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Clinical Trials/NCT01340924
NCT01340924
Unknown
Not Applicable

Key Determinants of Type 2 Diabetes Prevention Among Women With a History of Gestational Diabetes Mellitus

Laval University1 site in 1 country450 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Diabetes
Sponsor
Laval University
Enrollment
450
Locations
1
Primary Endpoint
Glucose tolerance assessed using a 75g-Oral Glucose Tolerance Test (OGTT) in mothers
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
December 2023
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julie Robitaille

Assistant Professor

Laval University

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.

Outcomes

Primary Outcomes

Glucose tolerance assessed using a 75g-Oral Glucose Tolerance Test (OGTT) in mothers

Time Frame: 1 year

Secondary Outcomes

  • abdominal obesity(1 year)
  • Physical activity(1 year)
  • metabolic syndrome(1 year)
  • Breastfeeding(1 year)
  • Glycaemic and lipidic profile assessed using a fasting blood sample in children(1 year)
  • overweight/obesity(1 year)
  • Nutrition(1 year)

Study Sites (1)

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