Status:
RECRUITING
Night Owl Metabolism
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Lawson Wilkins Pediatric Endocrine Society
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
PreDiabetes
Overweight
Eligibility:
All Genders
18-23 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2030
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06507722
Start Date
February 25 2025
End Date
January 31 2030
Last Update
June 4 2025
Active Locations (1)
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1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287