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
  Purpose

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
Gestational Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Is Gestational Diabetes Mellitus (GDM) an Independent Risk Factor for Cardiometabolic Syndrome in Offspring?

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Metabolic syndrome [ Time Frame: 4 to 12 years after birth. ] [ Designated as safety issue: No ]
    Prevalence of metabolic syndrome


Secondary Outcome Measures:
  • Inflammatory markers [ Time Frame: Assessed only once 4 to 12 years after birth ] [ Designated as safety issue: No ]
    4 to 12 years after birth.


Enrollment: 41
Study Start Date: August 2011
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
GDM offspring
Children born from gestational diabetes mellitus pregnancy
No-GDM offspring
Children born from a normal pregnancy

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490372

Locations
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
Investigators
Principal Investigator: Jean-Luc Ardilouze, MD, PhD Université de Sherbrooke
  More Information

No publications provided

Responsible Party: Jean-Luc Ardilouze, endocrinologist, researcher, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01490372     History of Changes
Other Study ID Numbers: 10-207
Study First Received: November 17, 2011
Last Updated: May 14, 2013
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on July 10, 2014