Gestational Diabetes Mellitus and Cardiometabolic Syndrome in Offspring

NCT01490372 | Completed

• 1 other identifier: 10-207
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Metabolic syndrome

  Prevalence of metabolic syndrome

  4 to 12 years after birth.

Secondary Outcomes (1)

• Inflammatory markers

  Assessed only once 4 to 12 years after birth

Study Arms (2)

GDM offspring

Children born from gestational diabetes mellitus pregnancy

No-GDM offspring

Children born from a normal pregnancy

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• age 4 to 12 years
• Tanner stage \< 2
• to understand French or English

You may not qualify if:

• Type 1 diabetes
• weight \< 10 kg
• placenta abnormalities
• gestational age \< 34 weeks
• illness affecting growth and metabolism
• taking medications

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Centre de recherche clinique Étienne-Le Bel du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jean-Luc Ardilouze, MD, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: endocrinologist, researcher

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: December 13, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

CA (1)