Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial (MiTy Kids)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 1
- 主要终点
- Adiposity in the offspring
研究概览
简要总结
The prevalence of diabetes in pregnancy is rising in all maternal age groups. There is increasing evidence that in-utero exposure to maternal diabetes is associated with an increased risk of obesity and type 2 diabetes in children and adults. There is an urgent need to reduce these increasing rates of obesity and diabetes in subsequent generations.
The MiTy Trial (Metformin in Women with Type 2 Diabetes in Pregnancy Trial) is a CIHR-funded multi-centre, randomized controlled trial of women with type 2 diabetes in pregnancy (sample size n=500). The MiTy Trial is looking to determine the effect of the addition of metformin to a standard regimen of insulin in women with diabetes, on perinatal morbidity and mortality.
The MiTy Kids Trial is a follow-up to the MiTy Trial which will determine whether treatment with metformin during pregnancy in women with type 2 diabetes will lead to a reduction in adiposity and improvement in insulin resistance in the offspring of women with diabetes at 2 years of age.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Offspring of women with type 2 diabetes who participated (or are participating) in the MiTy trial.
排除标准
- •Offspring with major congenital anomalies.
结局指标
主要结局
Adiposity in the offspring
时间窗: 24 months
Anthropometric measures: BMI and sum of skinfolds (triceps, subscapular, suprailiac and biceps).
次要结局
- Sum of skinfolds in the offspring(6, 12 and 24 months)
- Central to peripheral adiposity in the offspring(6, 12 and 24 months)
- Weight gain, BMI and weight-for-length percentile change over time in critical early periods and overall in the offspring.(3, 6, 12, 18 and 24 months)
- Overweight and obesity in the offspring(3, 6, 12, 18 and 24 months)
- Insulin resistance in the offspring(24 months)
- adipocytokine profile in the offspring(24 months)