Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus

Gestational Diabetes Clinical Trial

— HINT-GDM  

Official title:

Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04187521
• Other study ID #: 2019p002395
• Secondary ID: 74256
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Massachusetts General Hospital
• Contact: Manvi Lohia, MPH
• Phone: 617-643-5638
• Email: hintgdm[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• Meal A
A breakfast meal with a specific macronutrient proportions.
• Meal B
A breakfast meal with a specific macronutrient proportions.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak blood glucose following test meal (CGM)	Peak postprandial blood glucose after test meal assessed by continuous glucose monitor	15 mins - 3 hours
Secondary	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
Secondary	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
Secondary	Meal taste	Palatability of the test meals measured using a visual analog scale	1 hour
Secondary	Meal satiety	Satiety following meal measured using a visual analog scale	3 hours
Secondary	Meal completion	Percent of test meal finished assessed by photo of completed meal	1 hour
Secondary	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
Secondary	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
Secondary	Carbohydrate content of lunch after test meal	Carbohydrate content (grams) of lunch meal following the test meal	6 hours
Secondary	Calorie content of lunch after test meal	Calorie content of lunch meal following the test meal	6 hours
Secondary	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
Secondary	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
Secondary	Carbohydrate content of dinner after test meal	Carbohydrate content (grams) of dinner meal following the test meal	6 hours
Secondary	Calorie content of dinner after test meal	Calorie content of dinner meal following the test meal	6 hours
Secondary	Mean blood glucose	Mean blood glucose on the day of the test meal assessed by CGM	24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	Total caloric intake on the days of test meals	Total calorie intake on the day that the test meal is consumed	24 hours