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

Insulin Resistance Clinical Trial

— GEN3G  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01623934
• Other study ID #: GEN3G
• Status: Active, not recruiting
• Phase: N/A
• First received: June 18, 2012
• Last updated: May 1, 2017
• Start date: January 2010
• Est. completion date: May 2019

Study information

• Verified date: May 2017
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1086
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Insulin Resistance

Locations

Country	Name	City	State
Canada	Centre de recherche Étienne-Le Bel, Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université de Sherbrooke	Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of gestational diabetes mellitus	75g oral glucose tolerance test	24-28 weeks of gestation