Gestational Diabetes Mellitus and Cardiometabolic Syndrome in Offspring

Completed

• Conditions: Gestational Diabetes Mellitus

• Registration Number: NCT01490372
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-13
• Primary Completion: 2013-02
• Study Completion: 2013-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolic syndrome	4 to 12 years after birth.	Prevalence of metabolic syndrome

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers	Assessed only once 4 to 12 years after birth	4 to 12 years after birth.

Trial Locations

Locations (1)

Centre de recherche clinique Étienne-Le Bel du CHUS; 🇨🇦 Sherbrooke, Quebec, Canada