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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Other: Meal A; Other: Meal B

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sensitivity defect; Participants defined as having abnormal insulin sensitivity without an absolute defect in insulin secretion.	Other: Meal A; A breakfast meal with a specific macronutrient proportions.; Other: Meal B; A breakfast meal with a specific macronutrient proportions.
Other: Secretory defect; Participants defined as having abnormal insulin secretion without a defect in insulin sensitivity.	Other: Meal A; A breakfast meal with a specific macronutrient proportions.; Other: Meal B; A breakfast meal with a specific macronutrient proportions.
Other: Unclassified; Participants who cannot be classified as having abnormal insulin secretion or abnormal insulin sensitivity or who have both abnormal insulin sensitivity and abnormal insulin secretion.	Other: Meal A; A breakfast meal with a specific macronutrient proportions.; Other: Meal B; A breakfast meal with a specific macronutrient proportions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak blood glucose following test meal (CGM)	Peak postprandial blood glucose after test meal assessed by continuous glucose monitor	15 mins - 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	3 hours
Meal taste	Palatability of the test meals measured using a visual analog scale	1 hour
Meal satiety	Satiety following meal measured using a visual analog scale	3 hours
Meal completion	Percent of test meal finished assessed by photo of completed meal	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	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	1 hour
Carbohydrate content of lunch after test meal	Carbohydrate content (grams) of lunch meal following the test meal	6 hours
Calorie content of lunch after test meal	Calorie content of lunch meal following the test meal	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	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	1 hour
Carbohydrate content of dinner after test meal	Carbohydrate content (grams) of dinner meal following the test meal	6 hours
Calorie content of dinner after test meal	Calorie content of dinner meal following the test meal	6 hours
Mean blood glucose	Mean blood glucose on the day of the test meal assessed by CGM	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	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	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	24 hours
Total caloric intake on the days of test meals	Total calorie intake on the day that the test meal is consumed	24 hours

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Camille E Powe, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Powe CE, Allard C, Battista MC, Doyon M, Bouchard L, Ecker JL, Perron P, Florez JC, Thadhani R, Hivert MF. Heterogeneous Contribution of Insulin Sensitivity and Secretion Defects to Gestational Diabetes Mellitus. Diabetes Care. 2016 Jun;39(6):1052-5. doi: 10.2337/dc15-2672. Epub 2016 May 13.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: nutrition; pregnancy; diet; gestational diabetes
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes, Gestational
• Other Study ID Numbers: 2019p002395; 74256 (Other Grant/Funding Number: Robert Wood Johnson Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No