Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Gestational Diabetes Mellitus and Cardiometabolic Syndrome in Offspring (DG3)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Jean-Luc Ardilouze, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01490372
First received: November 17, 2011
Last updated: May 14, 2013
Last verified: May 2013

November 17, 2011
May 14, 2013
August 2011
February 2013   (final data collection date for primary outcome measure)
Metabolic syndrome [ Time Frame: 4 to 12 years after birth. ] [ Designated as safety issue: No ]
Prevalence of metabolic syndrome
Same as current
Complete list of historical versions of study NCT01490372 on ClinicalTrials.gov Archive Site
Inflammatory markers [ Time Frame: Assessed only once 4 to 12 years after birth ] [ Designated as safety issue: No ]
4 to 12 years after birth.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Offspring born from GDM pregnancies and their siblings born to the same mothers but from non-GDM pregnancies.

Gestational Diabetes Mellitus
Not Provided
  • GDM offspring
    Children born from gestational diabetes mellitus pregnancy
  • No-GDM offspring
    Children born from a normal pregnancy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
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
Both
4 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01490372
10-207
No
Jean-Luc Ardilouze, Universitaire de Sherbrooke
Université de Sherbrooke
Eli Lilly and Company
Principal Investigator: Jean-Luc Ardilouze, MD, PhD Université de Sherbrooke
Université de Sherbrooke
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP