Genetic and Epigenetic Mechanisms of Developing Gestational Diabetes Mellitus and Its Effects on the Fetus
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Gestational Diabetes Mellitus
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Women with GDM are randomised to 2 treatment groups: group 1 - treatment group with very tight glycemic targets (<5.1 mmol / L fasting glucose and <7.0 mmol / l hour after a meal) and group 2 - treatment group with tight-moderate glycemic targets (<5.3 mmol / L fasting glucose and <7.8 mmol / l in an hour after a meal).Masking: Single (Investigator)Primary Purpose: Basic Science
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Only males
Description
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...
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.
Tracking Information
- NCT #
- NCT03610178
- Collaborators
- Not Provided
- Investigators
- Study Director: Griniva Elena, MD, PhD Almazov NMRC
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