EMPOWaR-INFO study

  • Research type

    Research Study

  • Full title

    EMPOWaR-INFO study: the influence of metformin on child’s development at age 4-7

  • IRAS ID

    224908

  • Contact name

    Rebecca Reynolds

  • Contact email

    R.Reynolds@ed.ac.uk

  • Sponsor organisation

    University of Edinburgh

  • Duration of Study in the UK

    2 years, 8 months, 0 days

  • Research summary

    One in five pregnant women in UK are obese and their children are at increased risk of becoming obese themselves and developing heart disease in their later life. One of the potential reasons is that the baby born to an obese mother is exposed to higher blood sugar levels in the womb than babies born to normal weight mothers. The exposure to high blood sugar levels is thought to be a reason that could increase children’s risk of later life disease. In the EMPOWaR study, women were randomized to take either metformin (a drug which lowers blood sugar) or placebo (a dummy tablet) during pregnancy. Although there were no differences in baby birthweight, there were some indications that metformin may have beneficial effects on the baby’s development. For example, the babies tended to be slightly thinner if their mothers took metformin rather than placebo. Mothers who took metformin also had slightly lower weight gain in pregnancy and had lower levels of blood glucose and inflammation factors. We now want to investigate if the metformin treatment had any long term effect on the the children’s develoment. Our EMPOWaR Infant Follow-up (EMPOWaR-INFO) study is a follow-up study of the children (now aged 4-7 years) born to obese women who participated in the trial and took either metformin or placebo in pregnancy. The aim of this study is to determine whether there are long term benefits of metformin treatment on the offspring development. We will arrange a clinic visit for the parents and their children who agree to participate. The research team will weigh and measure the children to assess their body composition We will also collect mouth swab samples from the child. The parent will be asked to complete some questionnaires about their child’s diet, behaviour and activity levels.

  • REC name

    South East Scotland REC 01

  • REC reference

    17/SS/0065

  • Date of REC Opinion

    23 May 2017

  • REC opinion

    Further Information Favourable Opinion