OPHELIA study - Causes of Gestational Diabetes
Research type
Research Study
Full title
OPHELIA: Observational study in pregnancy hyperglycaemia: endocrine causes, lipids, insulin and autoimmunity
IRAS ID
238504
Contact name
Claire Meek
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust & University of Cambridge
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Gestational diabetes (GDM) affects approximately 35,000 pregnancies in the UK every year and is associated with adverse pregnancy outcomes affecting both mother and child. Although most cases of GDM are thought to occur due to pregnancy-hormone-induced insulin resistance, there is likely to be some variation in the contribution of autoimmunity, insulin resistance, insulin insufficiency and pregnancy hormone concentrations to the disease process. In addition, a minority of women diagnosed with GDM will be actively developing early type 1 or type 2 diabetes, and these women are likely to have greater pregnancy-related risks. The aim of this study is to identify pathophysiological differences in women with GDM by measuring autoantibodies, insulin and hormone concentrations, and to assess how these differences might affect pregnancy outcomes. Women will be invited to participate after a clinical referral for an antenatal oral glucose tolerance test (OGTT) and will have extra blood taken for research purposes while undergoing venesection for clinical reasons. Data from biochemistry and obstetric databases will be linked and analysed anonymously to permit assessment of pregnancy outcomes.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/0477
Date of REC Opinion
6 Apr 2018
REC opinion
Further Information Favourable Opinion