Meal Timing for Blood Sugar Control
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
If you are taking medications that affect insulin sensitivity, glucose tolerance, or circadian rhythm, you may need to stop them to participate in this trial.
What data supports the effectiveness of the treatment Timing of OGTT, Timing of Standardized Meal for blood sugar control?
Research shows that the timing of meals and insulin can significantly impact blood sugar levels. For example, taking insulin 15-20 minutes before eating can reduce post-meal blood sugar spikes by about 30% in people with diabetes. Additionally, delaying meals can lead to higher blood sugar levels, highlighting the importance of regular meal timing.12345
Is meal timing for blood sugar control safe for humans?
How does the treatment of meal timing for blood sugar control differ from other treatments for diabetes?
This treatment focuses on the timing of meals and glucose tests to manage blood sugar levels, which is different from traditional diabetes treatments that primarily use medications like insulin or oral drugs. By adjusting when meals and glucose tests occur, it aims to improve blood sugar control through natural body processes rather than relying solely on medication.610111213
Research Team
Talia Hitt, MD/MPH/MSHP
Principal Investigator
Johns Hopkins University
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Randomized Cross-over
Participants undergo 2 OGTTs (aligned and mis-aligned with chronotype) to compare glucose tolerance and insulin sensitivity
Standardized Meal Testing
Participants undergo two standardized meals (aligned and mis-aligned with chronotype) while wearing continuous glucose monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Timing of OGTT (Diagnostic Test)
- Timing of Standardized Meal (Behavioral Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
DexCom, Inc.
Industry Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Lawson Wilkins Pediatric Endocrine Society
Collaborator