Gestational Diabetes Mellitus Clinical Trial
— DG3Official title:
Is Gestational Diabetes Mellitus (GDM) an Independent Risk Factor for Cardiometabolic Syndrome in Offspring?
NCT number | NCT01490372 |
Other study ID # | 10-207 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2011 |
Est. completion date | May 2013 |
Verified date | May 2018 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre de recherche clinique Étienne-Le Bel du CHUS | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke | Eli Lilly and Company |
Canada,
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 |
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