<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/NCT03035149</url>
  </required_header>
  <id_info>
    <org_study_id>2005213-01H</org_study_id>
    <nct_id>NCT03035149</nct_id>
  </id_info>
  <brief_title>Exercise Capacity and Dyspnea in Obese Patients With Metabolic Syndrome: Effects of Weight Loss</brief_title>
  <official_title>Exercise Capacity and Dyspnea in Obese Patients With Metabolic Syndrome: Effects of Weight Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ottawa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ontario Lung Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Ottawa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Ottawa</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>
      Dyspnea is a common complaint in obese patients. The mechanisms behind this dyspnea and the&#xD;
      effects of weight loss on dyspnea are not completely understood. The objectives of this study&#xD;
      were to examine the relationships between exercise parameters and dyspnea in obesity and&#xD;
      assess the effects of weight loss.&#xD;
&#xD;
      The investigators compared pulmonary function, exercise performance and dyspnea in 34&#xD;
      patients with abdominal obesity and metabolic syndrome (MS) against 34 age and sex-matched&#xD;
      controls. The study also assessed within-group changes in physiology and symptoms in a subset&#xD;
      of patients following participation in a weight management program.&#xD;
&#xD;
      Because obesity is a heterogeneous condition, with variable genetic associations,&#xD;
      co-morbidities and distributions of adipose tissue, the study focused on patients with&#xD;
      abdominal obesity who met diagnostic criteria for metabolic syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study has two parts: first, the investigators compared dyspnea, pulmonary function and&#xD;
      exercise measurements between obese patients and control subjects with normal weight; then,&#xD;
      the investigators assessed the effects of medical weight loss in the obese group on these&#xD;
      parameters. Baseline dyspnea was assessed using the baseline dyspnea index.The effect of&#xD;
      weight loss on dyspnea was assessed using the transitional dyspnea index. The main&#xD;
      physiologic measurement of interest was the inspiratory capacity (L, measured at rest and&#xD;
      during exercise).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2005</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dyspnea (measured by Transitional Dyspnea Index)</measure>
    <time_frame>Within 6 months following completion of 6 months (weight loss period) in the weight management program</time_frame>
    <description>Dyspnea was assessed using a questionnaire based on the Transitional Dyspnea Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resting Inspiratory Capacity (L)</measure>
    <time_frame>Within 6 months following completion of 6 months (weight loss period) in the weight management program</time_frame>
    <description>Inspiratory capacity (difference between total lung capacity and functional residual capacity), measured at rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inspiratory Capacity during Exercise (L)</measure>
    <time_frame>Within 6 months following completion of 6 month (weight loss period) in the weight management program</time_frame>
    <description>Inspiratory capacity measured at identical time points during incremental exercise tests, performed before and after weight loss</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Obesity</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Weight Management Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Obese subjects participate in a year long medically supervised weight management program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Weight Controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Normal weight age and sex-matched controls. Unlike the obese subjects, the controls did not participate in the Weight Management Program. Pulmonary function, exercise performance and dyspnea results for normal weight controls were compared against the results for obese subjects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Weight Management Program</intervention_name>
    <description>Obese subjects partake in a medically supervised weight management program. This lifestyle modification program involves weekly three hour sessions for six months and monthly sessions for six months. The first twelve weeks comprise an initial weight loss phase when patients are placed on a 900 Kcal/day meal replacement. This is followed by a four week transition to a 1200-1800 Kcal diet followed by a ten week maintenance phase of 10 weekly sessions.The majority of weight loss occurs during the first 26 weeks followed by a 26 week period of stabilization of weight loss. Hence subjects are evaluated after the first 26 weeks.</description>
    <arm_group_label>Weight Management Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals accepted into the behavioural weight management program at the Ottawa&#xD;
             Hospital Bariatric Centre&#xD;
&#xD;
          -  Age between 20 and 60 years&#xD;
&#xD;
          -  BMI greater than 30&#xD;
&#xD;
          -  Abdominal girth (for females) greater than 88 cm&#xD;
&#xD;
          -  Abdominal girth (for males) greater than 102 cm&#xD;
&#xD;
          -  Plus any two of the other criteria for Metabolic Syndrome:&#xD;
&#xD;
             i.e. Blood Pressure greater or equal to 130/85; Fasting Glucose greater or equal to&#xD;
             6.1 mmol/L&#xD;
&#xD;
          -  Controls-normal weight (NW) and sedentary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Any medical conditions which would affect exercise performance&#xD;
&#xD;
          -  Use of medications that could affect exercise performance (i.e. Beta-blockers)&#xD;
&#xD;
          -  Inability to pedal on a cycle ergometer and provide reproducible inspiratory capacity&#xD;
             (IC) measurements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nha Voduc, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ottawa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>March 2, 2018</last_update_submitted>
  <last_update_submitted_qc>March 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Ottawa</investigator_affiliation>
    <investigator_full_name>Dr. Nha Voduc</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Metabolic Syndrome</keyword>
  <keyword>Dyspnea</keyword>
  <keyword>Pulmonary Function</keyword>
  <keyword>Exercise Capacity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspnea</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Weight Loss</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/NCT03035149
org study id: 2005213-01H
nct id: NCT03035149
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Dyspnea is a common complaint in obese patients. The mechanisms behind this dyspnea and the
      effects of weight loss on dyspnea are not completely understood. The objectives of this study
      were to examine the relationships between exercise parameters and dyspnea in obesity and
      assess the effects of weight loss.

      The investigators compared pulmonary function, exercise performance and dyspnea in 34
      patients with abdominal obesity and metabolic syndrome (MS) against 34 age and sex-matched
      controls. The study also assessed within-group changes in physiology and symptoms in a subset
      of patients following participation in a weight management program.

      Because obesity is a heterogeneous condition, with variable genetic associations,
      co-morbidities and distributions of adipose tissue, the study focused on patients with
      abdominal obesity who met diagnostic criteria for metabolic syndrome.
The study has two parts: first, the investigators compared dyspnea, pulmonary function and
      exercise measurements between obese patients and control subjects with normal weight; then,
      the investigators assessed the effects of medical weight loss in the obese group on these
      parameters. Baseline dyspnea was assessed using the baseline dyspnea index.The effect of
      weight loss on dyspnea was assessed using the transitional dyspnea index. The main
      physiologic measurement of interest was the inspiratory capacity (L, measured at rest and
      during exercise).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Dyspnea (measured by Transitional Dyspnea Index)
time frame: Within 6 months following completion of 6 months (weight loss period) in the weight management program
description: Dyspnea was assessed using a questionnaire based on the Transitional Dyspnea Index
measure: Resting Inspiratory Capacity (L)
time frame: Within 6 months following completion of 6 months (weight loss period) in the weight management program
description: Inspiratory capacity (difference between total lung capacity and functional residual capacity), measured at rest
measure: Inspiratory Capacity during Exercise (L)
time frame: Within 6 months following completion of 6 month (weight loss period) in the weight management program
description: Inspiratory capacity measured at identical time points during incremental exercise tests, performed before and after weight loss
arm group label: Weight Management Program
arm group type: Experimental
description: Obese subjects participate in a year long medically supervised weight management program.
arm group label: Normal Weight Controls
arm group type: No Intervention
description: Normal weight age and sex-matched controls. Unlike the obese subjects, the controls did not participate in the Weight Management Program. Pulmonary function, exercise performance and dyspnea results for normal weight controls were compared against the results for obese subjects.
intervention type: Other
intervention name: Weight Management Program
description: Obese subjects partake in a medically supervised weight management program. This lifestyle modification program involves weekly three hour sessions for six months and monthly sessions for six months. The first twelve weeks comprise an initial weight loss phase when patients are placed on a 900 Kcal/day meal replacement. This is followed by a four week transition to a 1200-1800 Kcal diet followed by a ten week maintenance phase of 10 weekly sessions.The majority of weight loss occurs during the first 26 weeks followed by a 26 week period of stabilization of weight loss. Hence subjects are evaluated after the first 26 weeks.
arm group label: Weight Management Program
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nha Voduc, MD
role: Principal Investigator
affiliation: University of Ottawa
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Ottawa
investigator full name: Dr. Nha Voduc
investigator title: MD
mesh term: Dyspnea
mesh term: Metabolic Syndrome
mesh term: Syndrome
mesh term: Weight Loss
sharing ipd: No