Epigenetics Modifications in Morbid Obesity and Obstructive Sleep Apnea Patients (EPIMOOSA): Continous Positive Airway Pressure (CPAP) and Bariatric Surgery Impact. EPIMOOSA Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 主要终点
- Epigenetics changes in morbid obesity patient with or without obstructive sleep apnea (OSA)
研究概览
简要总结
This study evaluates epigenetics in morbid obese patients who are waiting for bariatric surgery. A home cardiopulmonary polygraphy is performed to evaluate for the presence of sleep-disordered breathing. The principal investigator make the decision of starting CPAP among patients with obstructive sleep apnea according to current clinical guidelines. One year follow up after bariatric surgery will be performed. A total of 5 visits will be scheduled: two of them before bariatric surgery and 3 after (3, 6 and 12 months).
At every visit, all patients had: sleep questionaries, blood samples, EKG-Holter and spirometry are collected.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI consistently > 40 kg/m2 for 3-5 years, following more than 1 year of unsuccessful controlled medical treatment
- •BMI 35-40 kg/m2 with comorbidities associated with morbid obesity (MO) susceptible to improvement with weight loss (high BP, Diabetes, dyslipidemia, OSA, etc.), following more than 1 year of unsuccessful controlled medical treatment.
- •A signed informed consent form
排除标准
- •Obesity hypoventilation syndrome or treatment with positive pressure devices.
- •Diagnosis of systemic inflammatory disease.
- •Neoplastic diseases in the last 5 years.
- •A cardiovascular event in the last 6 months.
- •Pregnancy
结局指标
主要结局
Epigenetics changes in morbid obesity patient with or without obstructive sleep apnea (OSA)
时间窗: 2 years
To evaluate differences in miRNA profile among patients with morbid obesity with or without OSA Differences between exosome miRNA of MO+OSA and MO-OSA will be calculated. The results will be expressed following the method 2(delta-delta C(T)) miRNA will be analyzed: miRNA 16, 21, 34, 126, 133, 145, 146, 155, 223, 320.
次要结局
- Impact of CPAP treatment in epigenetics changes.(6 months)
- Impact of weight loss due to bariatric surgery in epigenetics changes.(12 months)