Treating Sleep Apnea in Type 2 Diabetes Mellitus: A Randomized Clinical Trial

描述(申请人提供)：2型糖尿病是一种慢性疾病，对公众健康造成很大负担。据估计，近2580万人 美国人患有糖尿病。尽管在糖尿病的管理方面取得了巨大的进步，但相当一部分患者会出现视网膜病变、神经病变和肾病等微血管并发症，以及亚临床动脉粥样硬化、冠状动脉疾病和脑血管疾病等大血管并发症。虽然血糖控制是糖尿病管理的中心焦点，但针对其他可能恶化血糖控制和/或增加大血管疾病风险的因素是同时的治疗目标。管理糖尿病的临床医生面临的一个关键问题是需要额外的策略，这些策略可以添加到医疗设备中，以改善血糖控制。过去十年的研究表明，阻塞性睡眠呼吸暂停(OSA)是糖尿病患者的常见疾病。来自多项不同研究的数据显示，糖尿病患者中至重度OSA的患病率超过50%。此外，观察和实验证据表明，OSA的间歇性低氧血症和反复觉醒可能会改变葡萄糖代谢，恶化血糖控制。然而，持续气道正压(CPAP)治疗阻塞性睡眠呼吸暂停综合征(OSA)对血糖控制的影响尚未明确。关于CPAP治疗糖尿病患者阻塞性睡眠呼吸暂停是否能改善血糖控制、降低血压和逆转内皮功能障碍，目前还没有进行足够有力的随机临床试验。我们的初步数据表明，CPAP治疗OSA 6个月对血糖控制、餐后高血糖、昼夜血压和内皮功能有良好的效果。根据这些发现，这项建议的首要目标是确定CPAP治疗糖尿病患者阻塞性睡眠呼吸暂停综合征是否在以下方面有所改善：(A)糖化血红蛋白(HbA1c)；(B)通过自我监测血糖和持续监测血糖来评估血糖变异性；(C)血压；(D)交感神经迷走神经平衡；(E)内皮功能；(F)氧化应激；(G)血脂异常。我们建议在糖尿病和中到重度阻塞性睡眠呼吸暂停患者中进行一项随机对照试验，他们将被随机分配到CPAP治疗6个月，同时接受生活方式咨询或仅接受生活方式咨询。在这项临床试验的背景下，我们将调查上述临床结果的全部内容。

DESCRIPTION (provided by applicant): Type 2 diabetes mellitus is a chronic medical condition that imposes a substantial public health burden. It is estimated that nearly 25.8 million people in the United States have diabetes. Despite enormous advances in the management of diabetes, a significant number of those affected develop microvascular complications such as retinopathy, neuropathy, and nephropathy, as well as macrovascular complications including subclinical atherosclerosis, coronary artery disease, and cerebrovascular disease. While glycemic control is a central focus of diabetes management, targeting other factors that can either worsen glycemic control and/or increase the risk of macrovascular disease are concurrent therapeutic goals. A critical issue facing clinicians that manage diabetes is the need for additional strategies that can be added to the armamentarium for improving glycemic control. Research over the last decade has shown that obstructive sleep apnea (OSA) is a common condition in people with diabetes. Data from a number of different studies show that the prevalence of moderate to severe OSA in diabetics is more than 50%. Furthermore, observational and experimental evidence indicates that intermittent hypoxemia and recurrent arousals in OSA may alter glucose metabolism and worsen glycemic control. However, the impact of treating OSA with continuous positive airway pressure (CPAP) therapy on glycemic control is not well defined. Adequately powered randomized clinical trials have yet to be performed to demonstrate whether CPAP therapy for OSA in diabetics can improve glycemic control, decrease blood pressure, and reverse endothelial dysfunction. Our preliminary data suggest that treatment of OSA with CPAP for 6 months has favorable effects on glycemic control, postprandial hyperglycemia, diurnal blood pressure, and endothelial function. Based on these findings, the overarching goal of this proposal is to determine whether CPAP therapy for OSA in diabetics leads to improvements in (a) glycosylated hemoglobin (HbA1c); (b) glycemic variability as assessed by self-monitoring of blood glucose and continuous monitoring of glucose; (c) blood pressure; (d) sympathovagal balance; (e) endothelial function; (f) oxidative stress; and (g) dyslipidemia. We propose to conduct a randomized control trial in subjects with diabetes and moderate to severe OSA who will be randomly assigned for 6 months to CPAP with lifestyle counseling or lifestyle counseling alone. In the context of this clinical trial, we ill investigate the repertoire of aforementioned clinical outcomes.