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

NCT ID: NCT00532896

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2011-05-31

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

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.

Conditions

Bariatric Surgery; Obesity; Respiratory Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

bariatric surgery

patients with morbid obesity undergoing a bariatric surgery

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Louis-Philippe Boulet

MD, FRCPC, FCCP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louis-Philippe Boulet, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Laval

Locations

Centre de Recherche, Hôpital Laval

Québec, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 22326605 (View on PubMed)

Other Identifiers

HL-Ch-BAR-Pneu-20086

Identifier Type: -

Identifier Source: org_study_id