Gestational Diabetes Mellitus and Cardiometabolic Syndrome in Offspring (DG3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01490372
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : May 3, 2018
Eli Lilly and Company
Information provided by (Responsible Party):
Jean-Luc Ardilouze, Université de Sherbrooke

November 17, 2011
December 13, 2011
May 3, 2018
August 2011
February 2013   (Final data collection date for primary outcome measure)
Metabolic syndrome [ Time Frame: 4 to 12 years after birth. ]
Prevalence of metabolic syndrome
Same as current
Complete list of historical versions of study NCT01490372 on Archive Site
Inflammatory markers [ Time Frame: Assessed only once 4 to 12 years after birth ]
4 to 12 years after birth.
Same as current
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Gestational Diabetes Mellitus and Cardiometabolic Syndrome in Offspring
Is Gestational Diabetes Mellitus (GDM) an Independent Risk Factor for Cardiometabolic Syndrome in Offspring?

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.

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Observational Model: Case-Control
Time Perspective: Cross-Sectional
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Non-Probability Sample
Offspring born from GDM pregnancies and their siblings born to the same mothers but from non-GDM pregnancies.
Gestational Diabetes Mellitus
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  • GDM offspring
    Children born from gestational diabetes mellitus pregnancy
  • No-GDM offspring
    Children born from a normal pregnancy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
4 Years to 12 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
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Jean-Luc Ardilouze, Université de Sherbrooke
Université de Sherbrooke
Eli Lilly and Company
Principal Investigator: Jean-Luc Ardilouze, MD, PhD Université de Sherbrooke
Université de Sherbrooke
May 2018