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Gestational Diabetes Mellitus and Cardiometabolic Syndrome in Offspring (DG3)

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ClinicalTrials.gov Identifier: NCT01490372
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : December 23, 2016
Eli Lilly and Company
Information provided by (Responsible Party):
Jean-Luc Ardilouze, Université de Sherbrooke

Brief Summary:

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.

Condition or disease
Gestational Diabetes Mellitus

Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Is Gestational Diabetes Mellitus (GDM) an Independent Risk Factor for Cardiometabolic Syndrome in Offspring?
Study Start Date : August 2011
Primary Completion Date : February 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

GDM offspring
Children born from gestational diabetes mellitus pregnancy
No-GDM offspring
Children born from a normal pregnancy

Primary Outcome Measures :
  1. Metabolic syndrome [ Time Frame: 4 to 12 years after birth. ]
    Prevalence of metabolic syndrome

Secondary Outcome Measures :
  1. Inflammatory markers [ Time Frame: Assessed only once 4 to 12 years after birth ]
    4 to 12 years after birth.

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Offspring born from GDM pregnancies and their siblings born to the same mothers but from non-GDM pregnancies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490372

Canada, Quebec
Centre de recherche clinique Étienne-Le Bel du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Eli Lilly and Company
Principal Investigator: Jean-Luc Ardilouze, MD, PhD Université de Sherbrooke

Responsible Party: Jean-Luc Ardilouze, endocrinologist, researcher, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01490372     History of Changes
Other Study ID Numbers: 10-207
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications