Abstract
BackgroundThe prevalence of Gestational Diabetes (GDM) is rising and with it the number of mothers and children at risk of adverse outcomes. As treatment has been shown to reduce adverse events, it is imperative that we identify all at-risk pregnant women. In Ireland, the national standard of care is selective screening with a 2-hour 75 g oral glucose tolerance test (OGTT). Aiming for universal screening is of utmost importance but this is difficult given the length, the unfeasibility and impracticability of the OGTT. We aim to assess if the novel biomarker glycated CD59 (gCD59) is a suitable contender for the OGTT in identifying women with GDM.MethodsIn this prospective cohort study, the study participants will be consecutive pregnant women at Galway University Hospital, Galway, Ireland. Samples for the plasma gCD59 biomarker will be taken together with routine bloods at the first antenatal visit, at weeks 24–28 at the time of routine 75 g OGTT, in trimester 3- and 12-weeks post-partum for women with GDM while having their routine post-partum 75 g OGTT. The constructed database will contain baseline information on each study participant, baseline laboratory data, follow-up laboratory data and pregnancy related outcomes. We aim to recruit a total of 2,000 participants over the project period and with a national GDM prevalence of 12–13%, we will have 240–260 subjects who meet OGTT criteria for GDM. Following regional prevalence, we expect to have 34–37 women who will develop either diabetes or pre-diabetes in the early post-partum period. The sensitivity and specificity of plasma gCD59 to predict the results of the OGTT will be assessed using nonparametric estimates of the receiver operating characteristic (ROC) curves and respective area under the ROC curve (AUROC).DiscussionA body of clinical and experimental evidence supports a link between the complement system, complement regulatory proteins, and the pathogenesis of diabetes complications.Building on this research, our study plans to look at the plasma gCD59 capacity to classify pregnant women with normal or abnormal glucose tolerance but also to assess if plasma gCD59 can be used as an early predictor for GDM, for adverse pregnancy outcomes and/or post-partum glucose intolerance.
Highlights
The prevalence of Gestational Diabetes (GDM) is rising and with it the number of mothers and children at risk of adverse outcomes
Bogdanet et al BMC Pregnancy and Childbirth (2020) 20:412 (Continued from previous page) normal or abnormal glucose tolerance and to assess if plasma glycated CD59 (gCD59) can be used as an early predictor for GDM, for adverse pregnancy outcomes and/or post-partum glucose intolerance
A body of clinical and experimental evidence supports a link between the complement system, complement regulatory proteins, and the pathogenesis of diabetes complications [27,28,29,30,31]
Summary
The prevalence of Gestational Diabetes (GDM) is rising and with it the number of mothers and children at risk of adverse outcomes. As treatment has been shown to reduce adverse events, it is imperative that we identify all at-risk pregnant women. Gestational diabetes is a global epidemic that causes adverse maternal and infant outcomes and identifies the mother-child pair at risk of future diabetes, obesity and cardiovascular disease [1,2,3,4]. Selective screening for GDM with a 75 g OGTT is the current Irish national standard of care for all at-risk pregnant women without established diabetes [8]. Universal screening is difficult to achieve currently because the standard OGTT has to be done fasting, is lengthy, cumbersome for the woman and the health service, and has poor reproducibility [10,11,12]. Researchers are working to identify biomarkers that may replace the OGTT and allow universal screening to become a reality
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