- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00532896
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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
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Quebec
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Québec, Quebec, Canada, G1V 4G5
- Centre de Recherche, Hôpital Laval
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
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.
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HL-Ch-BAR-Pneu-20086
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