Obesity and asthma: effect of bariatric surgery on lung function, inflammation and quality of life.
Completed
- Conditions
- adiposityoverweight1000301810006436
- Registration Number
- NL-OMON33646
- Lead Sponsor
- Sint Franciscus Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Age > 18 and < 50 year.
For the asthma patients: physician diagnosed, persistent asthma
Able to perform a technical correct and reproducable lung function
Acceptable operative risk
BMI > 35 kg/m2.
Approval for 1 year follow-up visits
Exclusion Criteria
Smoking > 10 sig/d or > 10 pack years (PY)
COPD or other pulmonary pathology apart from asthma.
Pregnancy
Exacerbation in 4 weeks prior to screening
Use of oral steroids
Psychological instability
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The group size is powered on the expected change in FEV1/FVC ratio before and<br /><br>after bariatric surgery. Based on our pilot study and the results in the<br /><br>literature we assume that in obese patients with asthma the FEV1/FVC ratio<br /><br>increases from 72% to 75% (SD ± 6). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are symptom score, FeNO levels and inflammatory parameters<br /><br>(see study design).</p><br>