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Diagnostic Test

Meal Timing for Blood Sugar Control

N/A
Waitlist Available
Led By Talia Hitt, MD/MPH/MSHP
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Post-pubertal
Overweight similar to (BMI ≥ 85th percentile but <95th percentile for age and sex per Centers for Disease Control and Prevention growth curves
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 4 and day 11 of aim 1 derived from ogtt
Awards & highlights

Summary

This trial will study how the timing of meals affects blood sugar levels in young adults with different sleep patterns. Participants will have glucose tolerance tests and meals timed to their sleep schedule to see how it affects their

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves standard medical procedures like OGTTs and standardized meals without experimental medications, side effects are minimal but may include discomfort from fasting before tests and potential reactions to consuming glucose for the OGTT.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have gone through puberty.
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I am overweight according to CDC guidelines for my age and sex.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 4 and day 11 of aim 1 derived from ogtt
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 4 and day 11 of aim 1 derived from ogtt for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
2-Hour Difference in Glucose
2-hour Incremental Area Under the Curve (iAUC) for glucose
Insulin Sensitivity (by Oral Minimal Model)
Secondary study objectives
Coefficient of Variation of Glucose
Difference in Disposition Index
Difference in Fasting Glucose
+10 more

Trial Design

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 Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,315 Previous Clinical Trials
14,872,653 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,424 Previous Clinical Trials
4,324,865 Total Patients Enrolled
Lawson Wilkins Pediatric Endocrine SocietyOTHER
3 Previous Clinical Trials
124 Total Patients Enrolled
~47 spots leftby Dec 2029
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