Overview

This trial is active, not recruiting.

Conditions gestational diabetes, insulin resistance
Sponsor Université de Sherbrooke
Collaborator Fonds de la Recherche en Santé du Québec
Start date January 2010
End date January 2019
Trial size 1086 participants
Trial identifier NCT01623934, DG2A1

Summary

This study includes 2 phases. During phase 1, pregnant women are followed over the course of pregnancy. The phase 2 is a follow-up of the mother-child dyad at 3 and 5 year after delivery.

The purpose of this phase 1 is to :

- assess the contribution and interactions of adipokines in the development of insulin resistance during pregnancy and gestational diabetes;

- assess levels of maternal adipokines as determinants of development and fetal growth;

- determine the genetic variations that influence levels of adipokines and glucose regulation during pregnancy and in newborns.

The purpose of this phase 2 is to:

- identify DNA methylation variations at birth that are predictive of childhood overweight/obesity.

- identify maternal characteristics associated with DNA methylation variations predictive of childhood overweight/obesity.

- establish whether the loci predictive of childhood overweight/obesity at birth are still differentially methylated at 5 years of age (samples collected at 5 years of age).

- identify DNA methylation variations at birth that are predictive of childhood neurodevelopment problems at 3 and 5 years of age.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Diagnosis of gestational diabetes mellitus
time frame: 24-28 weeks of gestation

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - age ≥ 18 yrs - gestational age between 6 and 13 weeks from last menstrual period - no recognized diabetes or drugs interfering with glucose metabolism - alcohol < 2 drinks/day - not involved in regular high intensity physical activity - otherwise good health status Exclusion Criteria: - twin pregnancy

Additional Information

Official title Role of Adipokines in Glucose Regulation During Pregnancy and in Fetal Development
Principal investigator Marie-France Hivert, MD, MSc
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Université de Sherbrooke.