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NCT03029702 · ClinicalTrials.gov registry record · Phase 4
Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus
A Phase 4 study, sponsored by Maisa N. Feghali, MD.
- Completed
- Registry status
- Phase 4
- Development phase
- 54
- Enrollment target
NCT03029702 is a Phase 4 study that has completed, run by Maisa N. Feghali, MD. The registered enrollment target is 54 participants.
The verdict
NCT03029702, a Phase 4 study, has completed, sponsored by Maisa N. Feghali, MD.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 54 participants
- Enrollment target
Study 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).
Interventions
- DRUG Metformin
- DRUG Insulin
- DRUG Glyburide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2018-02-28 |
| Est. Completion | 2023-08-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03029702
The ClinicalTrials.gov registry entry for NCT03029702 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Maisa N. Feghali, MD, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Metformin is the first listed.
NCT03029702 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03029702 about?
NCT03029702 is a clinical study titled "Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus". 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 focuse...
What is the current status of trial NCT03029702?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 54 participants. The study started on 2018-02-28. Estimated completion is 2023-08-31.
What interventions are being tested in trial NCT03029702?
The interventions under investigation include: Metformin (DRUG), Insulin (DRUG), Glyburide (DRUG).
Who is sponsoring clinical trial NCT03029702?
This trial is sponsored by Maisa N. Feghali, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
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