Impact of Weight Loss Following Bariatric Surgery on Pulm... | NCT00532896

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

NCT00532896

Sponsor

Laval University

Status

Completed

Last Update Posted

Feb 22, 2012Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Bariatric Surgery
Obesity
Respiratory Diseases

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Jan 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Sep 19, 2007

First Submission Date that Met QC Criteria

Sep 19, 2007

First Posted Date

Sep 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2012

Last Update Posted Date

Feb 22, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Louis-Philippe Boulet, MD	Hôpital Laval	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre de Recherche, Hôpital Laval		Québec	Quebec	G1V 4G5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22326605	Derived	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.

ID	Term
D009765	Obesity
D012140	Respiratory Tract Diseases

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases