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NCT Number: NCT01623934

Role of Adipokines in Glucose Regulation During Pregnancy and in Fetal Development

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, 5 and 10-12 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, 5 and 10 years of age.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnosis of gestational diabetes mellitus

    Time frame: 24-28 weeks of gestation

    75g oral glucose tolerance test

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • American Diabetes Association
  • Canadian Institutes of Health Research (CIHR)
  • Diabetes Québec
  • Fonds de la Recherche en Santé du Québec

Registry information

Acronym: GEN3G

Important dates

Study start
2010
Primary completion
2025
Study completion
2025
First posted
Jun 20, 2012
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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