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OpenTrials
Completed

NCT Number: NCT01490372

Gestational Diabetes Mellitus and 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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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de recherche clinique Étienne-Le Bel du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Metabolic syndrome

    Time frame: 4 to 12 years after birth.

    Prevalence of metabolic syndrome

Secondary outcomes

  1. Inflammatory markers

    Time frame: Assessed only once 4 to 12 years after birth

    4 to 12 years after birth.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Is Gestational Diabetes Mellitus (GDM) an Independent Risk Factor for Cardiometabolic Syndrome in Offspring?

Acronym: DG3

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 13, 2011
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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