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Association pour la Formation du Personnel à la Medecine d'Urgence</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postural changes are known to affect normal lung volumes. A reduction in sitting to supine&#xD;
      functional residual capacity (FRC) is well-described in non-obese subjects adopting a supine&#xD;
      position. However, postural changes in lung volumes in the obese require further exploration.&#xD;
      We aimed to longitudinally address the effects of weight loss on postural changes in lung&#xD;
      volumes and pulmonary function, in obesity. We tested the hypothesis that supine reduction in&#xD;
      FRC would be absent in morbid obesity and recovered upon weight loss.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2005</start_date>
  <completion_date type="Actual">October 2008</completion_date>
  <primary_completion_date type="Actual">October 2008</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>functional residual capacity</measure>
    <time_frame>baseline and one year after bariatric surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>lung volumes and flows</measure>
    <time_frame>at baseline and after bariatric surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Morbidly obese</arm_group_label>
    <description>Consecutive morbidly obese adults (BMI over or equal to 40 kg/m2) scheduled for bariatric surgery were prospectively recruited.Subjects with respiratory and cardiac history (asthma, Chronic obstructive pulmonary disease, heart failure) were excluded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Postural change in lung volumes: sitting to Supine</intervention_name>
    <description>Pulmonary function and arterial blood gases were assessed both prior to and after weight loss as part of pre-operative and 12-month follow-up evaluations.&#xD;
Pulmonary function tests were performed both in the sitting and then in the supine position.</description>
    <arm_group_label>Morbidly obese</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Twelve morbidly obese adults (BMI over or equal to 40 kg/m2) scheduled for bariatric&#xD;
        surgery at the Montpellier university hospital were recruited. They were 3 men and 9 women.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects scheduled for bariatric surgery (BMI over or equal to 40 kg/m2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with respiratory and cardiac history (asthma, COPD, heart failure) were&#xD;
             excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mustapha Sebbane, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montpellier University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montpellier University hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obesity, lung volumes, postural changes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT02207192
org study id: FRC obesity
nct id: NCT02207192
lead sponsor: 
has dmc: No
Postural changes are known to affect normal lung volumes. A reduction in sitting to supine
      functional residual capacity (FRC) is well-described in non-obese subjects adopting a supine
      position. However, postural changes in lung volumes in the obese require further exploration.
      We aimed to longitudinally address the effects of weight loss on postural changes in lung
      volumes and pulmonary function, in obesity. We tested the hypothesis that supine reduction in
      FRC would be absent in morbid obesity and recovered upon weight loss.
observational model: Case-Crossover
time perspective: Prospective
measure: functional residual capacity
time frame: baseline and one year after bariatric surgery
measure: lung volumes and flows
time frame: at baseline and after bariatric surgery
arm group label: Morbidly obese
description: Consecutive morbidly obese adults (BMI over or equal to 40 kg/m2) scheduled for bariatric surgery were prospectively recruited.Subjects with respiratory and cardiac history (asthma, Chronic obstructive pulmonary disease, heart failure) were excluded.
intervention type: Other
intervention name: Postural change in lung volumes: sitting to Supine
description: Pulmonary function and arterial blood gases were assessed both prior to and after weight loss as part of pre-operative and 12-month follow-up evaluations.
Pulmonary function tests were performed both in the sitting and then in the supine position.
arm group label: Morbidly obese
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 60 Years
healthy volunteers: No
last name: Mustapha Sebbane, MD, PhD
role: Principal Investigator
affiliation: Montpellier University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Obesity