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

Primary Purpose

Gestational Diabetes Mellitus

Status

Unknown status

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Life-style modification, insulin therapy if needed

About this trial

This is an interventional basic science trial for Gestational Diabetes Mellitus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Almazov NMRCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

very tight glycemic targets

tight-moderate glycemic targets

Control group

Arm Description

Only observation in women with normal glucose tolerance

Outcomes

Primary Outcome Measures

LGA newborns

Number (%) of large for gestational age (LGA) newborns

TRIB1

Level of expression of TRIB1 gene

LEP

Level of expression of LEP gene

ADIPOQ

Level of expression of ADIPOQ gene

ANGPTL4

Level of expression of ANGPTL4 gene

NR3C1

Level of expression of NR3C1 gene

Secondary Outcome Measures

Cesarian sections

Number (%) of deliveries by Cesarian sections

SGA newborns

Number (%) of small for gestationa age (SGA) newborns

Methylation of candidate genes

Levels of methylation (%) of candidate genes with confirmed differences in the expression in HUVECs isolated within 24 hours after delivery

Full Information

NCT ID

NCT03610178

First Posted

November 13, 2017

Last Updated

February 11, 2020

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT03610178

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (Actual)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gestational Diabetes Mellitus

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Investigator

Allocation

Randomized

Enrollment

850 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

very tight glycemic targets

Arm Type

Active Comparator

Arm Title

tight-moderate glycemic targets

Arm Type

Active Comparator

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Only observation in women with normal glucose tolerance

Intervention Type

Other

Intervention Name(s)

Life-style modification, insulin therapy if needed

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Life-style modification, insulin therapy if needed

Intervention Description

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

Primary Outcome Measure Information:

Title

LGA newborns

Description

Number (%) of large for gestational age (LGA) newborns

Time Frame

within 24 hours after delivery

Title

TRIB1

Description

Level of expression of TRIB1 gene

Time Frame

within 24 hours after delivery

Title

LEP

Description

Level of expression of LEP gene

Time Frame

within 24 hours after delivery

Title

ADIPOQ

Description

Level of expression of ADIPOQ gene

Time Frame

within 24 hours after delivery

Title

ANGPTL4

Description

Level of expression of ANGPTL4 gene

Time Frame

within 24 hours after delivery

Title

NR3C1

Description

Level of expression of NR3C1 gene

Time Frame

within 24 hours after delivery

Secondary Outcome Measure Information:

Title

Cesarian sections

Description

Number (%) of deliveries by Cesarian sections

Time Frame

within 24 hours after delivery

Title

SGA newborns

Description

Number (%) of small for gestationa age (SGA) newborns

Time Frame

within 24 hours after delivery

Title

Methylation of candidate genes

Description

Levels of methylation (%) of candidate genes with confirmed differences in the expression in HUVECs isolated within 24 hours after delivery

Time Frame

within 24 hours after delivery

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Gestation

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Polina Popova, MD, PhD

Phone

+78127550595

pvpopova@yandex.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Griniva Elena, MD, PhD

Organizational Affiliation

Almazov NMRC

Official's Role

Study Director

Facility Information:

Facility Name

Almazov NMRC

City

Saint Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Polina Popova, MD, PhD

Phone

+78127025595

pvpopova@yandex.ru

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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