Clinical trial NCT06507722: Night Owl Metabolism
Official title: Night Owl Metabolism: Investigating the Impact of Chronotype on Glucose Metabolism in Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PreDiabetes
Overweight
Impaired Glucose Tolerance
Keywords: chronotype
sleep
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Lawson Wilkins Pediatric Endocrine Society
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: DexCom, Inc.
First posted: 2024-07-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: For randomization in Aim 1, participants will be assigned to Early or Late OGTT for the first visit with crossover to the alternate for the second visit. In Aim 2, participants will be assigned to Early or Late standardized first meal for Day 1 with crossover to the alternate for Day 8.
Primary purpose: PREVENTION

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 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.

Primary outcomes:
measure: 2-Hour Difference in Glucose
timeFrame: Day 4 and Day 11 of Aim 1 derived from OGTT
measure: Insulin Sensitivity (by Oral Minimal Model)
timeFrame: Day 4 and Day 11 of Aim 1 derived from OGTT
measure: 2-hour Incremental Area Under the Curve (iAUC) for glucose
timeFrame: Day 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal
Secondary outcomes:
measure: Difference in Fasting Glucose
timeFrame: Day 4 and Day 11 of Aim 1 obtained before OGTT
measure: Insulin secretion indices
timeFrame: Day 4 and Day 11 of Aim 1 derived from OGTT
measure: Incremental Area Under the Curve (iAUC) for Insulin
timeFrame: Day 4 and Day 11 of Aim 1 derived from OGTT
measure: Hemoglobin A1c levels
timeFrame: Day 4 of Aim 1 during first OGTT Visit
measure: Difference in Disposition Index
timeFrame: Day 4 and Day 11 of Aim 1 derived from OGTT
measure: Difference in Insulin Clearance
timeFrame: Day 4 and Day 11 of Aim 1 derived from OGTT
measure: Mean Glucose
timeFrame: Up to 8 days
measure: Percent Time Spent Above 120 mg/dL
timeFrame: Up to 8 days
measure: Percent Time Spent Above 140 mg/dL
timeFrame: Up to 8 days
measure: Number of Excursions greater than 140mg/dL
timeFrame: Up to 8 days
measure: Difference in Post-prandial peak
timeFrame: Day 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal
measure: Standard Deviation of Glucose
timeFrame: Up to 8 days
measure: Coefficient of Variation of Glucose
timeFrame: Up to 8 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Talia Hitt, MD/MPH/MSHP
role: PRINCIPAL_INVESTIGATOR
References: