Impact of Obstructive Sleep Apnea Syndrome on Metabolic Syndrome in Severe Obesity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- To analyze the effect of CPAP treatment on insulin resistance and metabolic syndrome in patients with severe obesity and OSA.
研究概览
简要总结
The aim of this project is to study the relationship between obstructive sleep apnea (OSA) and metabolic syndrome (MS) in a population of obese patients who are candidates for bariatric surgery. The investigators will study the influence of OSA through hypoxia and sleep fragmentation on different proinflammatory adipokines and cytokines, on metabolic syndrome and on insulin resistance, as well as how these respond to treatment with continuous positive airway pressure (CPAP).
In the first part of the study (part A) the investigators will perform an observational study of cases and controls. Based on the diagnostic polysomnography the patients will be divided into two groups depending on their apnea-hypopnea index (AHI): OSA (AHI >= 15/h) and non-OSA (AHI <15/h). The results will be analyzed depending on the presence or not of OSA.
In the second part of the study (part B), the patients with severe OSA (AHI ≥ 30/h) will be randomized into two groups: one group will receive CPAP + diet treatment and the other group will only receive diet treatment. After 3 months of treatment (CPAP + diet vs. diet), the investigators will analyze the overall effect on metabolic syndrome and the effect on its individual components, as well as the above-mentioned inflammatory pathways and insulin sensitivity, between the 2 groups. This will be carried out through a randomized controlled study in which the investigators will compare the effect of CPAP with the effect of conservative treatment.
详细描述
METHODOLOGY
PARTICIPATING CENTERS: Respiratory Medicine and Endocrinology Services of the Hospital Universitari de Bellvitge, of the Hospital de la Santa Creu i Sant Pau and of Hospital Clínic de Barcelona.
PATIENTS (recorded in eligibility criteria)
Ethical aspects: All patients will be asked for informed consent in accordance with the procedures of the Ethical Committee of the hospitals. Patients will be recruited in the initial stage of the protocol and waiting list for bariatric surgery. Currently the waiting list is 2 to 3 years long and the patients are screened for OSA in the year before the intervention, with the aim of treating OSA patients in order to reduce the perioperative surgical risk. Therefore the protocol will not lead to a delay in the start of treatment, since treatment will be commenced earlier than usual. Once the study period is over, the patients in the control group will receive CPAP if necessary.
DESIGN:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for part A:
- •Patients who are included in the obesity surgery program will be recruited if they fulfill the following criteria:
- •Age between 18 and 65 years.
- •Body mass index (BMI) >40 kg/m2 or BMI > 35 kg/m2 with co-morbidity related to obesity.
- •Inclusion Criteria for part B:
- •In the treatment response study we will include patients diagnosed at the baseline polysomnography with severe OSA (AHI >= 30) who fulfill the inclusion criteria for part A and who do not present specific
排除标准
- •for part B.
- •General Exclusion Criteria (for part A):
- •Prior treatment with CPAP.
- •Severe or unstable cardiovascular disease (severe or surgically treated valvulopathy, myocardial infarction, unstable angina, cardiac surgery) during the 6 months prior to inclusion in the study.
- •Evidence of acute or chronic inflammatory illness different to obesity itself (connective tissue disease, active neoplasia) or associated infectious process during the 6 weeks prior to inclusion in the study.
- •Severe cognitive or psychiatric disorder that would make it difficult to complete the clinical questionnaires.
- •Severe chronic diseases that may interfere in a significant way with the results of the study.
- •Chronic obstructive pulmonary disease defined by FEV1/FVC < 0.
- •Pregnancy.
- •Alcohol abuse (daily alcohol consumption >80 g).
- •Express decision of the patient to not participate in the study.
- •Exclusion Criteria for part B:
- •Severe or incapacitating somnolence.
- •Professional drivers or users of dangerous machinery.
- •Congestive cardiac insufficiency or significant valvulopathy or chronic cor pulmonale.
- •Use of oral anti-diabetic drugs or insulin.
结局指标
主要结局
To analyze the effect of CPAP treatment on insulin resistance and metabolic syndrome in patients with severe obesity and OSA.
时间窗: baseline and after 12 weeks of CPAP
次要结局
- To study the relationship between OSA and metabolic syndrome in a population of severely obese patients who are candidates for bariatric surgery.(baseline and after 12 weeks of CPAP)
- To study the influence of OSA on proinflammatory markers and on different adipokines in severely obese patients and their relationship with metabolic syndrome, insulin resistance and body composition.(baseline and after 12 weeks of CPAP)