Meal A
OtherA breakfast meal with a specific macronutrient proportions.
NCT Number: NCT04187521
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Brigham and Women's Hospital, Boston, Massachusetts, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-Diagnosis of gestational diabetes
Exclusion criteria
A breakfast meal with a specific macronutrient proportions.
A breakfast meal with a specific macronutrient proportions.
Time frame: 15 mins - 3 hours
Peak postprandial blood glucose after test meal assessed by continuous glucose monitor
Time frame: 1 hour
1 hour postprandial blood glucose after test meal on day 2 and day 3 assessed by glucometer
Time frame: 3 hours
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: 1 hour
Palatability of the test meals measured using a visual analog scale
Time frame: 3 hours
Satiety following meal measured using a visual analog scale
Time frame: 1 hour
Percent of test meal finished assessed by photo of completed meal
Time frame: 15 mins - 3 hours
Peak postprandial blood glucose after lunch on days of test meals assessed by CGM
Time frame: 1 hour
1 hour postprandial blood glucose after lunch on days of test meals assessed by glucometer
Time frame: 6 hours
Carbohydrate content (grams) of lunch meal following the test meal
Time frame: 6 hours
Calorie content of lunch meal following the test meal
Time frame: 15 mins - 3 hours
Peak postprandial blood glucose after dinner on day of test meal assessed by CGM
Time frame: 1 hour
1 hour postprandial blood glucose after dinner on day of test meal assessed by glucometer
Time frame: 6 hours
Carbohydrate content (grams) of dinner meal following the test meal
Time frame: 6 hours
Calorie content of dinner meal following the test meal
Time frame: 24 hours
Mean blood glucose on the day of the test meal assessed by CGM
Time frame: 24 hours
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
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
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 calorie intake on the day that the test meal is consumed
Massachusetts General Hospital
Other
Acronym: HINT-GDM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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