Metformin in women with type 2 diabetes in pregnancy (MiTy): a multi-center randomized controlled trial
نویسندگان
چکیده
BACKGROUND The incidence of type 2 diabetes in pregnancy is rising and rates of serious adverse maternal and fetal outcomes remain high. Metformin is a biguanide that is used as first-line treatment for non-pregnant patients with type 2 diabetes. We hypothesize that metformin use in pregnancy, as an adjunct to insulin, will decrease adverse outcomes by reducing maternal hyperglycemia, maternal insulin doses, maternal weight gain and gestational hypertension/pre-eclampsia. In addition, since metformin crosses the placenta, metformin treatment of the fetus may have a direct beneficial effect on neonatal outcomes. Our aim is to compare the effectiveness of the addition of metformin to insulin, to standard care (insulin plus placebo) in women with type 2 diabetes in pregnancy. METHODS The MiTy trial is a multi-centre randomized trial currently enrolling pregnant women with type 2 diabetes, who are on insulin, between the ages of 18-45, with a gestational age of 6 weeks 0 days to 22 weeks 6 days. In this randomized, double-masked, parallel placebo-controlled trial, after giving informed consent, women are randomized to receive either metformin 1,000 mg twice daily or placebo twice daily. A web-based block randomization system is used to assign women to metformin or placebo in a 1:1 ratio, stratified for site and body mass index. The primary outcome is a composite neonatal outcome of pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, or neonatal intensive care unit admission longer than 24 h. Secondary outcomes are large for gestational age, cord blood gas pH < 7.0, congenital anomalies, hyperbilirubinemia, sepsis, hyperinsulinemia, shoulder dystocia, fetal fat mass, as well as maternal outcomes: maternal weight gain, maternal insulin doses, maternal glycemic control, maternal hypoglycemia, gestational hypertension, preeclampsia, cesarean section, number of hospitalizations during pregnancy, and duration of hospital stays. The trial aims to enroll 500 participants. DISCUSSION The results of this trial will inform endocrinologists, obstetricians, family doctors, and other healthcare professionals caring for women with type 2 diabetes in pregnancy, as to the benefits of adding metformin to insulin in this high risk population. TRIAL REGISTRATION ClinicalTrials.gov Identifier: no. NCT01353391 . Registered February 6, 2009.
منابع مشابه
Metformin Therapy During Pregnancy
Type 2 diabetes and gestational diabetes mellitus (GDM) are closely related disorders characterized by increased insulin resistance. Metformin, a biguanide compound, exerts its clinical effect by both reducing hepatic glucose output and by increasing insulin sensitivity. This results in a decreased glucose level without an associated high risk of either hypoglycemia or weight gain. These charac...
متن کاملاثر متفورمین بر بهبود جریان خون رحمی- جفتی و کاهش عوارض حاملگی در خانم‌های حامله مبتلا به سندرم تخمدان پلی‌کیستی
Background: Some complications of pregnancy such as abortion, gestational diabetes mellitus, preeclampsia, and preterm delivery are more common among women with polycystic ovary syndrome (PCOS). Recently it has been reported that metformin treatment during pregnancy reduces pregnancy complications, so this study was conducted to demonstrate the possible effects of metformin on the uteroplacenta...
متن کاملComment on Koivusalo et al. Gestational Diabetes Mellitus Can Be Prevented by Lifestyle Intervention: The Finnish Gestational Diabetes Prevention Study (RADIEL): A Randomized Controlled Trial. Diabetes Care 2016;39:24–30
I read with great interest the recent article in Diabetes Care by Koivusalo et al. (1). In a randomized controlled trial, namely the Finnish Gestational Diabetes Prevention Study (RADIEL), Koivusalo et al. report that lifestyle intervention reduced the incidence of gestational diabetes mellitus (GDM) by 39% in pregnant women with a history of GDM and/or prepregnancy obesity (1). The authors hig...
متن کاملاثر متفورمین در کنترل قند خون بیماران دیابتی نوع دوم تحت درمان با انسولین
Background: Patients with type 2 diabetes are often obese and require large dose of insulin to achieve glycemic control. Insulin therapy often cause weight gain and results in increasing insulin requirements. This study was conducted to evaluate the efficacy of metformin in combination with insulin in patients with type 2 diabetes poorly controlled with insulin therapy alone. Materials and Meth...
متن کاملInvestigating the Impact of Metformin Consumption on the Incidence of Gestational Diabetes and Preeclampsia in Pregnant Women Suffering Polycystic Ovary Syndrome: A Clinical Trial Study
Background Women with polycystic ovary syndrome (PCOS) are at higher risk of developing pregnancy complications including gestational diabetes and preeclampsia. This study was performed with the aim of examining the impact of metformin on incidence of gestational diabetes and preeclampsia in pregnant women with PCOS. <s...
متن کامل