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

Primary Purpose

Gestational Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meal A
Meal B
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes focused on measuring gestational diabetes, pregnancy, diet, nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General HospitalRecruiting
  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Sensitivity defect

Secretory defect

Unclassified

Arm Description

Participants defined as having abnormal insulin sensitivity without an absolute defect in insulin secretion.

Participants defined as having abnormal insulin secretion without a defect in insulin sensitivity.

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.

Outcomes

Primary Outcome Measures

Peak blood glucose following test meal (CGM)
Peak postprandial blood glucose after test meal assessed by continuous glucose monitor

Secondary Outcome Measures

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

Full Information

First Posted
December 3, 2019
Last Updated
May 7, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04187521
Brief Title
Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus
Acronym
HINT-GDM
Official Title
Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
gestational diabetes, pregnancy, diet, nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sensitivity defect
Arm Type
Other
Arm Description
Participants defined as having abnormal insulin sensitivity without an absolute defect in insulin secretion.
Arm Title
Secretory defect
Arm Type
Other
Arm Description
Participants defined as having abnormal insulin secretion without a defect in insulin sensitivity.
Arm Title
Unclassified
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Meal A
Intervention Description
A breakfast meal with a specific macronutrient proportions.
Intervention Type
Other
Intervention Name(s)
Meal B
Intervention Description
A breakfast meal with a specific macronutrient proportions.
Primary Outcome Measure Information:
Title
Peak blood glucose following test meal (CGM)
Description
Peak postprandial blood glucose after test meal assessed by continuous glucose monitor
Time Frame
15 mins - 3 hours
Secondary Outcome Measure Information:
Title
One-hour post prandial blood glucose following test meal (SMBG)
Description
1 hour postprandial blood glucose after test meal on day 2 and day 3 assessed by glucometer
Time Frame
1 hour
Title
Glucose area under the curve following test meal (CGM)
Description
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
Title
Meal taste
Description
Palatability of the test meals measured using a visual analog scale
Time Frame
1 hour
Title
Meal satiety
Description
Satiety following meal measured using a visual analog scale
Time Frame
3 hours
Title
Meal completion
Description
Percent of test meal finished assessed by photo of completed meal
Time Frame
1 hour
Title
Peak blood glucose following lunch on day of test meal (CGM)
Description
Peak postprandial blood glucose after lunch on days of test meals assessed by CGM
Time Frame
15 mins - 3 hours
Title
One-hour post prandial blood glucose following lunch on day of test meal (SMBG)
Description
1 hour postprandial blood glucose after lunch on days of test meals assessed by glucometer
Time Frame
1 hour
Title
Carbohydrate content of lunch after test meal
Description
Carbohydrate content (grams) of lunch meal following the test meal
Time Frame
6 hours
Title
Calorie content of lunch after test meal
Description
Calorie content of lunch meal following the test meal
Time Frame
6 hours
Title
Peak blood glucose following dinner on day of test meals (CGM)
Description
Peak postprandial blood glucose after dinner on day of test meal assessed by CGM
Time Frame
15 mins - 3 hours
Title
One-hour postprandial blood glucose following dinner on day of test meal (SMBG)
Description
1 hour postprandial blood glucose after dinner on day of test meal assessed by glucometer
Time Frame
1 hour
Title
Carbohydrate content of dinner after test meal
Description
Carbohydrate content (grams) of dinner meal following the test meal
Time Frame
6 hours
Title
Calorie content of dinner after test meal
Description
Calorie content of dinner meal following the test meal
Time Frame
6 hours
Title
Mean blood glucose
Description
Mean blood glucose on the day of the test meal assessed by CGM
Time Frame
24 hours
Title
Time in target range
Description
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
Title
Time above target range
Description
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
Title
Time below target range
Description
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
Title
Total caloric intake on the days of test meals
Description
Total calorie intake on the day that the test meal is consumed
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manvi Lohia, MPH
Phone
617-643-5638
Email
hintgdm@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Emily A Rosenberg, MD
Phone
617-643-5638
Email
earosenberg@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camille E Powe, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27208340
Citation
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.
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Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus

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