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

Gestational Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03610178
• Other study ID #: 15-14-30012
• Status: Recruiting
• Phase: N/A
• Start date: August 2015
• Est. completion date: July 2020

Study information

• Verified date: February 2020
• Source: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Contact: Polina Popova, MD, PhD
• Phone: +78127550595
• Email: pvpopova[@]yandex.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: July 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Other:
• Life-style modification, insulin therapy if needed
All patients are assigned to life-style modification (diet and physical exercise). If target glucose levels (<5.1 mmol/L fasting and <7.0 mmol/L postprandial) are not achieved insulin therapy is started
• Life-style modification, insulin therapy if needed
All patients are assigned to life-style modification (diet and physical exercise). If target glucose levels (<5.3 mmol/L fasting and <7.8 mmol/L postprandial) are not achieved insulin therapy is started

Locations

Country	Name	City	State
Russian Federation	Almazov NMRC	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LGA newborns	Number (%) of large for gestational age (LGA) newborns	within 24 hours after delivery
Primary	TRIB1	Level of expression of TRIB1 gene	within 24 hours after delivery
Primary	LEP	Level of expression of LEP gene	within 24 hours after delivery
Primary	ADIPOQ	Level of expression of ADIPOQ gene	within 24 hours after delivery
Primary	ANGPTL4	Level of expression of ANGPTL4 gene	within 24 hours after delivery
Primary	NR3C1	Level of expression of NR3C1 gene	within 24 hours after delivery
Secondary	Cesarian sections	Number (%) of deliveries by Cesarian sections	within 24 hours after delivery
Secondary	SGA newborns	Number (%) of small for gestationa age (SGA) newborns	within 24 hours after delivery
Secondary	Methylation of candidate genes	Levels of methylation (%) of candidate genes with confirmed differences in the expression in HUVECs isolated within 24 hours after delivery	within 24 hours after delivery