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NCT Number: NCT06507722

Night Owl Metabolism

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.

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Key information

Conditions

PreDiabetes Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Impaired Glucose Tolerance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms

Age range

18 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Talia Hitt, MD/MPH/MSHP

CONTACT

[email protected]

860-324-0072

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. 2-Hour Difference in Glucose

    Time frame: Day 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.

  2. Insulin Sensitivity (by Oral Minimal Model)

    Time frame: 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.

  3. 2-hour Incremental Area Under the Curve (iAUC) for glucose

    Time frame: Day 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.

Secondary outcomes

  1. Difference in Fasting Glucose

    Time frame: Day 4 and Day 11 of Aim 1 obtained before OGTT

    Within-subject difference in fasting glucose at start of 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.

  2. Insulin secretion indices

    Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT

    Within-subject difference in insulin secretion (dynamic phase, static phase, total and insulin secretory rate) from c-peptide 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.

  3. Incremental Area Under the Curve (iAUC) for Insulin

    Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT

    Within-subject difference in iAUC for insulin after glucose ingestion 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.

  4. Hemoglobin A1c levels

    Time frame: Day 4 of Aim 1 during first OGTT Visit

    Analysis of between group differences in hemoglobin A1c levels

  5. Difference in Disposition Index

    Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT

    Within-subject difference in disposition index (derived from insulin sensitivity and insulin secretion metrics) 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.

  6. Difference in Insulin Clearance

    Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT

    Within-subject difference in insulin clearance (derived from Watanabe et al. 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.

  7. Mean Glucose

    Time frame: Up to 8 days

    Analysis of between group differences in mean glucose derived from continuous glucose monitor

  8. Percent Time Spent Above 120 mg/dL

    Time frame: Up to 8 days

    Analysis of between group differences in time spent above 120 mg/dL derived from continuous glucose monitor. Over course of wearing continuous glucose monitor for Aim 2 (8 days)]

  9. Percent Time Spent Above 140 mg/dL

    Time frame: Up to 8 days

    Analysis of between group differences in time spent above 140 mg/dL derived from continuous glucose monitor. Over course of wearing continuous glucose monitor for Aim 2 (8 days).

  10. Number of Excursions greater than 140mg/dL

    Time frame: Up to 8 days

    Analysis of between group differences in the number of excursions above 140 mg/dL derived from continuous glucose monitor. Over course of wearing continuous glucose monitor for Aim 2 (8 days).

  11. Difference in Post-prandial peak

    Time frame: Day 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal

    Within-subject difference in post-prandial peak 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

  12. Standard Deviation of Glucose

    Time frame: Up to 8 days

    Analysis of between group differences in standard deviation of glucose derived from continuous glucose monitor. Over course of wearing continuous glucose monitor for Aim 2 (8 days).

  13. Coefficient of Variation of Glucose

    Time frame: Up to 8 days

    Analysis of between group differences in coefficient of variation of glucose derived from continuous glucose monitor. Over course of wearing continuous glucose monitor for Aim 2 (8 days).

Study contacts

Contact information is provided by the study sponsor or research team.

Talia Hitt, MD/MPH/MSHP

CONTACT

[email protected]

860-324-0072

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • DexCom, Inc.
  • Lawson Wilkins Pediatric Endocrine Society
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Jul 18, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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