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

NCT ID: NCT01623934

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1034 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gestational Diabetes Insulin Resistance Obesity Prevention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Phase 1: Pregnant women

No interventions assigned to this group

Phase 2: Mother-offspring dyad

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

American Diabetes Association

OTHER

Sponsor Role collaborator

Diabetes Québec

OTHER

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Marie-France Hivert

Md, MMSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie-France Hivert, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School, Harvard Prilgrim Health Care Institute

Locations

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Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 26842272 (View on PubMed)

Other Identifiers

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GEN3G

Identifier Type: -

Identifier Source: org_study_id

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