- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Quebec
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Québec, Quebec, 캐나다, G1V 4G5
- Centre de Recherche, Hôpital Laval
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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bariatric surgery
patients with morbid obesity undergoing a bariatric surgery
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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.
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .