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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
History of Changes
  Purpose

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
Bariatric Surgery
Obesity
Respiratory Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Weight Loss Following Bariatric Surgery on Pulmonary Function in Patients With Morbid Obesity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laval University:

Biospecimen Retention:   Samples Without DNA

serum plasma


Enrollment: 60
Study Start Date: April 2006
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532896

Locations
Canada, Quebec
Centre de Recherche, Hôpital Laval
Québec, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: Louis-Philippe Boulet, MD Hôpital Laval
  More Information

No publications provided by Laval University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Louis-Philippe Boulet, MD, FRCPC, FCCP, Laval University
ClinicalTrials.gov Identifier: NCT00532896     History of Changes
Other Study ID Numbers: HL-Ch-BAR-Pneu-20086
Study First Received: September 19, 2007
Last Updated: February 20, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Respiration Disorders
Respiratory Tract Diseases
Weight Loss
Overnutrition
 Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 16, 2013