Phase 4
Completed N=54
Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus
Diabetes · Diabetes, Gestational · Pregnancy in Diabetes
Source: ClinicalTrials.gov NCT03029702 ↗
Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Proportion of Women Who Are Eligible, Screened, Enroll and Remain in the Study — 25; 26 Participants — p=0.9
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Women Who Are Eligible, Screened, Enroll and Remain in the Study |
25; 26 | 0.9 |
| PRIMARY Proportion of Participants Who Report Suitability of the Study Procedures |
24; 25 | 0.8 |
| SECONDARY Proportion of Participants With Consistent GDM Mechanism Before and and After Treatment Initiation |
22; 21 | 0.9 |
| SECONDARY Proportion of Women Who Remain on Same Treatment During Study |
25; 26 | 0.9 |
| SECONDARY Maternal Glucose Control |
20; 22 | 0.8 |
| SECONDARY Proportion of Participants Who Deliver by Primary Cesarean |
9; 11 | 0.6 |
| SECONDARY Proportion of Participants Who Developed Hypertensive Diseases in Pregnancy |
4; 3 | 0.8 |
| SECONDARY Birthweight |
332.5; 3445.4 | 0.7 |
| SECONDARY Neonatal Lean Body Mass |
— | — |
| SECONDARY Cord Blood Glucose |
— | — |
| SECONDARY Cord Blood C-peptide |
— | — |
Eligibility Criteria
Inclusion Criteria
- Pregnant women beyond 24 weeks of gestation who are scheduled for a 3-hour oral glucose tolerance test.
Exclusion Criteria
- Fetal anomaly
- Pregestational diabetes
- GDM diagnosis without a 3-hour OGTT
- Multifetal gestation
- Treatment with non-inhaled steroids within 7 days
- Allergy to glyburide, metformin or sulfa
- History of severe pulmonary (pulmonary requirement for oxygen therapy or daily treatment for restrictive of obstructive pulmonary disease)
- Hepatic (LFT's greater than two times of upper normal range)
- Renal (serum creatinine higher than 1.2 mg/dL) disease
- History of heart failure or myocardial infarction
Data sourced from ClinicalTrials.gov (NCT03029702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.