Meal Timing for Blood Sugar Control
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
56789How 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.
610111213Eligibility 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.
+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.
+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
Participant Groups
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.
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 UniversityLead Sponsor
DexCom, Inc.Industry Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
Lawson Wilkins Pediatric Endocrine SocietyCollaborator
References
Timing of meal insulin boluses to achieve optimal postprandial glycemic control in patients with type 1 diabetes. [2022]This study determined the optimal timing of insulin bolus administration in relation to meal consumption in adolescents and adults with type 1 diabetes.
Delayed dinnertime impairs glucose tolerance in healthy young adults. [2023]To explore the relationship between mealtime delays of up to 3 h and subsequent glucose fluctuations, healthy young adults were allocated to three delayed dinnertimes in randomized order. Participants consumed test meals for lunch and dinner. After assessing the glucose responses using intermittently scanned continuous glucose monitoring devices (isCGM), the peak glucose elevation, and incremental area under the curve (iAUC) of postprandial glucose during certain intervals increased significantly when the time between lunch and dinner was delayed by 1 h or more. Our results support the importance of improving irregular mealtime habits, such as late eating.
Omitting late-night eating may cause hypoglycemia in "well controlled" basal insulin-treated type 2 diabetes. [2021]To assess hypoglycemia caused by eating the last meal of the day earlier or its omission in "well controlled" type 2 diabetes mellitus patients treated with once-nightly basal insulin.
Optimal prandial timing of bolus insulin in diabetes management: a review. [2022]The inability to achieve optimal diabetes glucose control in people with diabetes is multifactorial, but one contributor may be inadequate control of postprandial glucose. In patients treated with multiple daily injections of insulin, both the dose and timing of meal-related rapid-acting insulin are key factors in this. There are conflicting opinions and evidence on the optimal time to administer mealtime insulin. We performed a comprehensive literature search to review the published data, focusing on the use of rapid-acting insulin analogues in patients with Type 1 diabetes. Pharmacokinetic and pharmacodynamic studies of rapid-acting insulin analogues, together with postprandial glucose excursion data, suggest that administering these 15-20 min before food would provide optimal postprandial glucose control. Data from clinical studies involving people with Type 1 diabetes receiving structured meals and rapid-acting insulin analogues support this, showing a reduction in post-meal glucose levels of ~30% and less hypoglycaemia when meal insulin was taken 15-20 min before a meal compared with immediately before the meal. Importantly, there was also a greater risk of postprandial hypoglycaemia when patients took rapid-acting analogues after eating compared with before eating.
Efficacy and safety of exenatide administered before the two largest daily meals of Latin American patients with type 2 diabetes. [2022]To evaluate whether exenatide administered before breakfast and dinner (BD) or before lunch and dinner (LD) provided similar glycemic control in Latin American patients with type 2 diabetes mellitus (T2DM) who consume a small breakfast.
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]Delay in peak blood glucose during an oral glucose tolerance test (OGTT) predicts declining β-cell function and poor ability to regulate glucose metabolism. Glucose peak time has not been used as a comparative indicator of the improvement in islet function after treatment with exenatide, insulin, or oral antidiabetic drugs (OADs). We evaluated the efficacy of three types of antidiabetic drugs on the basis of blood glucose peak time in patients with non-newly diagnosed type 2 diabetes.
Assessment of Meal Anticipation for Improving Fully Automated Insulin Delivery in Adults With Type 1 Diabetes. [2023]Meals are a consistent challenge to glycemic control in type 1 diabetes (T1D). Our objective was to assess the glycemic impact of meal anticipation within a fully automated insulin delivery (AID) system among adults with T1D.
Premeal injection of rapid-acting insulin reduces postprandial glycemic excursions in type 1 diabetes. [2022]To assess the effect of three premeal timings of rapid-acting insulin on postprandial glucose excursions in type 1 diabetes.
Timing of Meal Insulin and Its Relation to Adherence to Therapy in Type 1 Diabetes. [2020]The purpose of this study is to examine timing of meal insulin and further determine whether an association exists between timing of meal insulin and missed meal insulin doses. The cohort included 4768 T1D Exchange clinic registry participants
Relationships of Early And Late Glycemic Responses With Gastric Emptying During An Oral Glucose Tolerance Test. [2015]The early glycemic response during a 75-g oral glucose tolerance test (OGTT) is directly related to the rate of gastric emptying (GE). There is little information about the effect of GE on the blood glucose at either 60 min (a predictor of diabetes) or 120 min (used diagnostically).
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]The oral glucose tolerance test (oGTT) is the most common method to estimate indices of insulin sensitivity in clinical as well as in epidemiological studies. The aim of this study was to investigate the variability of insulin levels for reference intervals and of insulin sensitivity indices during oGTT by three different insulin immunoassays.
[Diet and insulin. Best results with an adjusted schedule]. [2015]Hospitalized diabetic patients with vascular disease, showing signs of infection and, perhaps, having had surgery, exhibit profound oscillations in their glucose levels. Better controls need to be followed to account for this variation between meals. To achieve this, the authors modified the meal schedules in a comparative study between two groups of patients that had been admitted to a cardiovascular surgical unit. The variable group consisted of 26 patients (group I) who were given a modified feeding schedule; the sample group that maintained the traditional schedule numbered 20 patients (Group II). All of these individuals have at least a 10 year history of diabetes and averaged 62 years of age. Glucose levels were measured every 6 hours for 20 consecutive days (normal glucose levels were considered 80-250 mg/dl). Results of the experiment were the following. Group I Breakfast 91%, Lunch 72%, Supper 77%, Snack 86%; Group II Breakfast 79%, Lunch 66%, Supper 69%, Bedtime 72%. As these findings indicate, a correct eating schedule for diabetics is a very important aspect in controlling proper blood glucose levels. Part of this work was presented at the VIII National Congress of Vascular Nursing, receiving first prize.
Assessing the shape of the glucose curve during an oral glucose tolerance test. [2022]The oral glucose tolerance test (OGTT) is used to define the status of glucose tolerance based on the plasma glucose level at 120 min. The purpose of the present study was to identify parameters that determine the shape of the plasma glucose course measured at 0, 30, 60, 90, and 120 min during an OGTT.