This trial is !
Search for a recruiting clinical trial for your condition
You can access this
clinical trial
if you have
Gestational Diabetes, Diabetes, Gestational or Pregnancy in Diabetes
and you are
between 18 and 45
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
Show me locations

The purpose

Gestational diabetes (GDM) is a significant clinical and public health burden, affecting over 400,000 pregnant women in the United States each year. Without adequate treatment, women with GDM and their infants are at risk for substantial morbidity. Because of this, experts recommend treatment focused on normalization of hyperglycemia to improve outcomes. However, providers have limited capacity to predict which treatment will achieve glycemic goals. This results in a choice based on provider and patient preference and a trial and error approach, which can create delays in glycemic control within the short (8-10 weeks) window between diagnosis and delivery. Maternal and fetal morbidity may be related to a mismatch between glycemic pathophysiology and the mechanism of action of glucose-lowering agents. In fact, GDM is heterogeneous, with predominant insulin resistance (IR) in 50%, insulin secretion deficit (ISD) in 30%, and a combination of both in 20% of women as underlying mechanisms of hyperglycemia. This variation in GDM pathophysiology and clinical outcomes supports the use of an individualized treatment approach. The overall goal of this project is to investigate an individualized treatment approach for GDM where treatment is based on each woman's GDM mechanism. The study will employ the same treatment in both arms, but choice of treatment will differ based on study arm (matched or unmatched to GDM mechanism).

Provided treatments

  • Drug: Insulin
  • Drug: Glyburide
  • Drug: Metformin
Wondering what is the locations section for?
We will connect you to the doctor responsible for this trial and help you get more information.

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT03029702. The sponsor of the trial is Maisa Feghali and it is looking for 60 volunteers for the current phase.
Official trial title:
Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus