Gestational Diabetes Mellitus and Cardiometabolic Syndrome in Offspring

NCT ID: NCT01490372

Last Updated: 2018-05-03

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

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-05-31

Brief Summary

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Gestational Diabetes Mellitus (GDM) has long been known as leading to macrosomias, neonatal hypoglycemias and other complications which are treatable and preventable. Nowadays, GDM is recognized as an entity with long-term serious sequels to the mother (GDM is considered a forerunner of type 2 diabetes) and her offspring. Indeed, according to the programming hypothesis, GDM sets the stage for metabolic syndrome, obesity, type 2 diabetes and hypertension. However, these cross-sectional studies failed to control for maternal disease history and genetic background although heredity is a major epidemiology risk factor of type 2 diabetes. Also, studies usually refer to traditional markers such as BMI, blood pressure, lipids profile and oral glucose tolerance test (OGTT); none explored inflammatory biomarkers and adipokines in-depth, despite the possible link between their presence and the development of metabolic and cardiovascular diseases in GDM offsprings.

Exclusion of genetic confounding factors will help establish the role of GDM as an independent marker of cardiometabolic risk in GDM offspring. It is highly relevant to identify GDM as a risk factor for cardiometabolic diseases, given the worldwide obesity epidemic, the alarming prevalence increase of GDM and its serious sequels to both mother and offspring.

Detailed Description

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Conditions

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Gestational Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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GDM offspring

Children born from gestational diabetes mellitus pregnancy

No interventions assigned to this group

No-GDM offspring

Children born from a normal pregnancy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age 4 to 12 years
* Tanner stage \< 2
* to understand French or English

Exclusion Criteria

* Type 1 diabetes
* weight \< 10 kg
* placenta abnormalities
* gestational age \< 34 weeks
* illness affecting growth and metabolism
* taking medications
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Jean-Luc Ardilouze

endocrinologist, researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Luc Ardilouze, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

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Centre de recherche clinique Étienne-Le Bel du CHUS

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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10-207

Identifier Type: -

Identifier Source: org_study_id

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