Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus (HINT-GDM)

  • STATUS
    Recruiting
  • days left to enroll
    29
  • participants needed
    60
  • sponsor
    Massachusetts General Hospital
Updated on 30 May 2022
diabetes
insulin
tolerance test
oral glucose tolerance test
insulin sensitivity
glucose tolerance test
nutritional support

Summary

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.

Description

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.

Details
Condition Gestational Diabetes
Treatment Meal A, Meal B
Clinical Study IdentifierNCT04187521
SponsorMassachusetts General Hospital
Last Modified on30 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of gestational diabetes

Exclusion Criteria

Known diabetes mellitus that preceded pregnancy
Food allergies to components of the test meals
Use of medications known to affect glucose tolerance
Have extensive skin changes or diseases making CGM sensor use problematic
Demonstrated allergy to CGM adhesive
Inability to adhere to the swimming and bathing instructions
Plan to have MRI, CT scan, X Ray or diathermy (heat treatment) during the 7-day CGM study period
Inability to adhere to Vitamin C guidelines during study period (using more than 500 mg of Vitamin C/day which could interfere with the CGM)
Use of medications known to affect glucose tolerance
In the opinion of the principal investigator (PI), demonstrate any other factor likely to limit compliance with the protocol
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