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

NCT ID: NCT04179188

Last Updated: 2019-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-09

Study Completion Date

2026-05-31

Brief Summary

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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

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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

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Obesity Bariatric Surgery Candidate Apnea, Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bariatric OSA Group

Bariatric surgery plannified intervention patient with obstructive sleep Apnéa

Bariatric surgery

Intervention Type PROCEDURE

Classical Bariatric surgery (ring, Sleeve gastrectomy or Bypass)

Bariatric without OSA Group

Bariatric surgery plannified intervention patient without obstructive sleep Apnéa

Bariatric surgery

Intervention Type PROCEDURE

Classical Bariatric surgery (ring, Sleeve gastrectomy or Bypass)

Interventions

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Bariatric surgery

Classical Bariatric surgery (ring, Sleeve gastrectomy or Bypass)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr CODRON

UNKNOWN

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital privé La Louvière

Lille, Haut de France, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-François OUDET

Role: CONTACT

683346567 ext. 683346567

Marie Barba

Role: CONTACT

+330664888704 ext. +330664888704

Facility Contacts

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Marie Barba

Role: primary

+330664888704 ext. +330664888704

Jean Francois OUDET

Role: backup

+33683346567 ext. +33683346567

Other Identifiers

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2019-A00832-55

Identifier Type: -

Identifier Source: org_study_id

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