Night Owl Metabolism Study for Prediabetes and Overweight Youth

This study, called "Night Owl Metabolism," is looking at how the timing of meals and glucose tests affects blood sugar in young people (ages 18-23) who are overweight or have prediabetes. Researchers want to see if aligning these timings with a person's natural sleep-wake cycle (chronotype) can improve how their body handles sugar. You would undergo two types of tests: an oral glucose tolerance test (OGTT), which measures how your body processes sugar, and standardized meals. The study aims to see if changing the timing of these interventions improves blood sugar levels and insulin sensitivity (how well your body uses insulin to control blood sugar). The study is currently recruiting about 70 participants.

Study design
This is a randomized cross-over study involving about 70 participants, divided into two groups based on their chronotype (late or non-late). Each participant will experience both aligned and misaligned timings for tests and meals.
What's involved
You would undergo two oral glucose tolerance tests and two standardized meals. Continuous glucose monitoring will be used during the standardized meals.
Compensation
Not stated in the trial record.
Follow-up
Blood sugar and insulin sensitivity will be measured on Day 4 and Day 11 for the oral glucose tolerance tests, and during the post-meal period on Day 1 and Day 8 for the standardized meals.

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NCT06507722

Night Owl Metabolism

Recruiting
NAAges 18–23InterventionalPrevention
Johns Hopkins University
~70 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:Timing of OGTTTiming of Standardized Meal

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
2-Hour Difference in Glucose
Measured over Day 4 and Day 11 of Aim 1 derived from OGTT
+2 more outcomes measured
PreDiabetes
Overweight
Impaired Glucose Tolerance
1 sites across 1 states
Maryland1
  • Talia Hitt, MD/MPH/MSHP · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

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Eligibility criteria

Inclusion

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

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.
  • 2-Hour Difference in GlucoseDay 4 and Day 11 of Aim 1 derived from OGTT

    Within-subject difference in 2-hour glucose after glucose ingestion on OGTT between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.

  • Insulin Sensitivity (by Oral Minimal Model)Day 4 and Day 11 of Aim 1 derived from OGTT

    Within-subject difference in insulin sensitivity (derived from oral Minimal Model) between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.

  • 2-hour Incremental Area Under the Curve (iAUC) for glucoseDay 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal

    Within-subject difference in iAUC for glucose from continuous glucose monitor between early and late Meal (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late Meal.