Night Owl Metabolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-25

Study Completion Date

2030-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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PreDiabetes Overweight Impaired Glucose Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

For randomization in Aim 1, participants will be assigned to Early or Late OGTT for the first visit with crossover to the alternate for the second visit. In Aim 2, participants will be assigned to Early or Late standardized first meal for Day 1 with crossover to the alternate for Day 8.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Randomization will be done via a computer-generated random number list prepared by the statistician who will have no clinical involvement in the study. The list will then be provided to the study coordinator. The investigator will not be masked to assignment for Aim 1 as the investigator will be available during OGTT testing as needed. In Aim 2, the investigator will be blinded to randomization.

Study Groups

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Cohort A - Late Chronotype first, then alternate

Sleep onset after 2am

Group Type OTHER

Timing of OGTT

Intervention Type DIAGNOSTIC_TEST

In Aim 1, timing of oral glucose tolerance test will be altered.

Timing of Standardized Meal

Intervention Type BEHAVIORAL

In Aim 2, timing of a standardized meal will be altered.

Cohort B - Non-late Chronotype first, then alternate

Sleep onset before 11pm

Group Type OTHER

Timing of OGTT

Intervention Type DIAGNOSTIC_TEST

In Aim 1, timing of oral glucose tolerance test will be altered.

Timing of Standardized Meal

Intervention Type BEHAVIORAL

In Aim 2, timing of a standardized meal will be altered.

Interventions

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Timing of OGTT

In Aim 1, timing of oral glucose tolerance test will be altered.

Intervention Type DIAGNOSTIC_TEST

Timing of Standardized Meal

In Aim 2, timing of a standardized meal will be altered.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes