ESPEYB20 10. Type 2 Diabetes, Metabolic Syndrome and Lipid Metabolism New Drugs for Children with T2DM (5 abstracts)
10.8. Outcomes in children of women with type 2 diabetes exposed to metformin versus placebo during pregnancy (MiTy Kids): a 24-month follow-up of the MiTy randomised controlled trial
Feig DS , Sanchez JJ , Murphy KE , Asztalos E , Zinman B , Simmons D , Haqq AM , Fantus IG , Lipscombe L , Armson A , Barrett J , Donovan L , Karanicolas P , Tobin S , Mangoff K , Klein G , Jiang Y , Tomlinson G , Hamilton J & Hamilton MiTy Kids Collaborative Group
Lancet Diabetes Endocrinol. 2023 Mar;11(3):191–202. doi: 10.1016/S2213-8587(23)00004-9
Brief summary: MiTy Kids is a prospective cohort study of children who were exposed to metformin during pregnancy. At 24 months, no difference was observed between those exposed to metformin and a placebo group, in BMI trajectories, mean BMI Z-score, or mean sum of skinfolds. Among those exposed to metformin, the BMI was higher among males than females.
Comment: Metformin is increasingly used during pregnancy in women with T2D, but data on its long-term effects on the children of these women are limited. The MiTy (Metformin in Women with T2D in Pregnancy Trial)1 is a multicenter, randomized control trial of women with T2DM in pregnancy (sample size n=500). It assessed the effect of the addition of metformin to a standard regimen of insulin, on perinatal morbidity and mortality. Metformin-treated women compared to a placebo group achieved better glycemic control, required less insulin, gained less weight and had fewer caesarean births. Indeed, among newborns of metformin-exposed women with T2D, gestational age at birth and adiposity measures were greatly reduced. However, a higher proportion of infants in the metformin group were small for gestational age (13% vs. 7%).
As a follow-up to the MiTy trial, MiTy Kids assessed whether metformin treatment of pregnant women with T2D might reduce adiposity and improve insulin resistance in their offspring. At 24 months, the mean weight of all children of women with T2D was about 1 standard deviation heavier than the World Health Organisation reference. The groups did not differ in BMI trajectories, mean BMI Z-score, or the mean sum of skinfolds.
Interestingly, in males, BMI trajectories differed significantly by treatment. Specifically, mean BMI was higher for males in the metformin group than in placebo group from 6 months to 24 months, however mean BMI for both sexes combined were similar to those of the placebo group. The authors hypothesize that males are more insulin sensitive, which renders them more sensitive to maternal hyperglycemia, and in turn might make them more sensitive to the effects of metformin. Several observational studies have reported an association of early accelerated weight gain with an increased long-term risk of obesity. Therefore, further follow-up is needed to understand the impact of this sexual disparity in treatment effect on obesity in later years.
The Italian association of medical Diabetologists has published an excellent evidence-based position statement1 on the use of metformin therapy in pregnancy complicated by obesity, gestational diabetes (GDM), type 2 diabetes mellitus (T2DM), polycystic ovary syndrome (PCOS) and in women undergoing assisted reproductive technology (ART).
Reference: 1. Sciacca L, Bianchi C, Burlina S. et al. Position paper of the Italian Association of Medical Diabetologists (AMD), Italian Society of Diabetology (SID), and the Italian Study Group of Diabetes in pregnancy: Metformin use in pregnancy. Acta Diabetol (2023). 10.1007/s00592-023-02137-5.
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ESPE Yearbook of Paediatric Endocrinology
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