ObesityCOLOSSNCT04179188
Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome
An observational study of Obesity and Bariatric Surgery Candidate, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
It has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors. Among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (OSA) syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate, Apnea, Obstructive
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2019to 31 May 2026
- 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: Patient in preparation for bariatric surgery in the center CELIOBE
Who may be able to join
- Patient, male or female, aged over 18
- Patient in preparation for bariatric surgery (ring, Sleeve gastrectomy or Bypass) in the center CELIOBE.
- Patient affiliated with social security or beneficiary of such a scheme
- Patient having signed the free and informed consent
Who cannot join
- Patient who has already had bariatric surgery (ring, sleeve gastrectomy or bypass).
- Patient already receiving CPAP treatment for sleep apnea syndrome.
- Patients with pathology indicating the use of CPAP in self-guided mode (heart failure with altered ejection fraction) for patients diagnosed with OSAS
- Patient likely, in the opinion of the investigator, not to be cooperative or respectful of the obligations inherent to participation in the study
- Patient suffering from mental pathology does not make possible the collection of a consent.
- Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant, lactating or parturient woman
- Patient hospitalized without consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital privé La Louvière
Lille, Haut de France, 59800
Marie Barba, +330664888704 ext. +330664888704, mh.barba@ecten.eu
Jean Francois OUDET, +33683346567 ext. +33683346567, jf.oudet@ecten.eu
About this study
Official title: Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome - COLOSS
It has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors. Among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (OSA) syndrome. Given the strong associations between OSA and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in OSAS patients.
Read the detailed description
It has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors.
Bariatric surgery is now the most effective intervention for the long-term treatment of obesity and its complications. Among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (OSA) syndrome. The progressive loss of weight contributes to the regression of the symptoms related to OSA. Observational studies have shown that bariatric surgery can rapidly improve glycemic control and cardiovascular risk factors with a significantly higher remission rate of hypertension and dyslipidemias than in the non-surgical group. Given the strong associations between OSA and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in OSAS patients.
- Conditions
- Obesity, Bariatric Surgery Candidate, Apnea, Obstructive
- Being tested
- Bariatric surgery
- Keywords
- obesity, Bariatric Surgery, Obstructive Sleep Apnea
- Medical subject headings
- Obesity, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Classical Bariatric surgery (ring, Sleeve gastrectomy or Bypass)
| Study group | Role | What they receive |
|---|---|---|
| Bariatric OSA Group | Bariatric surgery plannified intervention patient with obstructive sleep Apnéa Receives: Procedure: Bariatric surgery | |
| Bariatric without OSA Group | Bariatric surgery plannified intervention patient without obstructive sleep Apnéa Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension
The primary endpoint is the measurement of Systolic and Diastolic Blood Pressure.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start9 Oct 2019
- Primary completion30 Nov 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dr CODRON
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179188
- Sponsor's protocol ID
- 2019-A00832-55
- Acronym
- COLOSS
- Status last verified
- Nov 2019
- First submitted
- 25 Nov 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome - COLOSS
- ClinicalTrials.gov ID
- NCT04179188
- Acronym / sponsor ID
- COLOSS / 2019-A00832-55
- Conditions
- Obesity, Bariatric Surgery Candidate, Apnea, Obstructive
- Keywords
- obesity, Bariatric Surgery, Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Dr CODRON
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 27 Nov 2019 (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.
It has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors. Among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (OSA) syndrome. Given the strong associations between OSA and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in OSAS patients.
Detailed description
It has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors.
Bariatric surgery is now the most effective intervention for the long-term treatment of obesity and its complications. Among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (OSA) syndrome. The progressive loss of weight contributes to the regression of the symptoms related to OSA. Observational studies have shown that bariatric surgery can rapidly improve glycemic control and cardiovascular risk factors with a significantly higher remission rate of hypertension and dyslipidemias than in the non-surgical group. Given the strong associations between OSA and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in OSAS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric OSA Group | – | Procedure: Bariatric surgeryBariatric surgery plannified intervention patient with obstructive sleep Apnéa |
| Bariatric without OSA Group | – | Procedure: Bariatric surgeryBariatric surgery plannified intervention patient without obstructive sleep Apnéa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient in preparation for bariatric surgery in the center CELIOBE
Key inclusion criteria (4 listed)
- Patient, male or female, aged over 18
- Patient in preparation for bariatric surgery (ring, Sleeve gastrectomy or Bypass) in the center CELIOBE.
- Patient affiliated with social security or beneficiary of such a scheme
- Patient having signed the free and informed consent
Key exclusion criteria (8 listed)
- Patient who has already had bariatric surgery (ring, sleeve gastrectomy or bypass).
- Patient already receiving CPAP treatment for sleep apnea syndrome.
- Patients with pathology indicating the use of CPAP in self-guided mode (heart failure with altered ejection fraction) for patients diagnosed with OSAS
- Patient likely, in the opinion of the investigator, not to be cooperative or respectful of the obligations inherent to participation in the study
- Patient suffering from mental pathology does not make possible the collection of a consent.
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 |
|---|---|---|
| Bariatric surgeryClassical Bariatric surgery (ring, Sleeve gastrectomy or Bypass) | Procedure or surgery | Bariatric OSA Group, Bariatric without OSA Group |
Primary outcome
Hypertension
Time frame: 1 year
The primary endpoint is the measurement of Systolic and Diastolic Blood Pressure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 and Bariatric Surgery Candidate, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 27 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François OUDET (683346567 ext. 683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertension (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2019.