Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome - COLOSS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Hypertension
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Hypertension
时间窗: 1 year
The primary endpoint is the measurement of Systolic and Diastolic Blood Pressure.
次要结局
未报告次要终点