NCT03623204

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

2.1 years

First QC Date

August 7, 2018

Last Update Submit

August 8, 2018

Conditions

Obesity

Keywords

ObesityDyspneaBariatric Surgery

Outcome Measures

Primary Outcomes (2)

  • Dyspnea in daily living evaluated using the mMRC scale

    Dyspnea in daily living evaluated using the mMRC scale

    Month 6

  • Dyspnea in daily living evaluated using the mMRC scale

    Dyspnea in daily living evaluated using the mMRC scale

    Month 12

Study Arms (1)

Patients with bariatric surgery for obesity

Other: Dyspnea evaluation

Interventions

Dyspnea evaluationOTHER
Patients with bariatric surgery for obesity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with obesity and who underwent bariatric surgery

You may qualify if:

  • Obesity
  • scheduled bariatric surgery

You may not qualify if:

  • \- age \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

Related Publications (1)

  • Boissiere L, Perotin-Collard JM, Bertin E, Gaubil I, Diaz Cives A, Barbe C, Dury S, Nardi J, Lebargy F, Deslee 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.

    PMID: 28931052BACKGROUND

MeSH Terms

Conditions

ObesityDyspnea

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, Respiratory

Study Design

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

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 9, 2018

Study Start

September 1, 2013

Primary Completion

October 1, 2015

Study Completion

February 1, 2016

Last Updated

August 9, 2018

Record last verified: 2018-08

Locations

FR(1)