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Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome

Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome - COLOSS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04179188
Acronym
COLOSS
Enrollment
400
Registered
2019-11-27
Start date
2019-10-09
Completion date
2026-05-31
Last updated
2019-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea, Obstructive, Bariatric Surgery Candidate, Obesity

Keywords

obesity, Bariatric Surgery, Obstructive Sleep Apnea

Brief 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. 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.

Interventions

PROCEDUREBariatric surgery

Classical Bariatric surgery (ring, Sleeve gastrectomy or Bypass)

Sponsors

Dr CODRON
CollaboratorUNKNOWN
Ramsay Générale de Santé
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Hypertension1 yearThe primary endpoint is the measurement of Systolic and Diastolic Blood Pressure.

Countries

France

Contacts

Primary ContactJean-François OUDET
jf.oudet@ecten.eu683346567
Backup ContactMarie Barba
mh.barba@ecten.eu+330664888704

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026