Genetic and Epigenetic Mechanisms of Developing Gestational Diabetes Mellitus and Its Effects on the Fetus
Genetic and Epigenetic Mechanisms of Developing Gestational Diabetes Mellitus and Its Effects on the Fetus
This is a randomized controlled trial of different glycemic targets during tratment of women
 with GDM with assessement of epygenetic aspects of their effects on the fetus and pregnancy
 outcomes. This study is interventional, randomised controlled trialr, open-label.
The study aims to clarify the effect of hyperglycemia and its correction, the level of
 physical activity and consumption of major macro- and micronutrients by women during
 pregnancy on DNA methylation and expression of genes involved in neuroendocrine regulation
 and development of metabolic diseases in offspring, as well as functional characteristics of
 human umbilical vein endothelial cells (HUVECs). For the purpose of the study women with GDM
 are randomised to 2 treatment groups per glycemic targets ( very tight and tight-moderate
 glycemic targets). Data on glycenmic levels during the study and consumption of major macro-
 and micronutrients will be collected using a mobile application with electronic dairies
 report forms.
Inclusion Criteria:

 -  Pregnant women with GDM diagnosed according to the Russian national consensus and the
 recommendations of the International Association of Diabetes and Pregnancy Study
 Groups (fasting glucose of ≥5.1 mmol/L, and/or ≥10.0 mmol/L after 1 h, and/or ≥8.5
 mmol/L after 2 h in oral glucose tolerance test (OGTT) with 75 g of glucose).

 -  Gestational age at the time of inclusion in the study 12 weeks 0 days - 31 weeks 6
 days

 -  For control group: pregnant women with normal glucose tolerance confirmed by OGTT at
 24-31 weeks of gestation.

 Exclusion Criteria:

 -  Diabetes mellitus type 1 and tipe 2

 -  Other deseases that affect methabolism of carbohydrates

 -  Use of drugs that affect methabolism of carbohydrates

 -  Malformations of the fetus identifired prior to inclusion to the study.