- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02207192
Postural Changes in Lung Volumes in Obesity
August 5, 2014 updated by: Association pour la Formation du Personnel à la Medecine d'Urgence
Effect of Weight Loss on Postural Changes in Pulmonary Function : a Longitudinal Study in Morbidly Obese to Obese Subjects Following Gastroplasty
Postural changes are known to affect normal lung volumes.
A reduction in sitting to supine functional residual capacity (FRC) is well-described in non-obese subjects adopting a supine position.
However, postural changes in lung volumes in the obese require further exploration.
We aimed to longitudinally address the effects of weight loss on postural changes in lung volumes and pulmonary function, in obesity.
We tested the hypothesis that supine reduction in FRC would be absent in morbid obesity and recovered upon weight loss.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Montpellier, France, 34295
- Montpellier University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 60 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Twelve morbidly obese adults (BMI over or equal to 40 kg/m2) scheduled for bariatric surgery at the Montpellier university hospital were recruited.
They were 3 men and 9 women.
Description
Inclusion Criteria:
- subjects scheduled for bariatric surgery (BMI over or equal to 40 kg/m2)
Exclusion Criteria:
- Subjects with respiratory and cardiac history (asthma, COPD, heart failure) were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Morbidly obese
Consecutive morbidly obese adults (BMI over or equal to 40 kg/m2) scheduled for bariatric surgery were prospectively recruited.Subjects with respiratory and cardiac history (asthma, Chronic obstructive pulmonary disease, heart failure) were excluded.
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Pulmonary function and arterial blood gases were assessed both prior to and after weight loss as part of pre-operative and 12-month follow-up evaluations. Pulmonary function tests were performed both in the sitting and then in the supine position. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
functional residual capacity
Time Frame: baseline and one year after bariatric surgery
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baseline and one year after bariatric surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
lung volumes and flows
Time Frame: at baseline and after bariatric surgery
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at baseline and after bariatric surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mustapha Sebbane, MD, PhD, Montpellier University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
August 1, 2014
First Submitted That Met QC Criteria
August 1, 2014
First Posted (Estimate)
August 4, 2014
Study Record Updates
Last Update Posted (Estimate)
August 6, 2014
Last Update Submitted That Met QC Criteria
August 5, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FRC obesity
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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