ObesityNCT02207192
Postural Changes in Lung Volumes in Obesity
An observational study of Obesity, run by Association pour la Formation du Personnel à la Medecine d'Urgence at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Postural change in lung volumes: sitting to Supine
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2005to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- subjects scheduled for bariatric surgery (BMI over or equal to 40 kg/m2)
Who cannot join
- Subjects with respiratory and cardiac history (asthma, COPD, heart failure) were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- Postural change in lung volumes: sitting to Supine
- Keywords
- obesity, lung volumes, postural changes
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural change in lung volumes: sitting to SupineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Postural change in lung volumes: sitting to Supine |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional residual capacity
Measured: baseline and one year after bariatric surgery
Secondary outcomes (1)
lung volumes and flows
Measured: at baseline and after bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startAug 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour la Formation du Personnel à la Medecine d'Urgence
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mustapha Sebbane, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207192
- Sponsor's protocol ID
- FRC obesity
- Status last verified
- Aug 2014
- First submitted
- 1 Aug 2014
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sebbane M, El Kamel M, Millot A, Jung B, Lefebvre S, Rubenovitch J, Mercier G, Eledjam JJ, Jaber S, Hayot M. Effect of Weight Loss on Postural Changes in Pulmonary Function in Obese Subjects: A Longitudinal Study. Respir Care. 2015 Jul;60(7):992-9. doi: 10.4187/respcare.03668. Epub 2015 Apr 7.
PubMed 25852166
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight Loss on Postural Changes in Pulmonary Function : a Longitudinal Study in Morbidly Obese to Obese Subjects Following Gastroplasty
- ClinicalTrials.gov ID
- NCT02207192
- Acronym / sponsor ID
- FRC obesity
- Conditions
- Obesity
- Keywords
- obesity, lung volumes, postural changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Association pour la Formation du Personnel à la Medecine d'UrgenceUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morbidly obese | – | Other: Postural change in lung volumes: sitting to SupineConsecutive 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. |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- subjects scheduled for bariatric surgery (BMI over or equal to 40 kg/m2)
Key exclusion criteria (1 listed)
- Subjects with respiratory and cardiac history (asthma, COPD, heart failure) were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postural change in lung volumes: sitting to SupinePulmonary 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. | Other | Morbidly obese |
Primary outcome
functional residual capacity
Time frame: baseline and one year after bariatric surgery
1 secondary outcome
lung volumes and flows
Time frame: at baseline and after bariatric surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
- Derived from this study: PubMed 25852166Sebbane M, El Kamel M, Millot A, Jung B, Lefebvre S, Rubenovitch J, Mercier G, Eledjam JJ, Jaber S, Hayot M. Effect of Weight Loss on Postural Changes in Pulmonary Function in Obese Subjects: A Longitudinal Study. Respir Care. 2015 Jul;60(7):992-9. doi: 10.4187/respcare.03668. Epub 2015 Apr 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustapha Sebbane, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Association pour la Formation du Personnel à la Medecine d'Urgence at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional residual capacity (time frame: baseline and one year after bariatric surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02207192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.