UNC-led, multicenter study to examine Metformin’s impact on infant health
October 28, 2016
Four co-investigators from the University of North Carolina at Chapel Hill will lead a five-year, multicenter clinical trial titled Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD). MOMPOD will examine the impact of combined Metformin and insulin therapy on infant outcomes with mothers experiencing Type 2 diabetes in pregnancy.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development awarded $4.2 million over five years to support MOMPOD.
The multidisciplinary project is co-led by four researchers at UNC: Sonia Davis, DrPH, Professor of the Practice of biostatistics at the Gillings School of Global Public Health and director of the Collaborative Studies Coordinating Center, Kim Boggess, MD, professor in the Division of Maternal-Fetal Medicine in the School of Medicine, Diane Berry, PhD, associate professor and Beerstecher-Blackwell Distinguished Term Scholar in the School of Nursing, and Laura Young, MD, PhD, assistant professor in the Division of Endocrinology & Metabolism in the School of Medicine.
Pregnancy naturally results in a mother’s body experiencing an increased resistance to insulin, which allows more glucose to be transferred into energy to fuel fetal development. Unfortunately, more than 100,000 women per year in the United States experience Type 2 diabetes during pregnancy, in which the pancreas is unable to produce enough insulin to manage the amount of glucose that remains in the blood. More than one-third of pregnancies in mothers with Type 2 diabetes have some type of adverse neonatal outcome, such as premature delivery, hypoglycemia (low blood sugar) at birth, infants that are large-for-gestational age or birth trauma.
Insulin therapy has been the standard for treating Type 2 diabetes during pregnancy, but adverse outcomes still exist. Outside of pregnancy, the drug Metformin is favored over insulin by the American Diabetes Association because it results in less weight gain and fewer hypoglycemic episodes. Metformin currently is not recommended for treating Type 2 diabetes in pregnancy, however, due to a lack of large-scale clinical studies.
The MOMPOD Study Consortium will address this gap with an enrollment goal of 1,200 mothers who will be randomized to receive either Metformin or a placebo in addition to insulin.
“Our aim is to test whether the addition of Metformin during pregnancy will decrease the rate of adverse neonatal outcomes,” Davis said.
Results from a previous pilot study of Metformin conducted by Boggess suggested that a combination of Metaformin plus insulin may allow pregnant mothers to better manage their Type 2 diabetes – with fewer episodes of hypoglycemia – than women on insulin alone. These early results encouraged the development of MOMPOD.
“A majority of the maternal-fetal health providers we surveyed believed it should be a treatment continued on through pregnancy, but think it needs the FDA’s blessing,” stated Boggess. “We are eager to help find a better solution than the current insulin-only practice, should MOMPOD’s results prove positive.”
In addition to UNC, nine other institutions will collaborate on the multi-site study:
- Ohio State University
- Columbia University
- University of Alabama at Birmingham
- University of California at San Diego
- University of Mississippi Medical Center
- University of Pennsylvania
- University of Utah
- University of Texas Health Science Center at Houston
- University of Texas Medical Branch at Galveston
Each site was chosen based on geographic and population diversity as well as institutional reputation for upholding research protocol, making the data gathered more generalizable to all women in the U.S. with Type 2 diabetes in pregnancy.
The MOMPOD Study Consortium will begin enrollment in January 2017. All data collected during the study will be managed and analyzed by the UNC Collaborative Studies Coordinating Center (CSCC).
“The CSCC excels in the design, implementation and analysis of multi-center, randomized clinical trials such as MOMPOD,” said Davis. “We are thrilled to be partnering with the UNC School of Medicine on this important study. MOMPOD will benefit from CSCC’s long-time experience conducting multi-center trials, including prior studies of Metformin.”
Participating clinical trial sites will randomize participants and record data in UNC’s state-of-the-art, web-based CDART data management system. CDART (Carolina Data Acquisition and Reporting Tool) was collaboratively developed by the CSCC and the North Carolina Translational and Clinical Sciences Institute for the collection, management and reporting of data for large-scale, multi-site trials.
An additional goal of the consortium is to track long-term outcomes following delivery. For this reason, participants will be invited to join the MOMPOD Dyad Registry, which plans to maintain contact with participating mothers and infants for an additional five-year period.
MOMPOD is an R01 grant that has been eight years in the making and required a large, collaborative effort between multiple institutions and schools at UNC.
It represents the largest trial of Type 2 diabetes in pregnancy ever conducted in the U.S., and the findings potentially will define the optimal therapy for pregnant women with Type 2 diabetes in the future.