Clinical trial

Night Owl Metabolism

Recruiting now · Not applicable · 1 countries · Registry ID NCT06507722

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 23 Years

SexAll

Healthy volunteersAccepted

ConditionPreDiabetes, Overweight, Impaired Glucose Tolerance

Full registry criteria

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.

Treatments and study arms

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.

Primary outcomes

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.

Study locations

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Johns Hopkins School of Medicine🇺🇸 Baltimore, Maryland, United States

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Talia Hitt, MD/MPH/MSHPContact

Email · Call 860-324-0072