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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03623204
Other study ID # 2017Ao007
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2013
Est. completion date February 1, 2016

Study information

Verified date August 2018
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Obesity, defined as a Body Mass Index greater than or equal to 30 kg/m2, represents a significant public health issue. Dyspnea is a very common and crippling symptom in obesity. About 80% of people with obesity experience dyspnea in daily living. Bariatric surgery has been demonstrated to be an excellent treatment for obesity by inducing significant weight loss. Nevertheless, changes in dyspnea in daily living after bariatric surgery and the links between variations in dyspnea and lung function tests after bariatric surgery have not been previously investigated.


Description:

The objective of this study was to determine if bariatric surgery is associated with an improvement of dyspnea in daily living according to the mMRC scale in patients with obesity.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date February 1, 2016
Est. primary completion date October 1, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Obesity

- scheduled bariatric surgery

Exclusion Criteria:

- age < 18 years old

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dyspnea evaluation


Locations

Country Name City State
France Damien JOLLY Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

References & Publications (1)

Boissière L, Perotin-Collard JM, Bertin E, Gaubil I, Diaz Cives A, Barbe C, Dury S, Nardi J, Lebargy F, Deslée G, Launois C. Improvement of dyspnea after bariatric surgery is associated with increased Expiratory Reserve Volume: A prospective follow-up study of 45 patients. PLoS One. 2017 Sep 20;12(9):e0185058. doi: 10.1371/journal.pone.0185058. eCollection 2017. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Dyspnea in daily living evaluated using the mMRC scale Dyspnea in daily living evaluated using the mMRC scale Month 6
Primary Dyspnea in daily living evaluated using the mMRC scale Dyspnea in daily living evaluated using the mMRC scale Month 12
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