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临床试验/NCT03857191
NCT03857191已完成不适用

Nutritional and Psychocomportemental Reeducation, Sleep Apnea and Comorbidities in Overweight and Obese Subjects

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 396 人开始时间: 2019年3月22日最近更新:
适应症

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

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)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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