RECRUITING

Night Owl Metabolism

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-01
Study Completion:2030-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06507722

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 23 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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))
  2. * Post-pubertal
  3. * Normal sleep duration (avg. \>7 hours of sleep per night)
  4. * Social jetlag (difference between weekend and weekday sleep) of \< 2 hours.
  1. * Known diabetes, sleep disorders, major organ system illness, pregnancy, or genetic syndrome
  2. * Medication use known to affect insulin sensitivity, glucose tolerance, or circadian rhythm
  3. * Screening high risk for obstructive sleep apnea
  4. * Night shift work.

Contacts and Locations

Study Contact

Talia Hitt, MD/MPH/MSHP
CONTACT
860-324-0072
thitt2@jhmi.edu

Principal Investigator

Talia Hitt, MD/MPH/MSHP
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Talia Hitt, MD/MPH/MSHP, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-01
Study Completion Date2030-01-31

Study Record Updates

Study Start Date2025-02-01
Study Completion Date2030-01-31

Terms related to this study

Keywords Provided by Researchers

  • chronotype
  • sleep

Additional Relevant MeSH Terms

  • PreDiabetes
  • Overweight
  • Impaired Glucose Tolerance