Sleep stability, weight, and glycemic control

睡眠稳定性、体重和血糖控制

• 批准号: 10678966
• 负责人: BLANDINE B LAFERRERE
• 金额: $ 32.4万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-24 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10678966
• 关键词: Address; Adipose tissue; Adult; Adverse effects; Affect; Age; Area Under Curve; Behavior; Behavior Therapy; Body Composition; Cause of Death; Chronic Disease; Clinical; Clinical Trials; Complications of Diabetes Mellitus; Conduct Clinical Trials; Continuous Glucose Monitor; Data; Diabetes prevention; Diagnosis; Diet; Disease; Drug or chemical Tissue Distribution; Exercise; Fasting; Fatty acid glycerol esters; Fructosamine; Funding Opportunities; Glucose; Glycosylated hemoglobin A; Goals; Health; Heart; Individual; Inflammation; Insulin Resistance; Intervention; Intervention Studies; Life Style; Liver; Magnetic Resonance Imaging; Magnetic Resonance Spectroscopy; Maintenance; Measures; Mediating; Metabolic syndrome; Mission; Modeling; Monitor; Multi-Ethnic Study of Atherosclerosis; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; OGTT; Obesity; Participant; Patients; Physical activity; Plasma; Postmenopause; Prediabetes syndrome; Prevention; Public Health; Randomized; Recommendation; Research; Risk; Risk Factors; Sampling; Schedule; Sleep; Sleep Deprivation; Sleep disturbances; System; Testing; Treatment Efficacy; Visceral; Weight maintenance regimen; Woman; Wrist; actigraphy; blood glucose regulation; blood pressure elevation; clinical practice; design; diabetes management; diet and exercise; disorder risk; fasting glucose; glucose tolerance; glycemic control; improved; improvement on sleep; indexing; innovation; insulin sensitivity; men; modifiable behavior; novel; poor sleep; primary outcome; public health relevance; recruit; research study; secondary outcome; sleep behavior; sleep health; sleep pattern; sleep quality; subcutaneous

Lifestyle changes are at the heart of diabetes prevention and management. In addition to diet and physical activity, sleep has emerged as an important behavior associated with glucose control. Recent studies further show that timing of these behaviors may be as important as their quality and quantity. For example, timing of sleep, independent of sleep duration, has been associated with obesity and metabolic syndrome, particularly glucose concentrations. In support of our study goals, we have shown that reducing variability in bedtimes improves body composition, measured by magnetic resonance imaging, compared to maintaining or increasing bedtime variability in women. While prior sleep research has focused on elucidating adverse health effects of too little sleep or poor sleep quality, we propose an innovative project in which we will test whether improvements in sleep behaviors, namely bedtime stability, ameliorates glycemia. Our main goal is to conduct a pilot clinical intervention study that will test whether reducing bedtime variability improves weight and glycemic control in patients with pre-diabetes. We will recruit men and post-menopausal women, age ³50 y, who have variable bedtimes (VS; standard deviation of bedtimes, measured over 14 d, >60 min). Participants will be randomized to maintain their habitual sleep patterns (VS) or reduce bedtime variability by following a fixed sleep schedule (FS) for 12 wk. Sleep will be monitored nightly using wrist actigraphy. In Aim 1, body adipose tissue distribution will be measured by magnetic resonance imaging (primary outcomes=total, subcutaneous, and visceral adipose tissue) and magnetic resonance spectroscopy (secondary outcome=liver fat). In Aim 2, we will assess glucose tolerance and insulin sensitivity via an oral glucose tolerance test (OGTT) at baseline and endpoint (primary outcome=glucose area under the curve; secondary outcomes=disposition index). Fasting plasma samples at baseline and endpoint will determine long-term glycemia (secondary outcomes=fructosamine and hemoglobin A1c). Finally, in Aim 3, we will assess variability in glucose concentrations, an independent risk factor for diabetes complications, using continuous glucose monitoring system for 14 d prior to study onset and in the last 2 wk of the intervention (primary outcomes=mean amplitude of glycemic excursion and standard deviation of mean glucose; secondary outcome=24-h average glucose concentrations). Diet and physical activity measures will be obtained throughout the intervention. This project has the potential to lead to larger-scale research study to provide more definitive information on the impact of maintaining stable bedtimes as a means to improve the health of adults at risk of type 2 diabetes and improve glycemic control in those living with this disease. This proposal addresses a highly novel and important research question and the

生活方式的改变是糖尿病预防和管理的核心。除了饮食和身体 活动，睡眠已成为与葡萄糖控制相关的重要行为。最近的研究进一步 表明这些行为的时机可能与它们的质量和数量一样重要。例如， 睡眠与睡眠时间无关，与肥胖和代谢综合征有关， 葡萄糖浓度为了支持我们的研究目标，我们已经表明，减少就寝时间的变化， 通过磁共振成像测量，与维持或增加 女性的睡前变化。虽然先前的睡眠研究集中在阐明睡眠对健康的不利影响， 睡眠太少或睡眠质量差，我们提出了一个创新的项目，我们将测试是否改善 睡眠行为，即睡前稳定性，改善睡眠。我们的主要目标是进行临床试验 一项干预性研究，将测试减少睡前变化是否能改善体重和血糖控制， 糖尿病前期患者。我们将招募男性和绝经后女性，年龄为50岁， 就寝时间（VS;就寝时间的标准差，在14天内测量，>60分钟）。受试者将被随机分配 通过遵循固定的睡眠时间表来保持他们的习惯性睡眠模式（VS）或减少就寝时间的变化 (FS)12 wk。将使用腕关节活动记录仪每晚监测睡眠。在目标1中，身体脂肪组织分布 将通过磁共振成像测量（主要结局=总、皮下和内脏脂肪 组织）和磁共振波谱（次要结果=肝脏脂肪）。在目标2中，我们将评估葡萄糖 通过口服葡萄糖耐量试验（OGTT）在基线和终点（主要 结果=葡萄糖曲线下面积;次要结果=处置指数）。空腹血浆样本 基线和终点将决定长期随访（次要结果=果糖胺和血红蛋白 A1c）。最后，在目标3中，我们将评估葡萄糖浓度的变异性，这是一个独立的风险因素， 糖尿病并发症，在研究开始前14天和最后一天使用连续葡萄糖监测系统 干预2周（主要结局=血糖波动的平均幅度和 平均葡萄糖;次要结果=24小时平均葡萄糖浓度）。饮食和体力活动措施 将在整个干预过程中进行。该项目有可能导致更大规模的研究 提供关于维持稳定就寝时间的影响的更明确的信息， 2型糖尿病的风险和改善血糖控制在那些生活与这种疾病的成年人的健康。这 该提案提出了一个非常新颖和重要的研究问题，