NCT06507722

Night Owl Metabolism

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 23 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• PreDiabetes
• Overweight
• Impaired Glucose Tolerance

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Timing of OGTT	In Aim 1, timing of oral glucose tolerance test will be altered.
BEHAVIORAL	Timing of Standardized Meal	In Aim 2, timing of a standardized meal will be altered.

Timeline

• Start date: 2025-02-25
• Primary completion: 2029-12-31
• Completion: 2030-01-31
• First posted: 2024-07-18
• Last updated: 2025-06-04

Locations

1 site across 1 country: United States