Night Owl Metabolism

Johns Hopkins University

Status: Enrolling

Conditions: Impaired Glucose Tolerance; Overweight; PreDiabetes

Treatments: Behavioral: Timing of Standardized Meal; Diagnostic Test: Timing of OGTT

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06507722

IRB00428863

Details and patient eligibility

About

The proposed study uses a novel and rigorous randomized cross-over study design in youth (17-23y) 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 23 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Cohort A - Late Chronotype first, then alternate

Other group

Description:

Sleep onset after 2am

Treatment:

Diagnostic Test: Timing of OGTT

Behavioral: Timing of Standardized Meal

Cohort B - Non-late Chronotype first, then alternate

Other group

Description:

Sleep onset before 11pm

Treatment:

Diagnostic Test: Timing of OGTT

Behavioral: Timing of Standardized Meal