Effectiveness of an Intensive Weight Loss Program for Obstructive Sleep Apnea Syndrome (OSAS) Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Improvement in the apnea-hypopnea index/hour: Sleep study: Standard polysomnography
研究概览
简要总结
The purpose of this study is to determine if a lifestyle change program for obese patients who are already receiving continuous positive airway pressure (CPAP) treatment can achieve weight loss and overall improvement of obstructive sleep apnea syndrome (OSAS).
详细描述
Calculating the sample size:
The primary endpoint is the reduction of final apnea-hypopnea index (AHI) with respect to baseline. Assuming an alpha level of 0.05 and a bilateral approach to have 80% statistical power, the investigators estimate a final sample size of 42 patients is required to detect a 15 point difference in AHI between the intervention and control groups (clinically relevant difference), with a standard deviation of 15 (visit 9) and accounting for a 25% rate of attrition. Balanced groups are expected.
Lifestyle Change Program:
This will consist of a 3-month long first stage of intensive diet and progressive exercise with visits to a nutritionist every 15 days. A second stage will last until completion of one year, with a diet that is progressively higher in calories, more intense exercise, appointments that are spaced further apart and are alternatively individual and group visits.
Diet First stage: 12 weeks
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
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been diagnosed with severe obstructive sleep apnea syndrome (AHI > 30) and are already receiving CPAP treatment (since at least 6 months), who have class I and class II obesity (body mass index (BMI) >= 30 kg /m2 y <= 40 kg/m2).
排除标准
- •diseases that limit exercising or diet,
- •cognitive impairment that prevents understanding the program,
- •psychiatric disorders,
- •severe diseases, major cardiovascular disease,
- •clinical instability within the previous month,
- •prior bariatric surgery,
- •refusal to participate in the study,
- •participation in another clinical trial.
研究组 & 干预措施
Regular program
Intensive weight loss program
干预措施: Intensive weight loss program (Behavioral)
结局指标
主要结局
Improvement in the apnea-hypopnea index/hour: Sleep study: Standard polysomnography
时间窗: Baseline, at 3 months and 12 months.
Assess whether a lifestyle change program can be effective in the medium and long term for the treatment of OSAS in obese patients with OSAS who are already receiving CPAP treatment.
次要结局
- Thyroid-Stimulating Hormone (TSH)(Baseline, at 3 months and 12 months)
- Glycosylated hemoglobin(Baseline, at 3 months and 12 months)
- Body fat composition by bioimpedance analysis (BIA 101, Akern Bioresearch, Florence, Italy).(Baseline, at 3 months and 12 months.)
- waist circumference (above the upper iliac crest): centimetre(Baseline, at 3 months and 12 months.)
- neck circumfarence: centimetre(Baseline, at 3 months and 12 months.)
- waist to hip ratio(Baseline, at 3 months and 12 months.)
- Exercise capacity: 6 minute walk test (6MWT)(Baseline, at 3 months and 12 months.)
- Blood pressure(Baseline, at 3 months and 12 months.)
- Markers of hemodynamic dysfunction: N-terminal pro brain natriuretic peptide (NT-proBNP)(Baseline, at 3 months and 12 months.)
- Markers of inflammation: interleukin (IL) 6, IL-8, tumor necrosis factor (TNF) alpha and TNF soluble receptors 1 and 2, adiponectin(Baseline, at 3 months and 12 months.)
- Weight (kilograme)(Baseline, at 3 months, and 12 months.)
- Body mass index (BMI): dividing weight in kilograms by height in meters squared(Baseline, at 3 months, and 12 months.)
- Prothrombin time (PT)(Baseline, at 3 months and 12 months)
- Activated partial thrombopastin time (APTT)(Baseline, at 3 months and 12 months)
- Measurement of visceral fat (square centimetre) by an abdominal computerized tomography (CT) scan(Baseline, at 12 months.)
- Record of physical activity: hours of exercise will be noted daily in a journal(Baseline, at 3 months and 12 months.)
- Pain: VAS Analog Scale for Pain(Baseline, at 3 months and 12 months.)
- Glucose (millimole/liter)(Baseline, at 3 months and 12 months.)
- Adherence to diet monitoring by diet questionnaries(Baseline, at 3 months and 12 months)
- Low density lipoprotein (LDL) cholesterol (millimole/liter)(Baseline, at 3 months and 12 months)
- High density lipoprotein (LDL) cholesterol (millimole/liter)(Baseline, at 3 months and 12 months)
- Creatinine (micromole/liter)(Baseline, at 3 months and 12 months)
- Carotid intima-media (C-IMT) thickness (millimeter (mm)) by ultrasound of the supra-aortic vessels, using B-mode ultrasound(Baseline, at 3 months and 12 months.)
- Age (years)(Baseline, at 3 months and 12 months.)
- Cardiovascular risk factors and comorbidity.(Baseline, at 3 months and 12 months.)
- OSAS-related symptoms(Baseline, at 3 months and 12 months.)
- CPAP related side effects(Baseline, at 3 months and 12 months.)
- Hours of sleep(Baseline, at 3 months and 12 months.)
- Markers of oxidative stress: isoprostanes(Baseline, at 3 months and 12 months.)
- Alanine aminotransferase (microgram/liter)(Baseline, at 3 months and 12 months)
- Triglycerides (millimole/liter)(Baseline, at 3 months and 12 months)
- Platelet activation and markers of the fibrinolytic system: p-selectin, Soluble CD40 ligand (sCD40), Plasminogen activator inhibitor (PAI-1)(Baseline, at 3 months and 12 months.)
- Height (meter)(Baseline, at 3 months, and 12 months.)
- Aspartate aminotransferase (microgram/liter)(Baseline, at 3 months and 12 months)
- Self-perceived sleepiness(Baseline, at 3 months and 12 months.)
- Testing for ketones (milligram/deciliter) using test strips(Baseline, at 3 months and 12 months.)
- CPAP compliance (mean hours of usage per night as recorded by the hour meters).(Baseline, at 3 months and 12 months.)
- Fibrinogen (gram/liter)(Baseline, at 3 months and 12 months.)
- Markers of endothelial dysfunction: Asymetric Dimethylarginine (ADMA), intercellular adhesion molecule (ICAM-1), vascular endothelial cell adhesion molecule (VCAM-1), vascular endothelial growth factor (VEGF), endothelin(Baseline, at 3 months and 12 months.)
- Gender: male, female(Baseline)
- Start of Obesity: period of obesity(Baseline)
- D-dimer (microgram/liter)(Baseline, at 3 months and 12 months)
- Total cholesterol (millimole/liter)(Baseline, at 3 months and 12 months)
- Uric acid (micromole/liter)(Baseline, at 3 months and 12 months)
- C-reactive protein (milligram/liter)(Baseline, at 3 months and 12 months)
- Measurement of health-related quality of life(Baseline, at 3 months and 12 months.)
研究者
Carmen Monasterio
Doctor
Hospital Universitari de Bellvitge