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

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).

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes; Diabetes, Gestational; Pregnancy in Diabetes
• Intervention / Treatment: Drug: Insulin; Drug: Glyburide; Drug: Metformin

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Maisa N Feghali, MD; Phone Number: 4126414874; Email: feghalim@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Womens Hospital of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.	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
Active Comparator: Individualized Treatment; Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of women who are eligible, screened, enroll and remain in the study		Through study completion, an average of 16 weeks
Proportion of participants who report suitability of the study procedures	Suitability of the study procedures and interventions to participants assessed through one-on-one qualitative interview	Through study completion, an average of 16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Maisa N. Feghali, MD
• Investigators: Principal Investigator: Maisa N Feghali, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2018
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (Estimated): January 24, 2017

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Insulin resistance; Gestational diabetes; Diabetes in pregnancy; Insulin secretion deficiency
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin; Glyburide
• Other Study ID Numbers: PRO16100499

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No