Nutritional and Psychocomportemental Reeducation, Sleep Apnea and Comorbidities in Overweight and Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- Difference in OSA risk before and after nutritional and psychocomportemental rehabilitation
研究概览
简要总结
In obese patients, the prevalence of obstructive sleep apnea (OSA) is around 40% in men and 30% in women. Weight loss after bariatric surgery significantly improves OSA, with 75% of patients having a reduction in OSA severity or becoming non-apneic. We hypothesize a similar effect on OSA of nutritional and psychocomportemental rehabilitation for obese patients. However, we expect weight loss and blood pressure reduction to probably be lower in obese patients who have OSA and nutritional rehabilitation alone than in those who are treated for their OSA or are without OSA. To address this question, we will conduct an observational study on obese patients, treated or not for OSA, following nutritional and psychocomportemental rehabilitation.
详细描述
In obese patients, OSA prevalence is around 40% in men and 30% in women. Being overweight or obese are independent risk factors for OSA, and the prevalence increases with body mass index (BMI). Weight loss after bariatric surgery is one treatment for OSA, 75% of patients having a reduction in OSA severity or becoming non-apneic. OSA and obesity both induce type 2 diabetes, hypertension and/or nonalcoholic fatty liver disease (NAFLD). A randomized study (Chirinos et al. NEJM 2014) demonstrated a better improvement in blood pressure, triglyceride levels or insulin resistance with weight loss alone or weight loss associated with continuous positive airway pressure (CPAP) than with CPAP alone. We hypothesize a similar effect of nutritional and psychocomportemental rehabilitation on OSA. However, weight loss and blood pressure improvements could be lesser in untreated OSA patients than in treated OSA or non-OSA patients. It has been demonstrated that bariatric surgery reduces medication use such as antihypertensive or antidiabetic drugs, and thus a secondary objective is to determine whether nutritional and psychocomportemental rehabilitation similarly reduces medication use by the overweight and obese.
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
- •BMI > 25 kg/m² and/or waist circumference > 80 cm in women or 94 cm in men
- •Patients registered to follow a nutritional psychocomportemental reeducation program with the "Ethique et Santé" group
排除标准
- •- Subjects covered by articles L1121-5 to L1121-8 of French law
结局指标
主要结局
Difference in OSA risk before and after nutritional and psychocomportemental rehabilitation
时间窗: 25 weeks
Berlin questionnaire score of patients will be compared before and after weight loss (if any) by nutritional psychocomportemental reeducation
次要结局
- Weight loss according to OSA status(25 weeks)
- Difference in daytime sleepiness before and after nutritional and psychocomportemental rehabilitation(25 weeks)
- Change in Medication use according to OSA status(25 weeks)
- Change in Blood pressure according to OSA status(25 weeks)
- To assess the effect of Weight loss on OSA(25 weeks)
