Role of Adipokines in Glucose Regulation During Pregnancy and in Fetal Development (GEN3G)

May 1, 2017 updated by: Marie-France Hivert, Université de Sherbrooke

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

1086

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H5N4
        • Centre de recherche Étienne-Le Bel, Centre hospitalier universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women when they come for their first prenatal visit at the Clinique de Prélèvements et de Recherche en Grossesse.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Phase 1: Pregnant women
Phase 2: Mother-offspring dyad

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of gestational diabetes mellitus
Time Frame: 24-28 weeks of gestation
75g oral glucose tolerance test
24-28 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

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

Investigators

  • Principal Investigator: Marie-France Hivert, MD, MSc, Université de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

June 18, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEN3G

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insulin Resistance

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe