Metabolic Effects of Sleep Extension in People With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Insulin Sensitivity
研究概览
简要总结
This study is designed to determine the impact of extending sleep duration on glucose metabolism in people with obesity. Half of the participants will be instructed to increase their time-in-bed in order to achieve >7h sleep/night (sleep extension; n=15) while the other half will be be instructed to maintain their current sleep habits (n=15).
详细描述
Restricting sleep is known to be detrimental to glucose metabolism in healthy adults. Obesity is a condition associated with both lower sleep duration and poor glucose tolerance. Therefore, increasing sleep duration is a potentially novel therapeutic strategy for improving glucose metabolism in this population. The investigators will assess this by determining insulin sensitivity during a hyperinsulinemic-euglycemic clamp before and after a sleep intervention in both the control and sleep extension groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sleep <7h/night
- •Body mass index 25-50 kg/m2
- •Altered glucose metabolism (any of the following) Fasting glucose 100-125 mg/dL or, 2-h plasma glucose 140-199 mg/dL during an oral glucose tolerance test (OGTT) or, HbA1c 5.7-6.4% or, homeostatic model assessment of insulin resistance (HOMA-IR) ≥2.0
排除标准
- •Sleep disorders
- •moderate to severe sleep apnea (apnea-hypopnea index ≥15 events/hour)
- •had ≥15 periodic limb movements per hour sleep [PLMS]
- •narcolepsy or insomnia
- •Perform shift work
- •Excessive caffeine or alcohol consumption
- •Significant organ dysfunction/disease (e.g. diabetes mellitus, kidney disease)
- •Liver disease other than metabolic dysfunction associated steatotic liver disease (MASLD)
- •Prior bariatric surgery
- •Pregnancy or breastfeeding
- •Taking medications that can affect study outcomes (alter sleep duration or glucose metabolism)
- •Tobacco or illicit drug use
- •Perform intense exercise >70 min/wk or moderate exercise >150 min/week
- •Excessive alcohol consumption (>21 units of alcohol per week for men and >14 units of alcohol per week for women)
结局指标
主要结局
Insulin Sensitivity
时间窗: Change from baseline testing after 4-6 weeks of intervention
Whole-body insulin sensitivity calculated as the insulin stimulated rate of glucose disposal per kilogram of fat-free body mass (µmol/kgFFM/min) during a hyperinsulinemic-euglycemic clamp.
Insulin Sensitivity
时间窗: Change from baseline testing after 4-6 weeks of intervention
Whole-body insulin sensitivity calculated as the insulin stimulated rate of glucose disposal per kilogram of fat-free body mass (µmol/kgFFM/min) during a hyperinsulinemic-euglycemic clamp.
次要结局
- 24 Hour Glucose Area Under the Concentration Curve(Change from baseline testing after 4-6 weeks of intervention)
- 24 Hour Insulin Area Under the Concentration Curve(Change from baseline testing after 4-6 weeks of intervention)
- 24 Hour Non-esterified Fatty Acids Area Under the Concentration Curve(Change from baseline testing after 4-6 weeks of intervention)
- Fasting Glucose(Change from baseline testing after 4-6 weeks of intervention)
- Daily Time in Bed(Change from baseline testing after 4-6 weeks of intervention)
- Hepatic Insulin Sensitivity Index(Change from baseline testing after 4-6 weeks of intervention)
- Daily Total Sleep Time(Change from baseline testing after 4-6 weeks of intervention)
- Stage N1 Sleep Time(Change from baseline testing after 4-6 weeks of intervention)
- Stage N2 Sleep Time(Change from baseline testing after 4-6 weeks of intervention)
- Stage N3 Sleep Time(Change from baseline testing after 4-6 weeks of intervention)
- Rapid Eye Movement (REM) Sleep Time(Change from baseline testing after 4-6 weeks of intervention)
- Adipose Tissue Insulin Sensitivity Index(Change from baseline testing after 4-6 weeks of intervention)
- Homeostatic Model Assessment of Insulin Resistance(Change from baseline testing after 4-6 weeks of intervention)
- Body Mass(Change from baseline testing after 4-6 weeks of intervention)
- Liver Fat(Change from baseline testing after 4-6 weeks of intervention)
- Fat-free Mass(Change from baseline testing after 4-6 weeks of intervention)
- Body Fat(Change from baseline testing after 4-6 weeks of intervention)