Gestational Diabetes Mellitus and Cardiometabolic Syndrome in Offspring

Gestational Diabetes Mellitus Clinical Trial

— DG3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490372
• Other study ID #: 10-207
• Status: Completed
• Start date: August 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2018
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Locations

Country	Name	City	State
Canada	Centre de recherche clinique Étienne-Le Bel du CHUS	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Eli Lilly and Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic syndrome	Prevalence of metabolic syndrome	4 to 12 years after birth.
Secondary	Inflammatory markers	4 to 12 years after birth.	Assessed only once 4 to 12 years after birth