Abstract
BackgroundGestational diabetes mellitus (GDM), a hyperglycemic state detected during pregnancy, is an established risk factor for diabetes. However, treatment during pregnancy in and of itself is not able to eliminate this risk, and a considerable fraction of women with GDM will develop frank diabetes in the decade following pregnancy. Our aim is to conduct a multicenter randomized controlled trial to investigate the effectiveness of a lifestyle intervention program implemented after a pregnancy complicated by GDM in delaying or preventing the development of type 2 diabetes.MethodsWomen aged 18 or older identified as having recent GDM are recruited and followed by telephone to assess eligibility for the trial. To be eligible, women must have used insulin during pregnancy or present intermediate hyperglycemia postpartum. Women are encouraged to enter the trial as early as 10 weeks, and are permitted to do so up to 2 years after a pregnancy with GDM. An estimated 740 women will be randomized to either conventional care or to coach-based interventions focused on breastfeeding, weight loss, healthy eating, and increased physical activity, and predominantly delivered by telephone. Women are followed annually to detect new onset diabetes, the primary outcome, and additional secondary outcomes which include reversion to normoglycemia, weight loss, physical activity and fitness, and insulin resistance.DiscussionThough previous studies have demonstrated that type 2 diabetes can be delayed or prevented, no study has yet demonstrated the feasibility and effectiveness of similar interventions implemented in the postpartum period for women with recent GDM. If shown to be successful, this approach could become an important means of preventing diabetes in primary care settings.Trial registrationClinicalTrials.gov Identifier: NCT02327286; Registered 23 December 2014.
Highlights
Gestational diabetes mellitus (GDM), a hyperglycemic state detected during pregnancy, is an established risk factor for diabetes
As shown by two landmark clinical trials, the Diabetes Prevention Program (DPP) and the Diabetes Prevention Study (DPS): an average of three years of lifestyle interventions can reduce by 58 % the incidence of type 2 diabetes in individuals presenting impaired glucose tolerance [2, 3]
A clinical trial showed that troglitazone could reduce diabetes incidence by 55 % when applied to very high risk women with GDM, the drug was subsequently withdrawn from the market due to serious adverse effects [8]
Summary
Gestational diabetes mellitus (GDM), a hyperglycemic state detected during pregnancy, is an established risk factor for diabetes. More recent randomized trials are testing the effect of lifestyle interventions after pregnancy among women with GDM with the aim of preventing diabetes. One such trial randomized 450 women with GDM and impaired glucose tolerance postpartum in China and found that the incidence of diabetes did not differ between the intervention (15 %) and the control group (19 %), after 36 months of follow up [9]. An additional randomized trial is testing the efficacy of an individuallytailored lifestyle intervention to reduce risk factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance during pregnancy [13]
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