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

NCT01623934 | Active Not Recruiting DMC

• 1 other identifier: GEN3G
• Study Type: observational
• Target: 1,034
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes; Insulin Resistance; Obesity Prevention

Keywords

Gestational diabetes; Adiponectin; Leptin; Single Nucleotides Polymorphisms; Insulin resistance; obesity

Outcome Measures

Primary Outcomes (1)

• Diagnosis of gestational diabetes mellitus

  75g oral glucose tolerance test

  24-28 weeks of gestation

Study Arms (2)

Phase 1: Pregnant women

Phase 2: Mother-offspring dyad

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• twin pregnancy

Sponsors & Collaborators

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

Study Sites (1)

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H5N4, Canada

Location

Related Publications (1)

• 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.

  PMID: 26842272 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

maternal and child plasma, whole cord blood, serum/plasma cord blood, maternal and child white cells, placenta, maternal and child urine, child saliva, maternal and child stool, child hair

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance; Obesity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie-France Hivert, MD, MSc

  Harvard Medical School, Harvard Prilgrim Health Care Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, MMSc

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 20, 2012
• Study Start: January 1, 2010
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

CA (1)