正压通气治疗对 2 型糖尿病合并阻塞性睡眠呼吸暂停患者血糖变异性的影响：一项随机对照试验。
Effects of Positive Airway Pressure Therapy on Glycemic Variability in Patients With Type 2 Diabetes and OSA: A Randomized Controlled Trial.
机构信息
Division of Pulmonary, Critical Care, and Sleep Medicine, NYU Grossman School of Medicine, New York, NY.
Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD.
出版信息
Chest. 2023 Oct;164(4):1057-1067. doi: 10.1016/j.chest.2023.04.017. Epub 2023 Apr 14.
BACKGROUND
Glycemic variability is associated with increased risk for cardiovascular disease in patients with type 2 diabetes independent of glycosylated hemoglobin A1c (HbA1c) levels. Given the conflicting evidence on the effect of positive airway pressure (PAP) therapy for OSA on HbA1c, elucidating its effect on glycemic variability has value.
RESEARCH QUESTION
Does the use of PAP therapy for OSA improve glycemic variability in patients with type 2 diabetes?
STUDY DESIGN AND METHODS
A randomized controlled trial was conducted in 184 patients with type 2 diabetes and moderate-to-severe OSA. Participants received either 3 months of PAP therapy with lifestyle counseling or lifestyle counseling alone. End points included the SD of glucose levels along with other metrics derived from continuous glucose monitoring and self-monitoring of blood glucose.
RESULTS
No differences were noted in either primary or secondary continuous glucose monitoring end points between the two groups. Average use of PAP therapy was 5.4 h/night (SD, 1.6). Exploratory analyses by sex showed significant differences in the primary and secondary outcomes. In female participants, PAP therapy was associated with improvement in the SD of glucose levels, with a mean difference in change between intervention and control groups of 3.5 mg/dL (P = .02). PAP therapy was also associated with lower post-dinner and bedtime glucose levels: 20.1 mg/dL (P < .01) and 34.6 mg/dL (P < .01), respectively.
INTERPRETATION
PAP therapy did not improve glycemic control or variability in patients with moderate-to-severe OSA and type 2 diabetes. Exploratory analyses suggested that PAP therapy may improve glucose variability in female participants. Post-dinner and bedtime glucose levels were higher in those who did not receive PAP therapy.
TRIAL REGISTRATION
ClinicalTrials.gov; No.: NCT02454153; URL: www.
CLINICALTRIALS
gov.
背景
血糖变异性与 2 型糖尿病患者心血管疾病风险增加有关，而与糖化血红蛋白 A1c（HbA1c）水平无关。鉴于正压通气（PAP）治疗阻塞性睡眠呼吸暂停（OSA）对 HbA1c 的影响存在矛盾证据，阐明其对血糖变异性的影响具有价值。
研究问题
PAP 治疗 OSA 是否改善 2 型糖尿病患者的血糖变异性？
研究设计和方法
一项随机对照试验纳入了 184 例患有 2 型糖尿病和中重度 OSA 的患者。参与者接受 3 个月的 PAP 治疗联合生活方式咨询或仅接受生活方式咨询。终点包括连续血糖监测和自我血糖监测得出的血糖水平标准差等其他指标。
结果
两组间主要或次要连续血糖监测终点均无差异。平均 PAP 治疗时间为 5.4 小时/夜（标准差，1.6）。按性别进行的探索性分析显示主要和次要结局存在显著差异。在女性参与者中，PAP 治疗与血糖水平标准差的改善相关，干预组与对照组之间的平均差值为 3.5mg/dL（P=0.02）。PAP 治疗还与晚餐后和睡前血糖水平降低相关：分别为 20.1mg/dL（P<0.01）和 34.6mg/dL（P<0.01）。
解释
PAP 治疗并未改善中重度 OSA 和 2 型糖尿病患者的血糖控制或变异性。探索性分析表明，PAP 治疗可能改善女性参与者的血糖变异性。未接受 PAP 治疗的患者晚餐后和睡前的血糖水平较高。
试验注册
ClinicalTrials.gov；编号：NCT02454153；网址：www.clinicaltrials.gov。
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