The Effect of Treatment of OSA on Diabetes Self Management and Glycemic Control

OSA 治疗对糖尿病自我管理和血糖控制的影响

• 批准号: 9293302
• 负责人: Eileen R Chasens
• 金额: $ 53.26万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-15 至 2019-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9293302
• 关键词: Accelerometer; Adherence; Adult; Affect; Age; Apnea; Behavior; Behavior Therapy; Behavioral; Conflict (Psychology); Continuous Positive Airway Pressure; Counseling; Data; Data Analyses; Diabetes Mellitus; Distress; Dose; Double-Blind Method; Drowsiness; Education; Effectiveness of Interventions; Enrollment; Excessive Daytime Sleepiness; Fatigue; Feasibility Studies; Female; General Population; Goals; Guidelines; Health; High Prevalence; Impairment; Knowledge; Lead; Life Style; Measures; Mediating; Medical; Minority; Monitor; Moods; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Obstructive Sleep Apnea; Outcome; Outcome Measure; Patient Self-Report; Persons; Physical activity; Physiological; Pilot Projects; Placebo Control; Population; Prevalence; Randomized; Recruitment Activity; Reporting; Research Personnel; Resistance; Sampling; Secondary to; Self Management; Severities; Sleep; Sleep Apnea Syndromes; Sleep disturbances; Testing; Therapeutic; active method; blood glucose regulation; compare effectiveness; diabetes control; diabetes education; diabetes management; effective therapy; efficacy testing; functional outcomes; glycemic control; improved; indexing; neurobehavioral; public health relevance; randomized placebo controlled trial; screening; sedentary lifestyle; treatment effect; vigilance

DESCRIPTION (provided by applicant): While diabetes self-management has been improved and refined over the last 30 years, many persons with T2DM continue to have difficulty in achieving glycemic goals. Obstructive sleep apnea (OSA) has a high prevalence among adults with type 2 diabetes (T2DM) and is associated with excessive daytime sleepiness, impaired mood, decreased vigilance, and reduced functional outcomes. The degree that OSA affects diabetes self-management, a known determinant of glycemic control, remains unstudied. The most effective treatment for OSA, continuous positive airway pressure (CPAP), results in improved self-reported daytime functioning. However, the effect of CPAP treatment on reception of diabetes education remains unknown. The underlying premise of the proposed study from this new investigator is that OSA hinders diabetes self-management in adults with T2DM. This study expands on our pilot/feasibility study that suggested that CPAP treatment is associated with decreased fatigue, increased physical activity, and improved glucose control. Our goal is to improve understanding of the effect of OSA on diabetes self-management and to determine the efficacy of CPAP treatment in improving diabetes outcomes in adults treated with CPAP compared to those on sham- CPAP. We propose to enroll 210 adults (50 percent female; 40 percent minority) with T2DM and moderate-to-severe OSA (apnea + hypopnea index > 15) who have suboptimal glycemic control (A1C e 7.0 percent) for a double blind, randomized, placebo-controlled trial to determine if diabetes self-management outcomes and glycemic control are better in subjects with OSA who are treated with CPAP and receive diabetes education and counseling compared to control subjects who are on sham-CPAP and receive diabetes education. We will compare the effectiveness of the intervention after 6 weeks and 12 weeks on measures of glycemic control, retention of information taught during the diabetes education sessions, lifestyle behaviors required for optimal diabetes control, reported monitoring of self-management activities, physical activity, and diabetes-related distress. We will explore whether the average nighttime use (adherence) of CPAP, sleep quality, daytime sleepiness, mood, and vigilance mediate the effect of CPAP treatment on glycemic control and diabetes self-management outcomes. We will also explore if adherence to CPAP is associated with outcome measures of glycemic control and lifestyle behaviors in the entire sample after 24 weeks of therapeutic CPAP. This study uses objective measures to measure CPAP adherence, physical activity, vigilance, and glycemic control. After 12-weeks, subjects who were originally on sham-CPAP will be crossed over to active treatment. The overall impact of this study will be increased knowledge about the effect of sleep apnea on diabetes self-management. Expanding our understanding of the effect of sleep disturbances on diabetes self-management may lead to improved guidelines for screening and treatment of OSA in the increasingly large portion of the population with diabetes.

描述(申请人提供)：尽管糖尿病的自我管理在过去30年中得到了改善和完善，但许多T2 DM患者在实现血糖目标方面仍然存在困难。阻塞性睡眠呼吸暂停(OSA)在成人2型糖尿病(T2 DM)中有很高的患病率，并与白天过度嗜睡、情绪受损、警觉性降低和功能结果降低有关。OSA对糖尿病自我管理的影响程度仍未得到研究，糖尿病自我管理是血糖控制的已知决定因素。阻塞性睡眠呼吸暂停最有效的治疗方法是持续气道正压(CPAP)，可改善自我报告的日间功能。然而，CPAP治疗对接受糖尿病教育的影响仍不清楚。这位新研究者提出的这项研究的基本前提是，OSA阻碍了成年T2 DM患者的糖尿病自我管理。这项研究扩展了我们的试点/可行性研究，表明CPAP治疗与减少疲劳、增加体力活动和改善血糖控制有关。我们的目标是更好地了解OSA对糖尿病自我管理的影响，并确定与Sham-CPAP相比，CPAP治疗在改善接受CPAP治疗的成年人糖尿病预后方面的有效性。我们建议招募210名患有T2 DM和中到重度OSA(呼吸暂停+低通气指数)、血糖控制不佳(A1Ce 7.0%)的成年人(女性占50%；少数民族占40%)，进行一项双盲、随机、安慰剂对照试验，以确定接受CPAP治疗并接受糖尿病教育和咨询的OSA受试者，与接受假CPAP并接受糖尿病教育的对照组受试者相比，糖尿病自我管理结果和血糖控制是否更好。我们将在6周和12周后比较干预措施的有效性，包括血糖控制措施、在糖尿病教育会议期间传授的信息的保留、最佳糖尿病控制所需的生活方式行为、报告的自我管理活动监测、体力活动和糖尿病相关痛苦。我们将探讨夜间平均使用(坚持)CPAP、睡眠质量、日间困倦、情绪和警觉性是否在CPAP治疗对血糖控制和糖尿病自我管理结果的影响中起中介作用。我们还将探索在治疗性CPAP治疗24周后，整个样本中坚持CPAP是否与血糖控制和生活方式行为的结果指标相关。这项研究使用客观的方法来衡量CPAP的依从性、体力活动、警觉性和血糖控制。12周后，最初接受假CPAP治疗的受试者将被转移到积极治疗。这项研究的总体影响将是增加对睡眠呼吸暂停对糖尿病自我管理影响的了解。扩大我们对睡眠障碍对糖尿病自我管理的影响的了解，可能会导致在越来越多的糖尿病人口中改进OSA的筛查和治疗指南。