Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- OBJECTIVES: To compare the plasmatic profiles of different hormones
研究概览
简要总结
The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have different pattern in the secretion of hormones.
The chronic sleep disorganization that suffer patients with sleep apnea-hypopnea syndrome (SAHS) may affect the central mechanisms that regulate nutritive behavior and energetic balance, causing an alteration in the secretion of hormones that favour the appearance and/or development of obesity.
详细描述
OBJECTIVES: To compare the plasmatic profiles of different hormones and neuropeptides, related with weight control, metabolism and intake in patients with SAHS as well as in selected control subjects according to weight.
DESIGN: Multicenter, prospective and controlled study. 40 patients with SAHS will be included as well as 40 control subjects.
METHODS: To all subjects included in the study, the following procedures will be performed:
- Medical History;
- Anthropometric variables (height, weight, Body Mass Index;
- Somnolence evaluation using the Epworth scale;
- Conventional Polysomnography (PSG);
- Determination every four hours during a 24 hours period of the levels of leptin adiponectin, resistin, insulin, PCR, etc.
- Conventional biologic evaluation;
- Patients will be re-evaluated after three months of treatment with CPAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Apnea-Hypopnea Index > 15
- •Body Mass Index < 27 or > 30 Kg/m2
排除标准
- •Presence of any chronic disease
- •Drug addiction and/or alcoholism
- •Refusal to sign informed consent
结局指标
主要结局
OBJECTIVES: To compare the plasmatic profiles of different hormones
and neuropeptides, related with weight control, metabolism and intake
in patients with SAHS as well as in selected control subjects according
to weight.
次要结局
- CPAP (Continuous Positive Airway Pressure) effect on studied variables