Night Owl Metabolism

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06507722
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 23 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 25, 2025
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Other: Cohort A - Late Chronotype first, then alternate
    Sleep onset after 2am
  • Other: Cohort B - Non-late Chronotype first, then alternate
    Sleep onset before 11pm

Primary Outcome Measure

2-Hour Difference in Glucose [ Time Frame: Day 4 and Day 11 of Aim 1 derived from OGTT ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins School of MedicineBaltimoreMaryland21287
Talia Hitt, MD/MPH/MSHP
[email protected]
860-324-0072

Find similar trials in Baltimore, MD

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Johns Hopkins School of Medicine· Baltimore, MD

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