Screening of gestational diabetes mellitus in early pregnancy by oral glucose tolerance test and glycosylated fibronectin: study protocol for an international, prospective, multicentre cohort trial

Abstract

IntroductionAs the accurate diagnosis and treatment of gestational diabetes mellitus (GDM) is of increasing importance; new diagnostic approaches for the assessment of GDM in early pregnancy were recently suggested. We evaluate the diagnostic power of an ‘early’ oral glucose tolerance test (OGTT) 75 g and glycosylated fibronectin (glyFn) for GDM screening in a normal cohort.Methods and analysisIn a prospective cohort study, 748 singleton pregnancies are recruited in 6 centres in Switzerland, Austria and Germany. Women are screened for pre-existing diabetes mellitus and GDM by an ‘early’ OGTT 75 g and/or the new biomarker, glyFn, at 12–15 weeks of gestation. Different screening strategies are compared to evaluate the impact on detection of GDM by an OGTT 75 g at 24–28 weeks of gestation as recommended by the International Association of Diabetes and Pregnancy Study Groups (IADPSG). A new screening algorithm is created by using multivariable risk estimation based on ‘early’ OGTT 75 g and/or glyFn results, incorporating maternal risk factors. Recruitment began in May 2014.Ethics and disseminationThis study received ethical approval from the ethics committees in Basel, Zurich, Vienna, Salzburg and Freiburg. It was registered under http://www.ClinicalTrials.gov (NCT02035059) on 12 January 2014. Data will be presented at international conferences and published in peer-reviewed journals.Trial registration numberNCT02035059.

High Fasting Plasma Glucose during Early Pregnancy: A Review about Early Gestational Diabetes Mellitus

“…There is a need to investigate the best threshold for early FPG and the association with late GDM or poor pregnancy outcomes. The concordances of early OGTT, at 12–15 WG [ 38 ] or at 18–20 WG [ 39 ], are going to be compared to OGTT results at 24–28 WG in two studies, but no data are currently available yet.…”

The protective effect of neonatal oral administration of oleanolic acid against the subsequent development of fructose-induced metabolic dysfunction in male and female rats

“…At the end of the 16 week study period (PD110), an oral glucose tolerance test (OGTT) was performed after an overnight fast. Briefly, fasting blood glucose was determined and then each rat was administered with a dose of 2 g/kg body mass of sterile 50% ( w / v ) D-glucose solution (Sigma, Johannesburg, South Africa) via orogastric gavage [ 65 ]. Thereafter blood glucose concentrations were measured at T = 15, 30, 60, 120 and 180 min using a calibrated glucometer (Contour Plus® glucometer, Bayer (Pty) Ltd., Johannesburg, South Africa).…”

“…Data were expressed as mean ± standard deviation and analysed using GraphPad Prism for Windows Version 7.0 (GraphPad Software Inc., San Diego, USA). The baseline fasting glucose levels were subtracted from all other glucose values for each animal and the total area under the curve (AUC) for the OGTT was calculated by the trapezoidal method to assess glucose tolerance [ 65 ]. A two-way repeated measures analysis of variance (ANOVA), with Bonferroni post-hoc test, was used to analyse terminal body mass with day as a within-subjects factor and treatment as a between-subjects factor.…”

Mid‐trimester glycosylated hemoglobin levels (HbA1c) and its correlation with oral glucose tolerance test (World Health Organization 1999)

“…GDM is responsible for a number of maternal and fetal complications, thus its early diagnosis and management will help in reducing maternal and fetal complications and give better outcome …”

“…4 GDM is responsible for a number of maternal and fetal complications, thus its early diagnosis and management will help in reducing maternal and fetal complications and give better outcome. [5][6][7][8] Besides this, there has been much debate on screening and treatment of GDM. Oral glucose tolerance test (OGTT) has been traditionally accepted as a method for diagnosis; however, if we go into the details, almost all countries have different tests and there are as many as 10 different methods of doing OGTT with varying time intervals and varying glucose loads.…”