Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for young individuals aged 17-23 with obesity, prediabetes, or diabetes. It's specifically designed to see how their body clock (chronotype) affects their blood sugar control when they take a glucose test or have their first meal of the day at different times.Inclusion Criteria
I have gone through puberty.
I am overweight according to CDC guidelines for my age and sex.
Treatment Details
The study is testing if timing an oral glucose tolerance test (OGTT) or the first meal of the day according to a person's natural sleep/wake cycle can affect insulin sensitivity and blood sugar levels in youth. Participants will experience tests both aligned and misaligned with their chronotype.
2Treatment groups
Experimental Treatment
Group I: Cohort B - Non-late Chronotype first, then alternateExperimental Treatment2 Interventions
Sleep onset before 11pm
Group II: Cohort A - Late Chronotype first, then alternateExperimental Treatment2 Interventions
Sleep onset after 2am
Find a clinic near you
Research locations nearbySelect from list below to view details:
Johns Hopkins School of MedicineBaltimore, MD
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
DexCom, Inc.Industry Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
Lawson Wilkins Pediatric Endocrine SocietyCollaborator