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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Zoe Drymoussi
+44 (0)2078826692
z.drymoussi@qmul.ac.uk


Study Location:

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Be Part of Research - Trial Details - Preventing type 2 diabetes with metformin
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Preventing type 2 diabetes with metformin

Not Recruiting

Open to: Female

Age: Adult

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Medical Conditions

Specialty: Reproductive Health and Childbirth, Primary sub-specialty: Maternal/ Fetal medicine
UKCRC code/ Disease: Reproductive health and childbirth/ Other maternal disorders predominantly related to pregnancy

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This study compares metformin versus placebo (dummy drug) for 1 year after delivery to prevent type 2 diabetes in women diagnosed with gestational diabetes in pregnancy. The aim of this study is to evaluate the study process, examine the acceptability of the intervention to mothers, and identify reasons for non-participation, non-adherence and withdrawal from the study. The study will also obtain preliminary estimates of the effects of metformin in preventing type 2 diabetes to inform a larger trial.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 Aug 2018 15 Jan 2019

Publications

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32423937/ protocol (added 15/01/2021)2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38016790/ (added 30/11/2023)

Participants are randomly allocated to take either metformin or a placebo for a period of 1 year, during which time they are asked to attend three hospital visits to assess compliance, side effects and type 2 diabetes status. Some of the participants are also interviewed to assess the acceptability of the study.


Women aged 16 or over who have been diagnosed with gestational diabetes in pregnancy and are taking either insulin or metformin

You can take part if:



You may not be able to take part if:


1. Women unable to give informed, written consent in English2. Pre-existing type 1 diabetes or type 2 diabetes3. BMI > = 40 kg/m24. Known contraindications to metformin 5. Concurrent participation in another interventional clinical trial


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal London Hospital
    E1 1BB
  • Whipps Cross University Hospital
    E11 1NR
  • Newham University Hospital
    E13 8SL

The results of this study will aid the development of further trials examining the effectiveness of metformin at preventing type 2 diabetes in women with gestational diabetes. Patients may experience side effects from taking metformin. At the start of the treatment, the most common side effects are nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. To prevent these, the dose will be adjusted for women who have not previously taken the medication to minimise any of these potential side effects. Very rare side effects (<1/10,000) from metformin include: lactic acidosis; decreased vitamin B12 absorption with decrease of blood levels during long-term use of metformin; isolated reports of liver function tests abnormalities or hepatitis resolving upon stopping metformin; and skin reactions such as erythema, pruritus and urticaria. Metformin is excreted into human breast milk but no side effects have been observed in breastfed newborns/infants. The research team will maintain contact with the participants throughout the study to monitor any side effects and advise accordingly. Participants will have an emergency number to contact, should they need to speak to a clinician out of hours. Participants may have bruising, bleeding or discomfort from the blood samples. However, these are part of routine care and will be performed by a qualified member of the research team or a phlebotomist.

Dr Zoe Drymoussi
+44 (0)2078826692
z.drymoussi@qmul.ac.uk



The study is sponsored by Queen Mary University of London and funded by Merck KGaA; Barts Charity.



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Read full details for Trial ID: ISRCTN20930880
Last updated 30 November 2023

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