| NCT ID | NCT06507722 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | PreDiabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-02-25 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Talia Hitt, MD/MPH/MSHP
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06507722 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 23 Years, studying PreDiabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06507722 currently recruiting?
Yes, NCT06507722 is actively recruiting participants. Contact the research team at thitt2@jhmi.edu for enrollment information.
Where is the NCT06507722 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06507722 clinical trial?
NCT06507722 is sponsored by Johns Hopkins University. The principal investigator is Talia Hitt, MD/MPH/MSHP at Johns Hopkins University. The trial plans to enroll 70 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.