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Completed

NCT Number: NCT04187521

Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal A

Other

A breakfast meal with a specific macronutrient proportions.

Meal B

Other

A breakfast meal with a specific macronutrient proportions.

Primary outcomes

  1. Peak blood glucose following test meal (CGM)

    Time frame: 15 mins - 3 hours

    Peak postprandial blood glucose after test meal assessed by continuous glucose monitor

Secondary outcomes

  1. One-hour post prandial blood glucose following test meal (SMBG)

    Time frame: 1 hour

    1 hour postprandial blood glucose after test meal on day 2 and day 3 assessed by glucometer

  2. Glucose area under the curve following test meal (CGM)

    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

  3. Meal taste

    Time frame: 1 hour

    Palatability of the test meals measured using a visual analog scale

  4. Meal satiety

    Time frame: 3 hours

    Satiety following meal measured using a visual analog scale

  5. Meal completion

    Time frame: 1 hour

    Percent of test meal finished assessed by photo of completed meal

  6. Peak blood glucose following lunch on day of test meal (CGM)

    Time frame: 15 mins - 3 hours

    Peak postprandial blood glucose after lunch on days of test meals assessed by CGM

  7. One-hour post prandial blood glucose following lunch on day of test meal (SMBG)

    Time frame: 1 hour

    1 hour postprandial blood glucose after lunch on days of test meals assessed by glucometer

  8. Carbohydrate content of lunch after test meal

    Time frame: 6 hours

    Carbohydrate content (grams) of lunch meal following the test meal

  9. Calorie content of lunch after test meal

    Time frame: 6 hours

    Calorie content of lunch meal following the test meal

  10. Peak blood glucose following dinner on day of test meals (CGM)

    Time frame: 15 mins - 3 hours

    Peak postprandial blood glucose after dinner on day of test meal assessed by CGM

  11. One-hour postprandial blood glucose following dinner on day of test meal (SMBG)

    Time frame: 1 hour

    1 hour postprandial blood glucose after dinner on day of test meal assessed by glucometer

  12. Carbohydrate content of dinner after test meal

    Time frame: 6 hours

    Carbohydrate content (grams) of dinner meal following the test meal

  13. Calorie content of dinner after test meal

    Time frame: 6 hours

    Calorie content of dinner meal following the test meal

  14. Mean blood glucose

    Time frame: 24 hours

    Mean blood glucose on the day of the test meal assessed by CGM

  15. Time in target range

    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

  16. Time above target range

    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

  17. Time below target range

    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

  18. Total caloric intake on the days of test meals

    Time frame: 24 hours

    Total calorie intake on the day that the test meal is consumed

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: HINT-GDM

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 5, 2019
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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