Clinical trial NCT01340924: Relationship Between Gestational Diabetes and Type 2 Diabetes
Official title: Key Determinants of Type 2 Diabetes Prevention Among Women With a History of Gestational Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Diabetes
Type 2 Diabetes
Keywords: Gestational diabetes
Type 2 diabetes
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In order to avoid selection biases, we plan to recruit 450 women with a history of GDM through administrative data from the Régie de l'assurance maladie du Québec (RAMQ) and children of those mothers.

We plan to recruit 125 women without history of GDM through mail sent to students and employees of local university and children of those mothers.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glucose tolerance assessed using a 75g-Oral Glucose Tolerance Test (OGTT) in mothers
timeFrame: 1 year
Secondary outcomes:
measure: Glycaemic and lipidic profile assessed using a fasting blood sample in children
timeFrame: 1 year
measure: overweight/obesity
timeFrame: 1 year
measure: abdominal obesity
timeFrame: 1 year
measure: metabolic syndrome
timeFrame: 1 year
measure: Breastfeeding
timeFrame: 1 year
measure: Nutrition
timeFrame: 1 year
measure: Physical activity
timeFrame: 1 year
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Laval University, Institute of Nutraceuticals and Functional Foods
Study officials:
affiliation: Laval University
name: Julie Robitaille, R.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kearney M, Perron J, Marc I, Weisnagel SJ, Tchernof A, Robitaille J. Association of prenatal exposure to gestational diabetes with offspring body composition and regional body fat distribution. Clin Obes. 2018 Apr;8(2):81-87. doi: 10.1111/cob.12237. Epub 2017 Dec 13.