Effect of Continuous Positive Airway Pressure on Albuminuria in Patients With Diabetic Nephropathy and Obstructive Sleep Apnea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- Change form baseline in albuminuria levels
研究概览
简要总结
Objectives: Main objective: To assess the effect of 12 months of CPAP treatment added to conventional drug treatment on the albuminuria in patients with diabetic nephropathy and obstructive sleep apnea (OSA). Secondary objectives: To evaluate the effect of CPAP treatment on the estimated glomerular filtration rate of patients with diabetic nephropathy and OSA; determine the additional longterm CPAP effect on glycemic control, insulin resistance, lipid profile, health-related quality of life and biomarkers of cardiac function, inflammation, oxidative stress, sympathetic tone and appetite-regulating hormones in patients with diabetic nephropathy and OSA; and to identify the subgroup of patients with diabetic nephropathy and OSA in which 12 months of treatment with CPAP achieve a more pronounced reduction in albuminuria.
Methodology: Randomized, multicenter, non-blinded, parallel groups, conventional treatment-controlled trial of 12 months of duration.
Subjects will randomize to conventional dietary and pharmacological treatment or conventional dietary and pharmacological treatment plus continuous positive airway pressure (CPAP). Study subjects: Subjects 18 to 80 years with overweight or obesity and a clinical diagnosis of diabetic nephropathy, increased urinary albumin/creatinine ratio of 30 mg/g and an estimated glomerular filtration rate >20 ml/min/1.73 m2, and treatment with stable doses of angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) or anti-aldosterone drugs in the last four weeks. Efficacy variables:
urinary albumin/creatinine ratio and estimated glomerular filtration rate; glycosylated hemoglobin (HbA1c); fasting glucose and insulin; homeostatic model assessment (HOMA) and QUICKI indices; total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides; Troponin I, proBNP, homocysteine and high-sensitivity C-reactive protein; systemic biomarkers (inflammation [IL-6, IL-8 and tumor necrosis factor-α], oxidative stress [8-isoprostane], endothelial damage [endothelin, VCAM-1 and ICAM-1], sympathetic activity [neuropeptide Y] and appetite-regulating hormones [leptin and adiponectin]) and clinical questionnaires: short form (SF)-12, EuroQoL and iPAQ.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 to 80 years old
- •Overweight or obesity (BMI ≥25 kg/m2)
- •Previous diagnosis of type 2 diabetes, fulfilling at least one of the following criteria: 1) current treatment with oral antidiabetic drugs and/or insulin; 2) a fasting glucose value above 126 mg/dl on at least 2 occasions; 3) blood glucose level at 2 hours after an oral glucose tolerance test is equal to or more than 200 mg/dl; or 4) a glycated hemoglobin (HbA1c) level > 6.5 %
- •Clinical diagnosis of diabetic nephropathy, with a urinary albumin/creatinine ratio >30 mg/g and an estimated glomerular filtration rate more than 20 ml/min per 1.73 m
- •Treatment with stable doses of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers or anti-aldosterone agents in the last four weeks.
排除标准
- •Non diabetic nephropathy (confirmed by biopsy).
- •Dialysis for acute renal failure within the 6 previous months.
- •Evidence in the clinic history of relevant bilateral stenosis of renal artery (> 75%)
- •Urinary albumin/creatinine ratio higher than 3000 mg/g, at the baseline visit.
- •Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mm Hg at the baseline visit.
- •Stroke, transient ischemic attack, acute coronary syndrome, or hospitalization for heart failure worsening, within the previous 30 days.
- •Professional drivers, risk profession or respiratory failure.
- •Severe daytime sleepiness (Epworth sleepiness scale >18)
- •Concomitant treatment with high doses of acetylsalicylic acid (> 500 mg/day) or continuous treatment with non-steroidal anti-inflammatory drugs
- •Previous treatment with CPAP
- •Participation in another clinical trial within the 30 days prior to randomization.
研究组 & 干预措施
CPAP treatment
Diet and conventional pharmacological treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists or anti-aldosterone agents plus continuous positive airway pressure (CPAP)
干预措施: Continuous positive airway pressure (Device)
CPAP treatment
Diet and conventional pharmacological treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists or anti-aldosterone agents plus continuous positive airway pressure (CPAP)
干预措施: Pharmacological treatment (Drug)
CPAP treatment
Diet and conventional pharmacological treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists or anti-aldosterone agents plus continuous positive airway pressure (CPAP)
干预措施: Diet (Other)
Control treatment
Diet and conventional pharmacological treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists or anti-aldosterone agents.
干预措施: Pharmacological treatment (Drug)
Control treatment
Diet and conventional pharmacological treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists or anti-aldosterone agents.
干预措施: Diet (Other)
结局指标
主要结局
Change form baseline in albuminuria levels
时间窗: 12 months
To compare the change in albuminuria levels between the patients allocated to CPAP group and the control group
次要结局
- Change form baseline in the plasmatic levels of 8-isoprostane(12 months)
- To identify the CPAP-responder subgroup of OSA patients with diabetic nephropathy(12 months)
- Change from baseline in glycated hemoglobin levels(12 months)
- Change from baseline in the daily physical activity of patients with diabetic nephropathy and OSA(12 months)
- Change form baseline in the plasmatic levels of endothelin(12 months)
- Change from baseline in the health-related quality of life assessed by the SF-12 questionnaire(12 months)
- Change from baseline in the health-related quality of life assessed by the EuroQoL questionnaire(12 months)
- Change form baseline in HOMA index(12 months)
- Change form baseline in QUICKI index(12 months)
- Change from baseline in cholesterol levels(12 months)
- Change from baseline in the levels of C-reactive protein(12 months)
- Change form baseline in the plasmatic levels of biomarkers of inflammation(12 months)
- Change form baseline in the plasmatic levels of appetite-regulating hormones(12 months)
研究者
Francisco Garcia-Rio
MD
Hospital Universitario La Paz