1 Baker IDI Heart and Diabetes Institute, Melbourne, Victoria, Australia.
2 Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Am J Respir Crit Care Med. 2016 Aug 15;194(4):486-92. doi: 10.1164/rccm.201511-2260OC.
There is uncertainty about the effects of treating obstructive sleep apnea on glycemic control in patients with type 2 diabetes.
To determine whether treatment of obstructive sleep apnea in patients with type 2 diabetes improves glycemic control.
In this trial, we randomized patients with type 2 diabetes and no previous diagnosis of obstructive sleep apnea, with a glycated hemoglobin level of 6.5-8.5%, and an oxygen desaturation index of 15 or more events per hour to positive airway pressure therapy or to usual care.
A total of 416 patients met the entry criteria as determined by each site and were randomized. Of the 298 participants who met centrally adjudicated entry criteria, no differences between the study groups were seen for change in glycated hemoglobin. Furthermore, there were no between-group differences when analyses were restricted to those with poorer baseline glycemic control, those with more severe sleep apnea, or those who were adherent to therapy. A greater fall in diastolic blood pressure occurred in the positive airway pressure group than in the usual care group (-3.5 mm Hg vs. -1.5 mm Hg; P = 0.07). This difference was significant in those who were adherent to positive airway pressure therapy (-4.4 mm Hg vs. -1.6 mm Hg; P = 0.02). There was a significant reduction in sleepiness in the positive airway pressure therapy group (P < 0.0001). Quality of life assessment revealed improvements in vitality, mental health, and mental component summary scores in the positive airway pressure therapy group.
This trial showed no effect of positive airway pressure therapy on glycemic control in patients with relatively well-controlled type 2 diabetes and obstructive sleep apnea. Clinical trial registered with www.clinicaltrials.gov (NCT00509223).
对于 2 型糖尿病患者，治疗阻塞性睡眠呼吸暂停对血糖控制的影响尚不确定。
确定治疗 2 型糖尿病患者的阻塞性睡眠呼吸暂停是否改善血糖控制。
在这项试验中，我们将 2 型糖尿病且此前未诊断为阻塞性睡眠呼吸暂停、糖化血红蛋白水平为 6.5-8.5%、每小时氧减指数为 15 次或以上的患者随机分为气道正压治疗组或常规治疗组。
共有 416 名符合各中心标准的患者符合入组条件并被随机分组。在 298 名符合中心评估标准的入组患者中，研究组间糖化血红蛋白的变化无差异。此外，当分析仅限于基线血糖控制较差、睡眠呼吸暂停较重或治疗依从性较好的患者时，组间也无差异。与常规治疗组相比，气道正压治疗组的舒张压下降更大（-3.5mmHg 与-1.5mmHg；P=0.07）。在依从气道正压治疗的患者中，这种差异更为显著（-4.4mmHg 与-1.6mmHg；P=0.02）。气道正压治疗组的嗜睡程度显著降低（P<0.0001）。生活质量评估显示，气道正压治疗组的活力、心理健康和心理综合评分均有所改善。
本试验表明，在血糖控制相对较好的 2 型糖尿病合并阻塞性睡眠呼吸暂停患者中，气道正压治疗对血糖控制没有影响。临床试验注册于 www.clinicaltrials.gov（NCT00509223）。
