EMmY - Preventing Gestational Diabetes with myo-inositol supplement
Research type
Research Study
Full title
Effectiveness and acceptability of myo-inositol nutritional supplement in the prevention of gestational diabetes: a pilot placebo controlled double blind randomised trial
IRAS ID
232904
Contact name
Shakila Thangaratinam
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
1 years, 8 months, days
Research summary
Gestational diabetes, a condition with raised glucose levels that is first diagnosed in pregnancy, increases the risk of complications to mothers and their babies. There is a need for an effective, simple, acceptable and safe treatment to prevent gestational diabetes, which affects 1800 women every year in Barts Health Trust alone. Our systematic review identified the promising role of the nutritional supplement myo-inositol in reducing the risk of GDM. To date, small studies have identified the potential role of over-the-counter nutritional supplement myo-inositol in preventing gestational diabetes. The uptake of the intervention in mothers from inner city NHS trusts, which care for multi-ethnic, high-risk women is not known.
Prior to investing resources into a large-scale study (approx. £1.7 million) on testing the effectiveness of myo-inositol to reduce the incidence of GDM, we propose to undertake a smaller version (200 women) of the future large trial. We propose to undertake a multi centre, randomised, placebo controlled, double blind pilot trial (EMmY), on myo-inositol supplementation in pregnancy to prevent GDM, to inform the large-scale definitive randomised trial. We will evaluate the study process, examine the acceptability of the study and intervention to mothers, and identify reasons for non-participation and non-retention. We will also obtain preliminary estimates of effects of myo-inositol on glycaemic parameters, and develop a core outcome set to be minimally reported in trials on prevention of GDM.
REC name
London - Queen Square Research Ethics Committee
REC reference
17/LO/1741
Date of REC Opinion
22 Dec 2017
REC opinion
Further Information Favourable Opinion