Night Owl Metabolism

Официальное название

Night Owl Metabolism: Investigating the Impact of Chronotype on Glucose Metabolism in Youth

Обзор

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.

Вмешательства

• Диагностический тест Timing of OGTT
  In Aim 1, timing of oral glucose tolerance test will be altered.
• Поведенческое Timing of Standardized Meal
  In Aim 2, timing of a standardized meal will be altered.

Первичные конечные точки

• 2-Hour Difference in Glucose [Срок оценки: Day 4 and Day 11 of Aim 1 derived from OGTT]
• Insulin Sensitivity (by Oral Minimal Model) [Срок оценки: Day 4 and Day 11 of Aim 1 derived from OGTT]
• 2-hour Incremental Area Under the Curve (iAUC) for glucose [Срок оценки: Day 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal]

Вторичные конечные точки (12)

• Difference in Fasting Glucose [Срок оценки: Day 4 and Day 11 of Aim 1 obtained before OGTT]
• Insulin secretion indices [Срок оценки: Day 4 and Day 11 of Aim 1 derived from OGTT]
• Incremental Area Under the Curve (iAUC) for Insulin [Срок оценки: Day 4 and Day 11 of Aim 1 derived from OGTT]
• Hemoglobin A1c levels [Срок оценки: Day 4 of Aim 1 during first OGTT Visit]
• Difference in Disposition Index [Срок оценки: Day 4 and Day 11 of Aim 1 derived from OGTT]
• Difference in Insulin Clearance [Срок оценки: Day 4 and Day 11 of Aim 1 derived from OGTT]
• Mean Glucose [Срок оценки: Up to 8 days]
• Percent Time Spent Above 120 mg/dL [Срок оценки: Up to 8 days]
• Percent Time Spent Above 140 mg/dL [Срок оценки: Up to 8 days]
• Number of Excursions greater than 140mg/dL [Срок оценки: Up to 8 days]
• Difference in Post-prandial peak [Срок оценки: Day 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal]
• Standard Deviation of Glucose [Срок оценки: Up to 8 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Johns Hopkins School of Medicine — Baltimore

Идентификаторы

NCT: NCT06507722 · IRB00428863

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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