Research Database
Effectiveness study of a lifestyle intervention versus metformin in mothers with recent gestational diabetes
Wanda K., MD
Institution:
The George Washington University
Grant Number:
11-22-ICTSN-15
Project Date:
-
Project Status:
active

Research Description

Of the 4 million women who give birth each year in the United States, about 7-14% (at least 240,000) will a diagnosis of gestational diabetes mellitus (also known as GDM), depending on race/ethnicity, geography and diagnostic thresholds. Mothers with GDM are at high risk for type 2 diabetes and cardiovascular disease (CVD). Weight loss after delivery is critical to reducing chronic obesity and the downstream consequences of diabetes and CVD. Lifestyle counseling with behavioral modification is considered first-line postpartum treatment in women with recent GDM. However, mothers often find it difficult to maintain healthy behaviors over time given the multiple demands of newborn care, family and work commitments, and the relatively short-time frame between pregnancies as they are growing their families. Metformin may be a reasonable alternative given the weight reduction shown in DPP, but to date, there is no comparative data in women with recent GDM. The postpartum period, (12 to 24 months after delivery), represents an important transition in a woman’s lifespan In collaboration with our advocacy partner, DiabetesSisters, we propose a 12-month clinical trial to compare a DPP-based lifestyle intervention is delivered by trained practice staff (nutritionists, health educators, or nurses) through in-person group sessions supported with web lessons and guided feedback on self-monitoring measures using the electronic health record or email, to daily metformin . Women enrolled across two health systems, comprised of community-based sites, will be randomized in a 1:1 ratio to the lifestyle intervention or metformin plus standard lifestyle advice.

Research Profile

What area of diabetes research does your project cover? What role will this particular project play in preventing, treating and/or curing diabetes?

My diabetes portfolio focuses on screening and management of gestational diabetes mellitus (also known as diabetes in pregnancy). My prior studies have investigated screening strategies for gestational diabetes and behavioral interventions to manage glucose levels during pregnancy. Pregnant persons with a history of diabetes are at risk for developing type 2 diabetes in the years following pregnancy. In this currently funded proposal, I focus on interventions in the postpartum period to reduce the risk of converting to type 2 diabetes. The goal is to enroll patients into a study in which they are randomized into one of two groups: 1) metformin or 2) a lifestyle intervention adapted from the Diabetes Prevention Program. The primary outcomes are weight loss, normal glucose levels and quality of life.

If a person with diabetes were to ask you how your project will help them in the future, how would you respond?

The goal of my research is to improve the health of mothers with recent gestational diabetes. With funding from the ADA, we will be able to conduct a clinical trial to compare weight loss and glucose control during the first year after delivery. Prior studies have shown that postpartum weight loss (losing the pounds gained during pregnancy or achieving a healthy weight) can greatly reduce the chances that a mother with recent gestational diabetes will develop type 2 diabetes. Our research will compare postpartum weight loss and glucose control in mothers who complete a diet and physical activity intervention and those who complete pharmacologic therapy with metformin. Ultimately, our goal is to reduce the numbers of mothers who progress to type 2 diabetes. This will help mothers to have healthier future pregnancies and improve her long-term health.

Why important for you, personally, to become involved in diabetes research? What role will this award play?

I have committed my research to developing interventions to prevent chronic disease in young women. As a practicing obstetrician, I recognize that pregnancy can be ‘a window on the future’ of women’s health. I will continue to devote my research to investigating interventions that can improve the clinical care of women with recent gestational diabetes and help mothers and their infants live healthier lives. I am committed to Healthy Moms and Healthy Babies.

In what direction do you see the future of diabetes research going?

As the heightened focus on postpartum care continues, I anticipate that more research will emerge that investigates interventions for moms and babies in the year after delivery. The U.S. is in the process of providing clinical coverage up to 1 year after delivery. I believe this will open a window of opportunity for continued research for mothers during this important period in their lives.