GUARD
Research type
Research Study
Full title
Randomised controlled trial of Gestational treatment with Ursodeoxycholic Acid compared to Metformin to Reduce effects of Diabetes mellitus
IRAS ID
1003208
Contact name
Caroline Ovadia
Contact email
Sponsor organisation
King's College London
Eudract number
2019-002880-82
Research summary
Each year in the UK approximately 35,000 women develop diabetes during pregnancy, a
condition called gestational diabetes mellitus (GDM), which increases the risk of adverse
outcomes for both mother and child. Metformin, although unlicensed for used in
pregnancy, is the most commonly used first line pharmacological treatment. However,
there is increasing concern about its widespread use during pregnancy, because of its
limited efficacy and because of potential safety concerns. Other common treatments have
not been shown to be superior. Therefore, there is an unmet need for additional
therapies.
Ursodeoxycholic acid (UDCA) is commonly used in pregnancy for the treatment of
intrahepatic cholestasis of pregnancy. It is currently not an established/licensed
treatment for GDM. However data from observational studies of women with cholestasis
in pregnancy has flagged this to be a potential effective treatment to control blood
glucose levels in GDM.
GUARD is a Clinical Trial that wants to explore the impact of UDCA compared to
metformin in the treatment of GDM. We want to recruit 158 women who are overweight
or obese who have been diagnosed with GDM, and require pharmacological treatment.
Glucose control is our primary measure. We will ask women to attend three study visits,
which will coincide with the time of their antenatal appointments. We want to collect a
range of clinical and research blood samples, to measure quality of life and treatment
satisfaction through two questionnaires, and we will ask women to wear a continuous
glucose monitor for three 10 day periods.
There will be a number of optional assessments that participants will be offered. The
primary outcome will be the fasting blood glucose concentration at 36 weeks of gestation.
We intend to carry out this study at 3 sites (Guy’s and St Thomas, Imperial College and
Nottingham), and it has been funded by a J.P Moulton Foundation grant.REC name
London - Westminster Research Ethics Committee
REC reference
20/LO/0504
Date of REC Opinion
5 May 2020
REC opinion
Further Information Favourable Opinion