Clinical trial NCT01623934: Role of Adipokines in Glucose Regulation During Pregnancy and in Fetal Development
Official title: Role of Adipokines in Glucose Regulation During Pregnancy and in Fetal Development
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gestational Diabetes
Insulin Resistance
Obesity Prevention
Keywords: Gestational diabetes
Adiponectin
Leptin
Single Nucleotides Polymorphisms
Insulin resistance
obesity
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
name: Canadian Institutes of Health Research (CIHR)
name: American Diabetes Association
name: Diabetes Québec
First posted: 2012-06-20
Enrollment: 1034
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Phase 1: Pregnant women when they come for their first prenatal visit at the Clinique de Prélèvements et de Recherche en Grossesse.

Phase 2: mothers and their child

Brief 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, 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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis of gestational diabetes mellitus
timeFrame: 24-28 weeks of gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Harvard Medical School, Harvard Prilgrim Health Care Institute
name: Marie-France Hivert, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guillemette L, Allard C, Lacroix M, Patenaude J, Battista MC, Doyon M, Moreau J, Menard J, Bouchard L, Ardilouze JL, Perron P, Hivert MF. Genetics of Glucose regulation in Gestation and Growth (Gen3G): a prospective prebirth cohort of mother-child pairs in Sherbrooke, Canada. BMJ Open. 2016 Feb 3;6(2):e010031. doi: 10.1136/bmjopen-2015-010031.