This trial is active, not recruiting.

Conditions gestational diabetes, type 2 diabetes
Sponsor Laval University
Start date September 2009
End date September 2016
Trial size 450 participants
Trial identifier NCT01340924, GDM


The overall objective of this research project is to study the impact of preventive practices on the T2D-related risk profile among women with and without prior GDM and their children exposed and unexposed to GDM.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Glucose tolerance assessed using a 75g-Oral Glucose Tolerance Test (OGTT) in mothers
time frame: 1 year

Secondary Outcomes

Glycaemic and lipidic profile assessed using a fasting blood sample in children
time frame: 1 year
time frame: 1 year
abdominal obesity
time frame: 1 year
metabolic syndrome
time frame: 1 year
time frame: 1 year
time frame: 1 year
Physical activity
time frame: 1 year

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Women aged ≥18 years with or without a diagnosis of GDM in the past 3-12 years and their children. Exclusion Criteria: - Pregnant women, women with type 1 diabetes.

Additional Information

Official title Key Determinants of Type 2 Diabetes Prevention Among Women With a History of Gestational Diabetes Mellitus
Principal investigator Julie Robitaille, R.D., Ph.D.
Description Type 2 diabetes (T2D) is a growing public health problem owing to its prevalence as well as its high morbidity and mortality rates. The identification of high-risk populations is of great importance particularly because the onset of T2D can be prevented or delayed by lifestyle modifications. Among high-risk populations, women with previously diagnosed gestational diabetes mellitus (GDM) are at particularly high risk of developing T2D. The success in reducing the occurrence of T2D among women with previous GDM could be achieved only if appropriate preventive measures are undertaken. According to the American Diabetes Association (ADA) and the Canadian Diabetes Association (CDA), lifestyle modifications aimed at reducing body weight and increasing physical activity are recommended and women are encouraged to be breastfeeding their infants. Certain factors have been suggested as determinants of behavioral practices in women with prior GDM including cognitive and environmental factors. A better understanding of these issues is essential for developing effective preventive strategies and possibly reducing the prevalence of T2D in the population. Moreover, in utero exposure to maternal impaired glucose tolerance or diabetes may increase the risk of developing overweight or diabetes in offspring. Since March 2012 we thus test the presence of childhood metabolic alterations predictive of future T2D in GDM-exposed and unexposed offspring and investigate environmental factors during the postnatal period that are associated with prevention of metabolic alterations.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Laval University.