UPBEAT-TIF
Research type
Research Study
Full title
Prevention of Gestational Diabetes in Obese Pregnant Women; a Proof of Principle Study Targeting Early Pregnancy Intervention to Women at Risk
IRAS ID
235666
Contact name
Sara White
Contact email
Sponsor organisation
King's College London
Eudract number
2018-000003-16
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Obesity in pregnancy increases the risk of gestational diabetes (GDM) and associated adverse outcomes. UK guidelines recommend that all obese women have an oral glucose tolerance test at 24-28 weeks’ gestation for detection of GDM. However, excessive fetal growth in obese women is evident before diagnosis of GDM, accompanied by an abnormal metabolome (small chemicals which are products of metabolism), reported from our research group. Targeted early pregnancy intervention is therefore required to prevent GDM and improve clinical outcomes in obese women. We have recently developed an early pregnancy GDM prediction tool. This study addresses the hypothesis that early pregnancy dietary advice and/or metformin (a drug to reduce blood sugar levels), the two ‘first line’ treatments for women with established GDM, will prevent gestational diabetes by improving glucose tolerance and metabolic function in obese pregnant women identified as 'at risk' by this prediction tool.
In this study, women at high risk of GDM will have the opportunity to take part in a single centre, unblinded randomised controlled trial and will be assigned into one of 3 groups; 1) dietary advice, 2) dietary advice plus metformin or 3) standard antenatal care. Women who receive dietary advice will attend weekly sessions which will focus on swapping foods that have a high glycaemic index (GI) and are high in saturated fat for those that have a lower GI and saturated fat content. Women prescribed metformin will take the drug until delivery. To examine if the intervention is successful, the women will be asked to wear a continuous glucose monitor before and after the intervention and in late pregnancy.
The research is funded by the Wellcome Trust and Rosetrees Trust and will recruit from the antenatal clinics of St Thomas' Hospital in London.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/1500
Date of REC Opinion
6 Nov 2018
REC opinion
Further Information Favourable Opinion