Night Owl Metabolism

NCT06507722 | Recruiting

• 1 other identifier: IRB00428863
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PreDiabetes; Overweight; Impaired Glucose Tolerance

Keywords

chronotype; sleep

Outcome Measures

Primary Outcomes (3)

• 2-Hour Difference in Glucose

  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.

  Day 4 and Day 11 of Aim 1 derived from OGTT

• Insulin Sensitivity (by Oral Minimal Model)

  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.

  Day 4 and Day 11 of Aim 1 derived from OGTT

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

  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.

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

Secondary Outcomes (13)

• Difference in Fasting Glucose

  Day 4 and Day 11 of Aim 1 obtained before OGTT

• Insulin secretion indices

  Day 4 and Day 11 of Aim 1 derived from OGTT

• Incremental Area Under the Curve (iAUC) for Insulin

  Day 4 and Day 11 of Aim 1 derived from OGTT

• Hemoglobin A1c levels

  Day 4 of Aim 1 during first OGTT Visit

• Difference in Disposition Index

  Day 4 and Day 11 of Aim 1 derived from OGTT

Study Arms (2)

Cohort A - Late Chronotype first, then alternate

OTHER

Sleep onset after 2am

Diagnostic Test: Timing of OGTT; Behavioral: Timing of Standardized Meal

Cohort B - Non-late Chronotype first, then alternate

OTHER

Sleep onset before 11pm

Diagnostic Test: Timing of OGTT; Behavioral: Timing of Standardized Meal

Interventions

Timing of OGTT DIAGNOSTIC_TEST

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

Cohort A - Late Chronotype first, then alternate; Cohort B - Non-late Chronotype first, then alternate

Timing of Standardized Meal BEHAVIORAL

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

Cohort A - Late Chronotype first, then alternate; Cohort B - Non-late Chronotype first, then alternate

Eligibility Criteria

• Age: 18 Years - 23 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Lawson Wilkins Pediatric Endocrine Society: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• DexCom, Inc.: collaborator

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Overweight; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia

Study Officials

• Talia Hitt, MD/MPH/MSHP

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Talia Hitt, MD/MPH/MSHP

CONTACT

860-324-0072; thitt2@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): January 31, 2030
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

US (1)