OMAhA - preventing type 2 diabetes with metformin
Research type
Research Study
Full title
Effectiveness and acceptability of metformin in preventing onset of type 2 diabetes after gestational diabetes in postnatal women: A feasibility study for a randomised, blinded, placebo-controlled trial
IRAS ID
238230
Contact name
Shakila Thangaratinam
Contact email
Sponsor organisation
Joint Research Managment Office
Eudract number
2017-004535-37
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
A single site, double blind, randomised controlled feasibility study of metformin versus placebo for 1 year post-delivery to prevent type 2 diabetes in women diagnosed with gestational diabetes in pregnancy.
The study will be conducted at Barts Health NHS trust and will recruit 200 women and randomise 160. Women who have been diagnosed with gestational diabetes in pregnancy and are taking either insulin or metformin are eligible. Participants will be consented any time during their antenatal pathway after 16 weeks gestation and randomised after delivery. Women will be randomised to either metformin or a placebo for a period of 1 year, during which time they will be asked to attend 3 hospital visits to assess compliance, assess adverse events and check type 2 diabetes status. There will also be a qualitative arm of the study, for a proportion of participants, where acceptability of the study and other socio-economic factors will be explored in more detail.
The aim of the 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. We will also obtain preliminary estimates of effects of metformin in preventing type 2 diabetes to inform a larger randomised controlled trial.
REC name
London - Brent Research Ethics Committee
REC reference
18/LO/0505
Date of REC Opinion
17 May 2018
REC opinion
Further Information Favourable Opinion