The Impact of Bariatric Surgery Induced Weight Loss on Lung Function in Adolescents
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rabin Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change from Baseline Lung Clearance Index
Study Overview
Brief Summary
In this prospective study we will evaluate the changes in respiratory physiology occurring in morbidly obese adolescents following bariatric surgery at Schneider Children's Medical Center of Israel (SCMCI).
Detailed Description
Morbid obesity leads to restrictive as well as obstructive ventilatory defects via mechanisms that include mechanical, as well as inflammatory factors. We hypothesise that multiple breath nitrogen washout will be more sensitive to changes in small airway function than conventional lung function testing.
We will invite adolescents with morbid obesity, scheduled to undergo bariatric surgery at SCMCI during 2016-2018, for pulmonary function testing, including spirometry, plethysmography, nitrogen multiple breath washout, lung transfer factor and 6 minute walk. These tests will be conducted prior to the operation as well as during follow-up appointments at 3, 6 and 12 months. We will also evaluate oxidative stress using highly sensitive C-reactive protein as surrogate marker.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 11 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adolescents with morbid obesity who will undergo bariatric surgery at the paediatric surgery ward of Schneider Children's Medical Center during 2016-2018
Exclusion Criteria
- •Adolescents with background diseases which might influence their ability to conduct pulmonary function tests (for example, patients with neurological disorders)
Outcomes
Primary Outcomes
Change from Baseline Lung Clearance Index
Time Frame: 3 months post op
Secondary Outcomes
- Change from Baseline High sensitivity C reactive protein(3 months post op)
Investigators
Patrick Stafler
Dr
Rabin Medical Center