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

NCT03610178 | Completed

• 1 other identifier: 15-14-30012
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

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 trial, open-label.

Conditions

Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (6)

• LGA newborns

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

  within 24 hours after delivery

• TRIB1

  Level of expression of TRIB1 gene

  within 24 hours after delivery

• LEP

  Level of expression of LEP gene

  within 24 hours after delivery

• ADIPOQ

  Level of expression of ADIPOQ gene

  within 24 hours after delivery

• ANGPTL4

  Level of expression of ANGPTL4 gene

  within 24 hours after delivery

• NR3C1

  Level of expression of NR3C1 gene

  within 24 hours after delivery

Secondary Outcomes (40)

• Cesarian sections

  within 24 hours after delivery

• SGA newborns

  within 24 hours after delivery

• Methylation of candidate genes

  within 24 hours after delivery

• rate of macrosomia

  delivery

• birthweight

  delivery

Other Outcomes (4)

• HbA1c

  36 week

• fasting glucose

  36 week

• lipid profile

  36 week

Study Arms (3)

very tight glycemic targets

ACTIVE COMPARATOR

Other: Very tight glycemic targets, life-style modification, insulin therapy if needed

tight-moderate glycemic targets

ACTIVE COMPARATOR

Less tight glycemic targets

Other: Tight-moderate glycemic targets, life-style modification, insulin therapy if needed

Control group

NO INTERVENTION

Only observation in women with normal glucose tolerance

Interventions

Very tight glycemic targets, life-style modification, insulin therapy if needed OTHER

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

Also known as: Tight glycemic targets

very tight glycemic targets

Tight-moderate glycemic targets, life-style modification, insulin therapy if needed OTHER

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

tight-moderate glycemic targets

Eligibility Criteria

• Gender Eligibility Details: Gestation
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• For control group: pregnant women with normal glucose tolerance confirmed by OGTT at 24-31 weeks of gestation.

You may not qualify if:

• Diabetes mellitus type 1 and tipe 2
• Other deseases that affect methabolism of carbohydrates
• Use of drugs that affect methabolism of carbohydrates

Sponsors & Collaborators

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

Study Sites (1)

Almazov NMRC

Saint Petersburg, 197341, Russia

Location

Related Publications (1)

• Hofer OJ, Martis R, Alsweiler J, Crowther CA. Different intensities of glycaemic control for women with gestational diabetes mellitus. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD011624. doi: 10.1002/14651858.CD011624.pub3.

  PMID: 37815094 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Griniva Elena, MD, PhD

  Almazov NMRC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: August 1, 2018
• Study Start: August 1, 2015
• Primary Completion: June 10, 2022
• Study Completion: December 1, 2024
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)