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Impact of Weight Loss Following Bariatric Surgery on Pulmonary Function in Patients With Morbid Obesity

Sponsor
Laval University (Other)
Overall Status
Completed
CT.gov ID
NCT00532896
Collaborator
(none)
60
Enrollment
1
Location
61
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Increase in body mass index (BMI)is associated with a decrease in expiratory flows.Obesity is also associated with an increased prevalence of asthma.Consequences of obesity on respiratory function and on bronchial responsiveness are still to be documented.

This study aims to evaluate, before and after surgery, the impact of a bariatric surgery (biliopancreatic diversion with duodenal switch)on respiratory function in patients with morbid obesity .

Our hypothesis is that weight loss following bariatric surgery will induce significant improvements in pulmonary function and airway responsiveness, and, as a consequence, a reduction in respiratory symptoms,these changes being correlated with a reduction in systemic markers of inflammation. Maintenance of weight loss after one year will permit the persistence of these improvements

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients will be evaluated before the surgery (time zero), 6 months and one year after their surgery. A control group of patients on a waiting list for bariatric surgery will be evaluated at time zero and after 6 months and one year.

    At each visit,patients will:

    • fill a standardized respiratory questionnaire and a questionnaire on sleep apnea; questionnaires on asthma control will be completed by patients with asthma.

    • have a spirometry, pulmonary volumes measures by body plethysmography and methacholine inhalation test with evaluation of symptoms perception.

    • an induced sputum will be performed.

    • A blood sample will be drawn to evaluate inflammation and measure C-reactive protein concentration in plasma.

    • An allergy skin prick test will be done at time zero.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Weight Loss Following Bariatric Surgery on Pulmonary Function in Patients With Morbid Obesity
    Study Start Date :
    Apr 1, 2006
    Actual Primary Completion Date :
    Jan 1, 2011
    Actual Study Completion Date :
    May 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    bariatric surgery

    patients with morbid obesity undergoing a bariatric surgery
    No bariatric surgery

    patients with morbid obesity on a waiting list for a bariatric surgery but who will have their surgery in more than one year.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Body mass index >or= 35 kg/m2

      • Non-smokers or ex-smokers (<10 packs-year)

      Exclusion Criteria:

      • Previous bariatric surgery

      • previous vagotomy

      • no compliance to visits

      • subjects unable to provide an informed consent or to understand the questions included in questionnaires

      • Patients with cardiac pacemaker

      • hemodynamically significant valvulopathy

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Centre de Recherche, Hôpital Laval Québec Quebec Canada G1V 4G5

      Sponsors and Collaborators

      • Laval University

      Investigators

      • Principal Investigator: Louis-Philippe Boulet, MD, Hôpital Laval

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Louis-Philippe Boulet, MD, FRCPC, FCCP, Laval University
      ClinicalTrials.gov Identifier:
      NCT00532896
      Other Study ID Numbers:
      • HL-Ch-BAR-Pneu-20086
      First Posted:
      Sep 21, 2007
      Last Update Posted:
      Feb 22, 2012
      Last Verified:
      Feb 1, 2012
      Additional relevant MeSH terms:
      Respiration Disorders
      Respiratory Tract Diseases
      Obesity
      Obesity, Morbid
      Weight Loss

      Study Results

      No Results Posted as of Feb 22, 2012