ObesityOBES-DYSPNCT03623204
Evolution of Dyspnea After Bariatric Surgery in Patient With Obesity
An observational study of Obesity, run by CHU de Reims at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Dyspnea evaluation
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2013to 1 Feb 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with obesity and who underwent bariatric surgery
Who may be able to join
- Obesity
- scheduled bariatric surgery
Who cannot join
- age < 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Obesity
- Being tested
- Dyspnea evaluation
- Keywords
- Obesity, Dyspnea, Bariatric Surgery
- Medical subject headings
- Obesity, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyspnea evaluationOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with bariatric surgery for obesity | Not described Receives: Other: Dyspnea evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea in daily living evaluated using the mMRC scale
Dyspnea in daily living evaluated using the mMRC scale
Measured: Month 6
Dyspnea in daily living evaluated using the mMRC scale
Dyspnea in daily living evaluated using the mMRC scale
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Sep 2013
- Primary completion1 Oct 2015
- Study completion1 Feb 2016
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.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623204
- Sponsor's protocol ID
- 2017Ao007
- Acronym
- OBES-DYSP
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28931052
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Dyspnea After Bariatric Surgery in Patient With Obesity
- ClinicalTrials.gov ID
- NCT03623204
- Acronym / sponsor ID
- OBES-DYSP / 2017Ao007
- Conditions
- Obesity
- Keywords
- Obesity, Dyspnea, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Oct 2015 (actual)
- Study completion
- 1 Feb 2016 (actual)
- First posted
- 9 Aug 2018 (actual)
- 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.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bariatric surgery for obesity | – | Other: Dyspnea evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with obesity and who underwent bariatric surgery
Key inclusion criteria (2 listed)
- Obesity
- scheduled bariatric surgery
Key exclusion criteria (1 listed)
- age < 18 years old
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 |
|---|---|---|
| Dyspnea evaluation | Other | Patients with bariatric surgery for obesity |
Primary outcome
Dyspnea in daily living evaluated using the mMRC scale
Time frame: Month 6
Dyspnea in daily living evaluated using the mMRC scale
Dyspnea in daily living evaluated using the mMRC scale
Time frame: Month 12
Dyspnea in daily living evaluated using the mMRC scale
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 9 Aug 2018.
- Background: PubMed 28931052Boissiere 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 CHU de Reims 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 2 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 9 Aug 2018. 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?
Dyspnea in daily living evaluated using the mMRC scale (time frame: Month 6). The study lists 2 primary outcomes in all. 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 NCT03623204, 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 9 Aug 2018.