Health TrialsbyHealthPanel

Night Owl Metabolism

ConditionsPreDiabetesOverweightImpaired Glucose Tolerance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-23
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Timing of OGTT

    Diagnostic test

    In Aim 1, timing of oral glucose tolerance test will be altered.

  • Timing of Standardized Meal

    Behavioral

    In Aim 2, timing of a standardized meal will be altered.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Cohort A - Late Chronotype first, then alternateOther 2 interventions
Group B: Cohort B - Non-late Chronotype first, then alternateOther 2 interventions

Trial outcomes

Primary outcomes

1

2-Hour Difference in Glucose

Within-subject difference in 2-hour glucose after glucose ingestion on OGTT between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.

Time frame
Day 4 and Day 11 of Aim 1 derived from OGTT
2

Insulin Sensitivity (by Oral Minimal Model)

Within-subject difference in insulin sensitivity (derived from oral Minimal Model) between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.

Time frame
Day 4 and Day 11 of Aim 1 derived from OGTT
3

2-hour Incremental Area Under the Curve (iAUC) for glucose

Within-subject difference in iAUC for glucose from continuous glucose monitor between early and late Meal (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late Meal.

Time frame
Day 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal

Secondary outcomes

1

Difference in Fasting Glucose

Within-subject difference in fasting glucose at start of OGTT between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.

Time frame
Day 4 and Day 11 of Aim 1 obtained before OGTT
2

Insulin secretion indices

Within-subject difference in insulin secretion (dynamic phase, static phase, total and insulin secretory rate) from c-peptide minimal model between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.

Time frame
Day 4 and Day 11 of Aim 1 derived from OGTT
3

Incremental Area Under the Curve (iAUC) for Insulin

Within-subject difference in iAUC for insulin after glucose ingestion between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.

Time frame
Day 4 and Day 11 of Aim 1 derived from OGTT
4

Hemoglobin A1c levels

Analysis of between group differences in hemoglobin A1c levels

Time frame
Day 4 of Aim 1 during first OGTT Visit

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

Lawson Wilkins Pediatric Endocrine Society

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

DexCom, Inc.

Collaborator

Source ClinicalTrials.gov
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