Genetic and Epigenetic Mechanisms of Developing Gestational Diabetes Mellitus and Its Effects on the Fetus

Not Applicable

• Conditions: Gestational Diabetes Mellitus
• Interventions: Other: Life-style modification, insulin therapy if needed

• Registration Number: NCT03610178
• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Brief Summary

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.

Detailed 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 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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-08-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12
• Primary Completion: 2020-05
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 850

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tight-moderate glycemic targets	Life-style modification, insulin therapy if needed	-
very tight glycemic targets	Life-style modification, insulin therapy if needed	-

Primary Outcome Measures

Name	Time	Method
TRIB1	within 24 hours after delivery	Level of expression of TRIB1 gene
ANGPTL4	within 24 hours after delivery	Level of expression of ANGPTL4 gene
NR3C1	within 24 hours after delivery	Level of expression of NR3C1 gene
LEP	within 24 hours after delivery	Level of expression of LEP gene
LGA newborns	within 24 hours after delivery	Number (%) of large for gestational age (LGA) newborns
ADIPOQ	within 24 hours after delivery	Level of expression of ADIPOQ gene

Secondary Outcome Measures

Name	Time	Method
Cesarian sections	within 24 hours after delivery	Number (%) of deliveries by Cesarian sections
SGA newborns	within 24 hours after delivery	Number (%) of small for gestationa age (SGA) newborns
Methylation of candidate genes	within 24 hours after delivery	Levels of methylation (%) of candidate genes with confirmed differences in the expression in HUVECs isolated within 24 hours after delivery

Trial Locations

Locations (1)

Almazov NMRC; 🇷🇺 Saint Petersburg, Russian Federation