Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus (MATCh-GDM)

Maisa N. Feghali, MD

Status and phase: Completed; Phase 4

Conditions: Pregnancy in Diabetes; Gestational Diabetes; Diabetes, Gestational

Treatments: Drug: Metformin; Drug: Insulin; Drug: Glyburide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03029702

K23HD092893 (U.S. NIH Grant/Contract)

PRO16100499

Details and patient eligibility

About

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).

Enrollment: 54 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.

Treatment:

Drug: Glyburide

Drug: Metformin

Drug: Insulin

Individualized Treatment

Active Comparator group

Description:

Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.

Treatment:

Drug: Glyburide

Drug: Metformin

Drug: Insulin