Night Owl Metabolism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Timing of OGTT, Timing of Standardized Meal.
- Who it may be relevant to
- Registry conditions: PreDiabetes, Overweight, Impaired Glucose Tolerance. Basic parameters: 18 years — 23 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Night Owl Metabolism: Investigating the Impact of Chronotype on Glucose Metabolism in Youth
Overview
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.
Interventions
- Diagnostic test Timing of OGTT
In Aim 1, timing of oral glucose tolerance test will be altered. - Behavioral Timing of Standardized Meal
In Aim 2, timing of a standardized meal will be altered.
Primary outcome measures
- 2-Hour Difference in Glucose [Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT]
- Insulin Sensitivity (by Oral Minimal Model) [Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT]
- 2-hour Incremental Area Under the Curve (iAUC) for glucose [Time frame: Day 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal]
Secondary outcome measures (12)
- Difference in Fasting Glucose [Time frame: Day 4 and Day 11 of Aim 1 obtained before OGTT]
- Insulin secretion indices [Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT]
- Incremental Area Under the Curve (iAUC) for Insulin [Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT]
- Hemoglobin A1c levels [Time frame: Day 4 of Aim 1 during first OGTT Visit]
- Difference in Disposition Index [Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT]
- Difference in Insulin Clearance [Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT]
- Mean Glucose [Time frame: Up to 8 days]
- Percent Time Spent Above 120 mg/dL [Time frame: Up to 8 days]
- Percent Time Spent Above 140 mg/dL [Time frame: Up to 8 days]
- Number of Excursions greater than 140mg/dL [Time frame: Up to 8 days]
- Difference in Post-prandial peak [Time frame: Day 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal]
- Standard Deviation of Glucose [Time frame: Up to 8 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Johns Hopkins School of Medicine — Baltimore
Identifiers
NCT: NCT06507722 · IRB00428863