NCT02207192

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

3.2 years

First QC Date

August 1, 2014

Last Update Submit

August 5, 2014

Conditions

Keywords

obesity, lung volumes, postural changes

Outcome Measures

Primary Outcomes (1)

  • functional residual capacity

    baseline and one year after bariatric surgery

Secondary Outcomes (1)

  • lung volumes and flows

    at baseline and after bariatric surgery

Study Arms (1)

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.

Other: Postural change in lung volumes: sitting to Supine

Interventions

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.

Morbidly obese

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • subjects scheduled for bariatric surgery (BMI over or equal to 40 kg/m2)

You may not qualify if:

  • Subjects with respiratory and cardiac history (asthma, COPD, heart failure) were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University hospital

Montpellier, 34295, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mustapha Sebbane, MD, PhD

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2014

First Posted

August 4, 2014

Study Start

August 1, 2005

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

August 6, 2014

Record last verified: 2014-08

Locations