Impact of Sleep Extension on Insulin Sensitivity and Dietary Intake in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in Sleep Duration & Timing
研究概览
简要总结
Many teenagers do not get enough sleep. Obesity and diabetes are increasing in teenagers as well. This study plans to learn more about sleep and insulin resistance (insulin not working) in teenagers, and how these things may be related depending on sleep. This is important to know so that the investigators understand how sleep may play a role in health conditions like extra weight gain (increased food intake and less physical activity) and diabetes. To answer this question, the investigators plan to enroll teenagers who get <7 hours of sleep on school nights and measure changes in insulin sensitivity and dietary intake after a week of typical sleep (sleeping on their normal school schedule) and a week of longer sleep (spending 1+ hour longer in bed each night).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High school students between the age of 14-19 years
- •have typically insufficient sleep, defined by ≤ 7 hours per night on school days
- •BMI 5th-84th percentile for age and sex
- •habitually sedentary (< 3 hours of regular physical activity per week)
- •Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.
排除标准
- •Any medications that affect IR or sleep (e.g., metformin, stimulants, atypical antipsychotics, current use of oral steroids)
- •regular use of melatonin or other sleep aids
- •a prior diagnosis of a sleep disorder (e.g. insomnia, delayed sleep phase syndrome, obstructive sleep apnea)
- •Type 2 diabetes or prediabetes
- •IQ<70 or severe mental illness that may impact sleep or ability to consent/assent (e.g., schizophrenia, psychotic episodes)
- •teens not enrolled in a traditional high school academic program (e.g., home school students)
- •schedules that would preclude participants from adhering to the sleep manipulation (e.g. night shift employment)
- •travel across more than two time zones in the 2 weeks prior to the study.
结局指标
主要结局
Change in Sleep Duration & Timing
时间窗: At Baseline, 1 week after Baseline, and 6 weeks after Baseline
Assessed three times with a wrist-worn Actigraphy
Change in Insulin Sensitivity
时间窗: 2 weeks after Baseline and 7 weeks after Baseline
Insulin sensitivity assessed two times with an insulin-modified intravenous glucose tolerance test.
Change in Dietary Intake
时间窗: 1 week after Baseline and 6 weeks after Baseline
Participants will be asked to complete diet diaries two times for 3 days during each sleep condition (prior to each overnight assessment), listing all food and drink consumed, estimated portion size, and timing of consumption.
Change in Physical activity
时间窗: At Baseline, 1 week after Baseline and 6 weeks after Baseline
Assessed three times with a triaxial thigh-worn ActivPal
次要结局
- MTNR1B rs10830963 SNP(2 weeks after Baseline)
- Change in glycemic variability(2 weeks after Baseline and 7 weeks after Baseline)