Night Owl Metabolism: Investigating the Impact of Chronotype on Glucose Metabolism in Youth
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- 2-Hour Difference in Glucose
研究概览
简要总结
The proposed study uses a novel and rigorous randomized cross-over study design in youth (18-23y) with late and non-late chronotype (n=35 per group) to assess the glycemic effect of "aligning" an oral glucose tolerance test (OGTT) or first-meal of day to a subject's chronotype. Both groups will undergo 2 OGTTs (aligned and mis-aligned with chronotype) to compare glucose tolerance and insulin sensitivity within-subject (primary outcome) and between groups (Aim 1). Then, youth will also undergo two standardized meals (aligned and mis-aligned with chronotype) while wearing continuous glucose monitoring to compare post-prandial glucose excursions within-subject and between groups (Aim 2). A pilot Exploratory Aim 3 (n=12 per group) will investigate delayed melatonin patterns under dim-light as a potential pathophysiologic mechanism behind abnormal glucose tolerance in youth with late chronotype on morning OGTTs.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Randomization will be done via a computer-generated random number list prepared by the statistician who will have no clinical involvement in the study. The list will then be provided to the study coordinator. The investigator will not be masked to assignment for Aim 1 as the investigator will be available during OGTT testing as needed. In Aim 2, the investigator will be blinded to randomization.
入排标准
- 年龄范围
- 18 Years 至 23 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight similar to (BMI ≥ 85th percentile but <95th percentile for age and sex per Centers for Disease Control and Prevention growth curves (as Centers for Disease Control and Prevention growth curves contain ages ≤ 20y; if ages 21-23 years, the BMI ≥ 85th and <95th percentile equivalents for a 20-year-old will be used))
- •Post-pubertal
- •Normal sleep duration (avg. >7 hours of sleep per night)
- •Social jetlag (difference between weekend and weekday sleep) of < 2 hours.
排除标准
- •Known diabetes, sleep disorders, major organ system illness, pregnancy, or genetic syndrome
- •Medication use known to affect insulin sensitivity, glucose tolerance, or circadian rhythm
- •Screening high risk for obstructive sleep apnea
- •Night shift work.
研究组 & 干预措施
Cohort A - Late Chronotype first, then alternate
Sleep onset after 2am
干预措施: Timing of OGTT (Diagnostic Test)
Cohort A - Late Chronotype first, then alternate
Sleep onset after 2am
干预措施: Timing of Standardized Meal (Behavioral)
Cohort B - Non-late Chronotype first, then alternate
Sleep onset before 11pm
干预措施: Timing of OGTT (Diagnostic Test)
Cohort B - Non-late Chronotype first, then alternate
Sleep onset before 11pm
干预措施: Timing of Standardized Meal (Behavioral)
结局指标
主要结局
2-Hour Difference in Glucose
时间窗: Day 4 and Day 11 of Aim 1 derived from OGTT
Within-subject difference in 2-hour glucose after glucose ingestion on OGTT between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.
Insulin Sensitivity (by Oral Minimal Model)
时间窗: Day 4 and Day 11 of Aim 1 derived from OGTT
Within-subject difference in insulin sensitivity (derived from oral Minimal Model) between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.
2-hour Incremental Area Under the Curve (iAUC) for glucose
时间窗: Day 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal
Within-subject difference in iAUC for glucose from continuous glucose monitor between early and late Meal (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late Meal.
次要结局
- Mean Glucose(Up to 8 days)
- Difference in Disposition Index(Day 4 and Day 11 of Aim 1 derived from OGTT)
- Difference in Post-prandial peak(Day 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal)
- Difference in Fasting Glucose(Day 4 and Day 11 of Aim 1 obtained before OGTT)
- Insulin secretion indices(Day 4 and Day 11 of Aim 1 derived from OGTT)
- Number of Excursions greater than 140mg/dL(Up to 8 days)
- Incremental Area Under the Curve (iAUC) for Insulin(Day 4 and Day 11 of Aim 1 derived from OGTT)
- Hemoglobin A1c levels(Day 4 of Aim 1 during first OGTT Visit)
- Difference in Insulin Clearance(Day 4 and Day 11 of Aim 1 derived from OGTT)
- Coefficient of Variation of Glucose(Up to 8 days)
- Percent Time Spent Above 120 mg/dL(Up to 8 days)
- Percent Time Spent Above 140 mg/dL(Up to 8 days)
- Standard Deviation of Glucose(Up to 8 days)