Sleep stability, weight, and glycemic control

睡眠稳定性、体重和血糖控制

基本信息

批准号：
10363984
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
项目类别：
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/10363984
关键词：
Address Adipose tissue Adult Adverse effects Affect Age Area Under Curve Behavior Behavior Therapy Blood Pressure Body Composition Cause of Death Chronic Disease Clinical Clinical Trials Complications of Diabetes Mellitus Conduct Clinical Trials Data Diabetes Mellitus Diabetes prevention Diagnosis Diet Disease Drug or chemical Tissue Distribution Fasting Fatty acid glycerol esters Fructosamine Funding Opportunities Glucose Glycosylated hemoglobin A Goals Health Heart Individual Insulin Resistance Intervention Intervention Studies Lead 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 System Testing Time Treatment Efficacy Visceral Weight maintenance regimen Woman Wrist actigraphy base blood glucose regulation clinical practice design diabetes management diet and exercise disorder risk fasting glucose glucose monitor glucose tolerance glycemic control improved 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

项目摘要

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

除了饮食和身体健康之外，生活方式的改变也是糖尿病预防和管理的核心。活动、睡眠已成为与血糖控制相关的重要行为。表明这些行为的时机可能与其质量和数量一样重要，例如，行为的时机。睡眠，与睡眠时间无关，与肥胖和代谢综合征有关，尤其是为了支持我们的研究目标，我们已经证明可以减少就寝时间的变化。与维持或增加相比，通过磁共振成像测量可以改善身体成分女性就寝时间的变化虽然之前的睡眠研究重点是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项目，我们将测试是否有改善我们的主要目标是进行临床试验。干预研究将测试减少就寝时间变化是否可以改善体重和血糖控制我们将招募男性和绝经后女性，年龄≥50岁，患有不同程度的糖尿病前期的患者。就寝时间（VS；就寝时间的标准差，测量超过 14 天，>60 分钟）。通过遵循固定的睡眠时间表来维持习惯性睡眠模式 (VS) 或减少就寝时间的变化 (FS) 12 周，每晚使用腕部活动记录仪监测睡眠。目标 1：身体脂肪组织分布。将通过磁共振成像进行测量（主要结果=总脂肪、皮下脂肪和内脏脂肪）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。通过基线和终点（主要结果=曲线下的血糖面积；次要结果=处置指数）。基线和终点将决定长期血糖（次要结果=果糖胺和血红蛋白最后，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，在研究开始前和最后 14 天使用连续血糖监测系统干预 2 周（主要结果 = 血糖波动的平均幅度和血糖波动的标准差平均血糖；次要结果=24 小时平均血糖浓度）。该项目有可能导致更大规模的研究。提供关于保持稳定的就寝时间作为改善睡眠的一种手段的影响的更明确的信息有 2 型糖尿病风险的成年人的健康，并改善患有这种疾病的人的血糖控制。提案解决了一个非常新颖且重要的研究问题