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Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus

NCT04187521 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Gestational Diabetes

Interventions

OTHER

Meal A

A breakfast meal with a specific macronutrient proportions.

OTHER

Meal B

A breakfast meal with a specific macronutrient proportions.

Sponsors & Collaborators

Principal Investigators

  • Camille E Powe, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04187521 on ClinicalTrials.gov