~47 spots leftby Dec 2029

Meal Timing for Blood Sugar Control

Recruiting in Palo Alto (17 mi)
TH
Overseen byTalia Hitt, MD/MPH/MSHP
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Must not be taking: Insulin, Melatonin, others
Disqualifiers: Diabetes, Sleep disorders, Pregnancy, others
No Placebo Group

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?

The research articles provided do not contain specific safety data related to meal timing for blood sugar control in humans.56789

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

TH

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

Normal sleep duration (average >7 hours of sleep per night)
Social jetlag (difference between weekend and weekday sleep) of < 2 hours
I have gone through puberty.
See 1 more

Exclusion Criteria

Screening high risk for obstructive sleep apnea
I am not on medications that affect insulin sensitivity, glucose tolerance, or my body clock.
I have diabetes, a sleep disorder, a major illness, am pregnant, or have a genetic syndrome.
See 1 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomized Cross-over

Participants undergo 2 OGTTs (aligned and mis-aligned with chronotype) to compare glucose tolerance and insulin sensitivity

11 days
Multiple visits for OGTTs on Day 4 and Day 11

Standardized Meal Testing

Participants undergo two standardized meals (aligned and mis-aligned with chronotype) while wearing continuous glucose monitoring

8 days
Continuous monitoring over 8 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Timing of OGTT (Diagnostic Test)
  • Timing of Standardized Meal (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Research Locations NearbySelect from list below to view details:
Johns Hopkins School of MedicineBaltimore, MD
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Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2366
Patients Recruited
15,160,000+

DexCom, Inc.

Industry Sponsor

Trials
151
Patients Recruited
35,700+

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

Collaborator

Trials
2513
Patients Recruited
4,366,000+

Lawson Wilkins Pediatric Endocrine Society

Collaborator

Trials
4
Patients Recruited
190+

Findings from Research

Timing of meal insulin boluses to achieve optimal postprandial glycemic control in patients with type 1 diabetes.Cobry, E., McFann, K., Messer, L., et al.[2022]
Delayed dinnertime impairs glucose tolerance in healthy young adults.Nakamura, F., Shimba, Y., Toyonaga, S., et al.[2023]
Omitting late-night eating may cause hypoglycemia in "well controlled" basal insulin-treated type 2 diabetes.King, AB., Clark, D.[2021]
Optimal prandial timing of bolus insulin in diabetes management: a review.Slattery, D., Amiel, SA., Choudhary, P.[2022]
In a study of 377 Latin American patients with type 2 diabetes, exenatide taken before breakfast or lunch showed similar effectiveness in lowering HbA1c levels, with both regimens achieving significant reductions of approximately 1.2% and 1.1%, respectively.
The safety profile was comparable for both dosing schedules, with similar rates of hypoglycemia and nausea, indicating that either timing of exenatide administration is a safe option for improving glycemic control in patients who consume a small breakfast.
Efficacy and safety of exenatide administered before the two largest daily meals of Latin American patients with type 2 diabetes.Forti, A., Garcia, EG., Yu, MB., et al.[2022]
Shift of Glucose Peak Time During Oral Glucose Tolerance Test is Associated with Changes in Insulin Secretion and Insulin Sensitivity After Therapy with Antidiabetic Drugs in Patients with Type 2 Diabetes.Jiang, Y., Cui, S., Zhang, R., et al.[2021]
Assessment of Meal Anticipation for Improving Fully Automated Insulin Delivery in Adults With Type 1 Diabetes.Garcia-Tirado, J., Colmegna, P., Villard, O., et al.[2023]
Premeal injection of rapid-acting insulin reduces postprandial glycemic excursions in type 1 diabetes.Luijf, YM., van Bon, AC., Hoekstra, JB., et al.[2022]
Timing of Meal Insulin and Its Relation to Adherence to Therapy in Type 1 Diabetes.Datye, KA., Boyle, CT., Simmons, J., et al.[2020]
Relationships of Early And Late Glycemic Responses With Gastric Emptying During An Oral Glucose Tolerance Test.Marathe, CS., Horowitz, M., Trahair, LG., et al.[2015]
Assay-dependent variability of serum insulin levels during oral glucose tolerance test: influence on reference intervals for insulin and on cut-off values for insulin sensitivity indices.Werner, M., Tönjes, A., Stumvoll, M., et al.[2016]
[Diet and insulin. Best results with an adjusted schedule].Martínez Martínez, A., Bonaventura Sans, C., Malet Bonet, M.[2015]
Assessing the shape of the glucose curve during an oral glucose tolerance test.Tschritter, O., Fritsche, A., Shirkavand, F., et al.[2022]

References

Timing of meal insulin boluses to achieve optimal postprandial glycemic control in patients with type 1 diabetes. [2022]
Delayed dinnertime impairs glucose tolerance in healthy young adults. [2023]
Omitting late-night eating may cause hypoglycemia in "well controlled" basal insulin-treated type 2 diabetes. [2021]
Optimal prandial timing of bolus insulin in diabetes management: a review. [2022]
Efficacy and safety of exenatide administered before the two largest daily meals of Latin American patients with type 2 diabetes. [2022]
Shift of Glucose Peak Time During Oral Glucose Tolerance Test is Associated with Changes in Insulin Secretion and Insulin Sensitivity After Therapy with Antidiabetic Drugs in Patients with Type 2 Diabetes. [2021]
Assessment of Meal Anticipation for Improving Fully Automated Insulin Delivery in Adults With Type 1 Diabetes. [2023]
Premeal injection of rapid-acting insulin reduces postprandial glycemic excursions in type 1 diabetes. [2022]
Timing of Meal Insulin and Its Relation to Adherence to Therapy in Type 1 Diabetes. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Relationships of Early And Late Glycemic Responses With Gastric Emptying During An Oral Glucose Tolerance Test. [2015]
Assay-dependent variability of serum insulin levels during oral glucose tolerance test: influence on reference intervals for insulin and on cut-off values for insulin sensitivity indices. [2016]
[Diet and insulin. Best results with an adjusted schedule]. [2015]
13.United Statespubmed.ncbi.nlm.nih.gov
Assessing the shape of the glucose curve during an oral glucose tolerance test. [2022]