Clinical trial NCT03610178: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 850
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: LGA newborns
timeFrame: within 24 hours after delivery
measure: TRIB1
timeFrame: within 24 hours after delivery
measure: LEP
timeFrame: within 24 hours after delivery
measure: ADIPOQ
timeFrame: within 24 hours after delivery
measure: ANGPTL4
timeFrame: within 24 hours after delivery
measure: NR3C1
timeFrame: within 24 hours after delivery
Secondary outcomes:
measure: Cesarian sections
timeFrame: within 24 hours after delivery
measure: SGA newborns
timeFrame: within 24 hours after delivery
measure: Methylation of candidate genes
timeFrame: within 24 hours after delivery
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Almazov NMRC
Study officials:
affiliation: Almazov NMRC
name: Griniva Elena, MD, PhD
role: STUDY_DIRECTOR
References: