Clinical trial NCT04187521: Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus
Official title: Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Keywords: gestational diabetes
pregnancy
diet
nutrition
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Peak blood glucose following test meal (CGM)
timeFrame: 15 mins - 3 hours
Secondary outcomes:
measure: One-hour post prandial blood glucose following test meal (SMBG)
timeFrame: 1 hour
measure: Glucose area under the curve following test meal (CGM)
timeFrame: 3 hours
measure: Meal taste
timeFrame: 1 hour
measure: Meal satiety
timeFrame: 3 hours
measure: Meal completion
timeFrame: 1 hour
measure: Peak blood glucose following lunch on day of test meal (CGM)
timeFrame: 15 mins - 3 hours
measure: One-hour post prandial blood glucose following lunch on day of test meal (SMBG)
timeFrame: 1 hour
measure: Carbohydrate content of lunch after test meal
timeFrame: 6 hours
measure: Calorie content of lunch after test meal
timeFrame: 6 hours
measure: Peak blood glucose following dinner on day of test meals (CGM)
timeFrame: 15 mins - 3 hours
measure: One-hour postprandial blood glucose following dinner on day of test meal (SMBG)
timeFrame: 1 hour
measure: Carbohydrate content of dinner after test meal
timeFrame: 6 hours
measure: Calorie content of dinner after test meal
timeFrame: 6 hours
measure: Mean blood glucose
timeFrame: 24 hours
measure: Time in target range
timeFrame: 24 hours
measure: Time above target range
timeFrame: 24 hours
measure: Time below target range
timeFrame: 24 hours
measure: Total caloric intake on the days of test meals
timeFrame: 24 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Camille E Powe, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.