Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus

Gestational Diabetes Clinical Trial

— MATCh-GDM  

Official title:

Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029702
• Other study ID #: PRO16100499
• Status: Completed
• Phase: Phase 4
• Start date: February 28, 2018
• Est. completion date: August 31, 2023

Study information

• Verified date: December 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy in Diabetes
• Pregnancy in Diabetics

Intervention

Drug:
• Insulin
Insulin will be used for GDM treatment
• Glyburide
Glyburide will be used for GDM treatment
• Metformin
Metformin will be used for GDM treatment

Locations

Country	Name	City	State
United States	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Maisa N. Feghali, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women who are eligible, screened, enroll and remain in the study		Through study completion, an average of 16 weeks
Primary	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	Proportion of participants with consistent GDM mechanism before and and after treatment initiation		2 weeks after treatment initiation
Secondary	Proportion of women who remain on same treatment during study		Through study completion, an average of 16 weeks
Secondary	Maternal glucose control		Delivery
Secondary	Proportion of participants who deliver by primary cesarean		Delivery
Secondary	Proportion of participants who developed hypertensive diseases in pregnancy		Delivery
Secondary	Birthweight		Delivery
Secondary	Neonatal lean body mass		Within 72 hours of delivery
Secondary	Cord blood glucose		Delivery
Secondary	Cord blood c-peptide		Delivery