Trials / Completed
CompletedNCT03029702
Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Maisa N. Feghali, MD · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Insulin | Insulin will be used for GDM treatment |
| DRUG | Glyburide | Glyburide will be used for GDM treatment |
| DRUG | Metformin | Metformin will be used for GDM treatment |
Timeline
- Start date
- 2018-02-28
- Primary completion
- 2023-08-31
- Completion
- 2023-08-31
- First posted
- 2017-01-24
- Last updated
- 2024-11-29
- Results posted
- 2024-11-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03029702. Inclusion in this directory is not an endorsement.