The hypothesis for this study is that women with different physiologic subtypes of gestational diabetes (GDM) (insulin secretion deficit vs. insulin sensitivity deficit) will differ in their glycemic responses to meals with different portions of dietary macronutrients. Investigators will determine GDM subtype based on glucose and insulin levels taken at multiple time points during an oral glucose tolerance test. Participants will consume two meals with different macronutrient content while wearing a continuous glucose monitor which will allow investigators to assess the glycemic response to the meals.
Diabetes mellitus can be classified based on impairments in two different physiologic parameters, insulin secretion and insulin sensitivity. The investigator involved in this trial has previously defined GDM subtypes based on underlying physiology and demonstrated that women with GDM and predominant sensitivity defects have an elevated risk of adverse pregnancy outcomes, while women with predominant secretion defects do not appear to carry the same risk. This supports the idea that not all gestational diabetes is the same. Ideal treatment strategies may differ between GDM subtypes. In this trial, investigators will evaluate the postprandial glycemic response to two test meals with different macronutrient content in different GDM physiologic subtypes. Two test meals with different macronutrient proportions have been designed by research dieticians. Participants will eat test meals at home for breakfast in a randomized order after an overnight fast. Participants will complete food and blood sugar diaries, and will wear a continuous glucose monitor, which will measure postprandial glucose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGPeak blood glucose following test meal (CGM)
Peak postprandial blood glucose after test meal assessed by continuous glucose monitor
Time frame: 15 mins - 3 hours
One-hour post prandial blood glucose following test meal (SMBG)
1 hour postprandial blood glucose after test meal on day 2 and day 3 assessed by glucometer
Time frame: 1 hour
Glucose area under the curve following test meal (CGM)
Area under the curve of CGM measured glucose from the start of the test meal to three hours after the test meal is started
Time frame: 3 hours
Meal taste
Palatability of the test meals measured using a visual analog scale
Time frame: 1 hour
Meal satiety
Satiety following meal measured using a visual analog scale
Time frame: 3 hours
Meal completion
Percent of test meal finished assessed by photo of completed meal
Time frame: 1 hour
Peak blood glucose following lunch on day of test meal (CGM)
Peak postprandial blood glucose after lunch on days of test meals assessed by CGM
Time frame: 15 mins - 3 hours
One-hour post prandial blood glucose following lunch on day of test meal (SMBG)
1 hour postprandial blood glucose after lunch on days of test meals assessed by glucometer
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Time frame: 1 hour
Carbohydrate content of lunch after test meal
Carbohydrate content (grams) of lunch meal following the test meal
Time frame: 6 hours
Calorie content of lunch after test meal
Calorie content of lunch meal following the test meal
Time frame: 6 hours
Peak blood glucose following dinner on day of test meals (CGM)
Peak postprandial blood glucose after dinner on day of test meal assessed by CGM
Time frame: 15 mins - 3 hours
One-hour postprandial blood glucose following dinner on day of test meal (SMBG)
1 hour postprandial blood glucose after dinner on day of test meal assessed by glucometer
Time frame: 1 hour
Carbohydrate content of dinner after test meal
Carbohydrate content (grams) of dinner meal following the test meal
Time frame: 6 hours
Calorie content of dinner after test meal
Calorie content of dinner meal following the test meal
Time frame: 6 hours
Mean blood glucose
Mean blood glucose on the day of the test meal assessed by CGM
Time frame: 24 hours
Time in target range
Length of time at which the patient's BG are within goal range (65-140 mg/dl) on the day of test meal assessed by CGM
Time frame: 24 hours
Time above target range
Length of time at which the patient's BG is \>140 mg/dl on the day of test meals assessed by CGM
Time frame: 24 hours
Time below target range
Length of time at which the patient's BG is \<65 mg/dl on the day of test meals assessed by CGM
Time frame: 24 hours
Total caloric intake on the days of test meals
Total calorie intake on the day that the test meal is consumed
Time frame: 24 hours