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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Louis-Philippe Boulet, Laval University
ClinicalTrials.gov Identifier:
NCT00532896
First received: September 19, 2007
Last updated: February 20, 2012
Last verified: February 2012

September 19, 2007
February 20, 2012
April 2006
January 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00532896 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Impact of Weight Loss Following Bariatric Surgery on Pulmonary Function in Patients With Morbid Obesity
Impact of Weight Loss Following Bariatric Surgery on Pulmonary Function in Patients With Morbid Obesity

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

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum plasma

Non-Probability Sample

Subjects on the waiting list for bariatric surgery at Laval Hospital will be offered to participate to the study.

  • Bariatric Surgery
  • Obesity
  • Respiratory Diseases
Not Provided
  • 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.
Boulet LP, Turcotte H, Martin J, Poirier P. Effect of bariatric surgery on airway response and lung function in obese subjects with asthma. Respir Med. 2012 May;106(5):651-60. doi: 10.1016/j.rmed.2011.12.012. Epub 2012 Feb 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00532896
HL-Ch-BAR-Pneu-20086
No
Louis-Philippe Boulet, Laval University
Laval University
Not Provided
Principal Investigator: Louis-Philippe Boulet, MD Hôpital Laval
Laval University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP