Sleep for Health: A randomized clinical trial examining the effects of cognitive behavioral therapy for insomnia on diabetes risk

睡眠有益健康：一项随机临床试验，研究认知行为疗法治疗失眠对糖尿病风险的影响

• 批准号: 10587569
• 负责人: ERIN S LEBLANC
• 金额: $ 70.28万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10587569
• 关键词: Adult; Affect; American; Amputation; Behavioral; Blindness; Blood Glucose; Blood specimen; Body Weight decreased; Cardiovascular Diseases; Cell physiology; Cessation of life; Chronic; Clinical; Cognitive Therapy; Continuous Glucose Monitor; Data; Diabetes Mellitus; Diabetes prevention; Diagnosis; Diet; Eating; Educational Materials; Educational workshop; Equilibrium; Exercise; Feasibility Studies; Future; Glucose; Glycosylated hemoglobin A; Guidelines; Health; Health system; Healthy Eating; Heterogeneity; Hour; Hydrocortisone; Hyperglycemia; Individual; Inflammation; Insulin Resistance; Intake; Intervention; Intervention Studies; Kidney Failure; Laboratory Study; Measures; Mediating; Metabolic; Modeling; Moods; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; OGTT; Obesity; Outcome; Pancreas; Participant; Pathway interactions; Patient Education; Patients; Persons; Physical activity; Physiological; Pilot Projects; Population; Population Study; Prediabetes syndrome; Prevalence; Quality of life; Randomized; Research; Rewards; Risk; Risk Factors; Sampling; Sleep; Sleep Deprivation; Sleep Disorders; Sleep disturbances; Sleeplessness; Testing; Time; United States; Weight Gain; Work; adipokines; anxiety symptoms; arm; clinically significant; depressive symptoms; diabetes risk; digital; energy density; evidence base; fasting glucose; food craving; glucose tolerance; improved; improvement on sleep; indexing; intervention effect; moderate-to-vigorous physical activity; modifiable risk; poor sleep; premature; prevent; primary outcome; programs; randomized, clinical trials; recruit; restoration; secondary outcome; sedentary; sleep health; sleep onset; sleep quality; standard of care; stem; tool; treatment arm; trend; web site

PROJECT SUMMARY/ABSTRACT Type 2 diabetes mellitus (T2D) is a major cause of blindness, kidney failure, cardiovascular disease, amputations, reduced quality of life, and premature death in the United States, and it is expected that one in three Americans will have T2D by 2050. To stem the tide of this health crisis, new strategies are needed to prevent the progression to T2D from prediabetes—elevated glucose levels that are not yet in the diabetes range. A growing body of research suggests that insomnia is a major modifiable risk factor for progression to diabetes. The proposed study would build off a promising feasibility study to test whether providing cognitive behavioral therapy for insomnia (CBT-I) to patients with prediabetes results in a reduction in glucose levels compared to a patient education control program. If so, this insomnia treatment could be an effective tool to prevent diabetes. Individuals with prediabetes and insomnia will be randomized to receive six sessions of a deployment-ready digital CBT-I program, providing standard-of-care treatment for insomnia (intervention arm, n = 150), or a patient education website providing nontailored educational material about insomnia (control arm, n = 150). We will complete assessments at baseline, at 10 weeks (after the conclusion of the intervention and control programs), and at 32 weeks post-baseline, measuring hyperglycemia, objective and subjective measures of sleep, and potential mediating variables including diet, exercise, and mood. We will also collect and store blood samples to allow for assessment of metabolic mechanisms in future research. We will assess (1) whether individuals randomized to the intervention arm have lower rates of hyperglycemia, as measured by oral glucose tolerance testing and various secondary measures, than individuals randomized to the control arm at 10 weeks and 32 weeks after baseline; (2) whether improvements in sleep after baseline are associated with decreases in hyperglycemia, regardless of study arm; and (3) whether any effects of the intervention on hyperglycemia are mediated by improvements in sleep, diet, exercise, and/or mood. This research will serve as a critical step in identifying a potentially dramatic tool for improving health outcomes for Americans at risk of T2D. Sleep interventions can lead to sustained improvements that are intrinsically rewarding to patients. If effective, digital CBT-I could provide a powerful pathway to preventing diabetes for millions of patients with prediabetes.

项目总结/摘要 2型糖尿病（T2 D）是失明、肾衰竭、心血管疾病、 截肢，生活质量下降，过早死亡，预计在美国， 到2050年将有三个美国人患有T2 D。为了遏制这一健康危机的浪潮，需要采取新的战略， 防止从糖尿病前期进展为T2 D-尚不属于糖尿病的血糖水平升高 范围越来越多的研究表明，失眠是一个主要的可改变的危险因素， 糖尿病拟议的研究将建立一个有前途的可行性研究，以测试是否提供认知 对糖尿病前期患者进行失眠行为疗法（CBT-I）可降低血糖水平 与病人教育控制计划相比。如果是这样，这种失眠治疗方法可能是一种有效的工具， 预防糖尿病。 患有前驱糖尿病和失眠症的个体将被随机分配接受六次部署就绪的 数字CBT-I计划，提供失眠的标准治疗（干预组，n = 150），或 患者教育网站提供关于失眠的非定制教育材料（对照组，n = 150）。 我们将在基线、第10周（干预和对照结束后）完成评估 程序），并在基线后32周，测量高血糖症，客观和主观测量 睡眠，以及潜在的中介变量，包括饮食，运动和情绪。我们还将收集和储存 血液样本，以便在未来的研究中评估代谢机制。 我们将评估（1）随机分配到干预组的个体是否具有较低的 通过口服葡萄糖耐量试验和各种次级测量测量， 在基线后10周和32周随机分配至对照组的个体;（2）是否 基线后睡眠改善与高血糖降低相关，无论研究 （3）干预对高血糖症的任何影响是否通过改善 睡眠、饮食、锻炼和/或情绪。 这项研究将成为确定改善健康的潜在戏剧性工具的关键一步 美国T2 D风险的结果。睡眠干预可以导致持续的改善， 对患者有内在的回报。如果有效，数字CBT-I可以提供一个强大的途径， 糖尿病患者的生活质量。