Home Sleep and Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Change from Baseline in insulin sensitivity (SI)
研究概览
简要总结
Bedtimes and wake-up times vary from person to person. The aim of this research is to examine the associations between sleep habits and metabolism in healthy people. In this study, the investigators will collect information on sleep-wake habits and how the body uses energy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 21-40 years
- •Body mass index: 25.0 to 29.9 kg/m2
- •Average habitual sleep duration of 6.5 hours or less per night (as confirmed by actigraphy)
- •stable sleep habits for the past 6 months
排除标准
- •obstructive sleep apnea or history of any other sleep disorder
- •night or rotating shift work (current or in the past 2 years)
- •habitual daytime naps
- •recent (< 4 week) travel across time zones
- •extreme chronotypes
- •any acute or chronic medical condition
- •prior or current eating or psychiatric disorders
- •claustrophobia
- •irregular menstrual periods, menopause, pregnancy,
- •alcohol abuse, excessive caffeine intake, smoking, illegal drug use
- •subjects who are currently following a weight loss regimen or any other special diet or exercise programs
- •subjects who have received iv or oral contrast in the past 2 weeks
- •use of any prescription medication that can affect sleep or metabolism with the exception of antihypertensive and lipid lowering agents as follows. Subjects who are taking anti-hypertensive medication and/or lipid-lowering agents will be included only if they are well controlled and on a stable regimen (no change in medications in the previous 3 months). However, beta-blockers and thiazide diuretics will not be allowed, as these medications are known to affect insulin sensitivity. Women will be required to not be on hormone replacement therapy.
结局指标
主要结局
Change from Baseline in insulin sensitivity (SI)
时间窗: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
Insulin sensitivity will be derived from minimal model analysis of mixed meal tolerance test. The mixed meal tolerance test is performed at the end of the first 2-week period and at the end of the second 2-week period. For each subject, the change from the first 2-week period in insulin sensitivity will be calculated.
Change from Baseline in disposition index
时间窗: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
Disposition index will be derived from minimal model analysis of mixed meal tolerance test. The mixed meal tolerance test is performed at the end of the first 2-week period and at the end of the second 2-week period. For each subject, the change from the first 2-week period in disposition index will be calculated.
Change from Baseline in total energy expenditure
时间窗: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
Total energy expenditure will be derived from doubly labeled water method. For each subject, total energy expenditure will be calculated during each 2-week period and then the change from the first 2-week period in total energy expenditure will be calculated.
Change from Baseline in energy intake
时间窗: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
Energy intake will be derived from doubly labeled water method and body composition analysis. For each subject, energy intake will be calculated during each 2-week period and then the change from the first 2-week period in energy intake will be calculated.
Change from Baseline in beta-cell function
时间窗: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
Beta cell function will be derived from minimal model analysis of mixed meal tolerance test. The mixed meal tolerance test is performed at the end of the first 2-week period and at the end of the second 2-week period. For each subject, the change from the first 2-week period in beta-cell function will be calculated.
次要结局
- Change from Baseline in body weight(The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.)