Metformin vs Control to Prevent Gestational Diabetes Mellitus (GDM) in Women With a High Risk for GDM, an Open Label Randomized Controlled Trial, The Medico-GDM Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- incidence of gestational diabetes mellitus in both groups
研究概览
简要总结
Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high risk for GDM, an open label randomized controlled trial' The Medico-GDM trial
详细描述
Rationale: GDM is a frequent pregnancy complication1 and associated with complications for mother and child.2 At present, the drug of choice for treatment of GDM is Insulin.3 In the last years several studies documented the use of oral blood glucose lowering medication in GDM. Metformin is an accepted alternative for insulin, with comparable glycemic control and neonatal outcomes.4 In studies with women with polycystic ovarian syndrome (PCOS) who received Metformin during pregnancy, the incidence of GDM is less compared to pregnant women with PCOS without Metformin. These studies were however small and there was no adequate control group.5 Our aim is to study the effect of Metformin on the incidence of GDM in women with a high risk for GDM.
Objective: the primary objective is to compare metformin versus no intervention for incidence of GDM in women with a high risk for GDM. The main secondary objective is pregnancy outcome with Metformin, neonatal outcomes and neonatal complications.
Study design: 2 years open label randomized controlled trial, comparing metformin versus control group.
Study population: pregnant women with a high risk of GDM between 18 and 40 years old in the first trimester of pregnancy.
Intervention: the first group receives Metformin twice daily 500 mg for the first week, after that twice daily 1000 mg. The second group receives no intervention. All the subjects are receiving a diet which contains a 2000 calories/day diet, with an adequate distribution of carbohydrates during the day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •a subject must meet all of the following criteria:
- •high risk (according to ductch national criteria) for gestational diabetes
- •aged between 18 and 40 years
- •gestational age between 8 and 12 weeks
- •and able to communicate and read in Dutch.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •no singleton pregnancy judged by ultrasonography
- •diagnosis of diabetes mellitus before the current pregnancy-
- •high fasting glucose at first trimester (> 5.3 mmol/l)
- •cardiac insufficiency-\
- •renal insufficiency (MDRD < 60)
- •liver disease
- •use of medication other than Paracetamol or vitamins and incompetent women.
研究组 & 干预措施
intervention
Metformin twice daily 500 mg for the first week, after that twice daily 1000 mg. All the subjects are receiving a diet which contains a 2000 calories/day diet, with an adequate distribution of carbohydrates during the day.
干预措施: Metformin (Drug)
intervention
Metformin twice daily 500 mg for the first week, after that twice daily 1000 mg. All the subjects are receiving a diet which contains a 2000 calories/day diet, with an adequate distribution of carbohydrates during the day.
干预措施: control diet (Other)
control diet
a diet which contains a 2000 calories/day diet, with an adequate distribution of carbohydrates during the day.
干预措施: control diet (Other)
结局指标
主要结局
incidence of gestational diabetes mellitus in both groups
时间窗: from 14 weeks pregnancy untill delivery
次要结局
- Neonatal outcomes(from 14 weeks pregnancy untill delivery)
- Maternal outcomes(from 14 weeks pregnancy untill delivery)
研究者
Wetenschapsbureau
dr. J. van der Linden
Maasstad Hospital