NCT03610178已完成不适用

Genetic and Epigenetic Mechanisms of Developing Gestational Diabetes Mellitus and Its Effects on the Fetus: a Randomised Controlled Trial of Different Glycemic Targets During Pregnancy

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health2 个研究点分布在 1 个国家目标入组 850 人开始时间: 2015年8月1日最近更新: 2025年11月21日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 850
试验地点: 2
主要终点: TRIB1

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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 trial, open-label.

详细描述

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.

This clinical trial record primarily describes the overarching observational cohort study "Genetic and Epigenetic Mechanisms of Developing Gestational Diabetes Mellitus and Its Effects on the Fetus" including women with GDM and healthy pregnant women.

Substudy Protocol: A key predefined component of this larger study is an interventional, randomized controlled substudy entitled "Tight versus less tight glycaemic targets for women with gestational diabetes mellitus: a randomised controlled trial" (also known as the GEM GDM Trial).

The GEM GDM Trial is an open-label, randomized controlled trial (RCT) that compares the effects of tight (very tight) versus less tight (tight-moderate) glycemic control on maternal and neonatal outcomes in women diagnosed with Gestational Diabetes Mellitus (GDM). Participants from the main GEM cohort who are diagnosed with GDM according to International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria are eligible for screening and subsequent randomization into this substudy.

The substudy aims to enroll 650 pregnant women with a singleton pregnancy and GDM, randomly assigning them in a 1:1 ratio to one of two glycemic target groups.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: None (Investigator)

入排标准

性别: Female
接受健康志愿者: 否

入选标准

•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.

排除标准

•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.