Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus

Phase 4

Completed

Conditions: Gestational Diabetes
Diabetes, Gestational
Pregnancy in Diabetes

Brief 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Individualized Treatment	Insulin	Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
Usual Care	Insulin	Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Individualized Treatment	Metformin	Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
Usual Care	Glyburide	Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Usual Care	Metformin	Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Individualized Treatment	Glyburide	Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.

Primary Outcome Measures

Name	Time	Method
Proportion of Women Who Are Eligible, Screened, Enroll and Remain in the Study	Through study completion, an average of 16 weeks	Proportion of women who are eligible, screened, enrolled and remain in the study
Proportion of Participants Who Report Suitability of the Study Procedures	Through study completion, an average of 16 weeks	Suitability of the study procedures and interventions to participants assessed through one-on-one qualitative interview

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants With Consistent GDM Mechanism Before and and After Treatment Initiation	2 weeks after treatment initiation
Proportion of Women Who Remain on Same Treatment During Study	Through study completion, an average of 16 weeks
Maternal Glucose Control	Delivery	\>50% fasting below 95 and 1 hour postprandial \< 140 during the 4 weeks before delivery
Proportion of Participants Who Deliver by Primary Cesarean	Delivery
Proportion of Participants Who Developed Hypertensive Diseases in Pregnancy	Delivery
Birthweight	Delivery
Neonatal Lean Body Mass	Within 72 hours of delivery
Cord Blood Glucose	Delivery
Cord Blood C-peptide	Delivery