Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus
Completed · Not applicable
Conditions studied: Gestational Diabetes
In brief
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.
Key facts
- Study ID
- NCT04187521
- Run by
- Massachusetts General Hospital
- People needed
- 19
- Starts
- 2020-02-10
- Expected to finish
- 2022-11-30
- Last updated by the study team
- 2026-05-15
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of gestational diabetes
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.