A Multi-centre Follow up Study of the Effect of In-utero Exposure to Metformin in 5-11 Year Old Offspring of Mothers in the MiTy Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 24
- 主要终点
- Body Mass Index (BMI) z-score
研究概览
简要总结
The incidence of diabetes in pregnancy is rising, with rates of 1 in 7 pregnancies globally. Metformin is used for type 2 diabetes (T2DM) outside of pregnancy and is now increasingly prescribed during pregnancy. There are some concerns as metformin crosses the placenta and effects on offspring exposed during pregnancy are unknown. Animal and human evidence indicate that metformin may create an atypical in-utero environment similar to under-nutrition which has been associated with adult obesity. This is supported by studies in children of mothers treated with metformin in other populations where an increase in childhood obesity was found at 4-9 years of age. We now have evidence from the MiTy trial, that offspring of metformin-exposed women with T2DM have less large infants and are less adipose at birth, but are also more likely to be small for gestational age (SGA). These effects could lead to benefit or harm in the long-term. Offspring of MiTy mothers are currently being followed up to 2 years. Given that long-term effects may not be evident until 5 years of age, it is imperative to follow these children longer.
Goals/Research Aims:To determine whether in-utero exposure to metformin, in offspring of women with T2DM, is beneficial or harmful in the long-term.
Research Questions: 1. In offspring of women with T2DM, how does treatment with metformin during pregnancy affect a) adiposity b) growth over time c) metabolic syndrome d) cognitive and behavioral measures:2. What factors predict altered childhood adiposity and insulin resistance in these offspring?
Primary Outcome: Body mass index (BMI) z-score.
Secondary Outcomes: 1) other measures of adiposity (i.e. skinfolds, 2) growth over time 3) measures of insulin resistance 4) adipocytokines 5)neurodevelopment
Expected Outcomes Given these increasing concerns, this study will inform the best treatment for pregnant mothers with diabetes by studying the long-term outcomes of children exposed to metformin during pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liveborn offspring of women who participated in the MiTy trial.
排除标准
- •Offspring with major congenital anomalies that would affect growth or development (these children have already been excluded from MiTy Kids).
研究组 & 干预措施
Metformin exposed in utero
Offspring of mothers who were exposed to metformin during pregnancy in the MiTy trial.
Placebo exposed in utero
Offspring of mothers who were not exposed to metformin during pregnancy in the MiTy trial.
结局指标
主要结局
Body Mass Index (BMI) z-score
时间窗: 5-11 years of age
Using WHO or other appropriate growth charts
次要结局
- Neurocognitive development(5-11 years of age)
- Triceps skinfolds z-scores(5-11 years of age)
- Waist to height ratio(5-11 years of age)
- Skinfold measurements(5-11 years of age)
- Sum of skinfold measurements:(5-11 years of age)
- Overweight and obesity status(5-11 years of age)
- Growth trajectory(5-11 years of age)
- Measures of insulin resistance and metabolic syndrome(5-11 years of age)
- Fat mass(5-11 years of age)
- Percentage of body fat(5-11 years of age)
- Waist circumference(5-11 years of age)
- Ratio of the central to peripheral skinfold ratio(5-11 years of age)