About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Timing of OGTT
- Timing of Standardized Meal
Treatment groups
Sponsors and collaborators
Johns Hopkins University
Lead sponsor
Lawson Wilkins Pediatric Endocrine Society
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
DexCom, Inc.
Collaborator