No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 23
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
70 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for young people aged 18 to 23 who are overweight and have prediabetes. Participants will provide information about their sleep patterns and take part in tests to see how their bodies respond to glucose after meals at different times.
Are You a Good Fit for This Trial?
You may be able to join if
I am overweight but not extremely so.
I have gone through puberty.
I sleep more than 7 hours each night.
My sleep schedule on weekends and weekdays is not very different.
You may not be able to join if
I have diabetes.
I have sleep disorders.
I have a serious illness.
I am pregnant.
I use medication that affects insulin or glucose levels.
I am at high risk for sleep apnea.
I work night shifts.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 sensi…
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.
Trial Locations
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State
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Status
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 perce…
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.
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