Gestational Diabetes Mellitus and Cardiometabolic Syndrome in Offspring (DG3)

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre de recherche clinique Etienne-Le Bel du CHUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
GDM offspring; Children born from gestational diabetes mellitus pregnancy
No-GDM offspring; Children born from a normal pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic syndrome	Prevalence of metabolic syndrome	4 to 12 years after birth.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory markers	4 to 12 years after birth.	Assessed only once 4 to 12 years after birth

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: November 17, 2011
• First Submitted That Met QC Criteria: December 12, 2011
• First Posted (Estimate): December 13, 2011

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Pregnancy Complications; Diabetes Mellitus; Metabolic Syndrome; Diabetes, Gestational
• Other Study ID Numbers: 10-207