Original Query: diabetes
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Relationship Between Gestational Diabetes and Type 2 Diabetes (GDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01340924
Recruitment Status : Active, not recruiting
First Posted : April 25, 2011
Last Update Posted : February 14, 2017
Information provided by (Responsible Party):
Julie Robitaille, Laval University

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.

Condition or disease
Gestational Diabetes Type 2 Diabetes

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.

Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Key Determinants of Type 2 Diabetes Prevention Among Women With a History of Gestational Diabetes Mellitus
Study Start Date : September 2009
Primary Completion Date : September 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Glucose tolerance assessed using a 75g-Oral Glucose Tolerance Test (OGTT) in mothers [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Glycaemic and lipidic profile assessed using a fasting blood sample in children [ Time Frame: 1 year ]
  2. overweight/obesity [ Time Frame: 1 year ]
    In mothers and children

  3. abdominal obesity [ Time Frame: 1 year ]
    In mothers and children

  4. metabolic syndrome [ Time Frame: 1 year ]
    In mothers and children

  5. Breastfeeding [ Time Frame: 1 year ]
    In mothers and children

  6. Nutrition [ Time Frame: 1 year ]
    In mothers and children

  7. Physical activity [ Time Frame: 1 year ]
    In mothers and children

Biospecimen Retention:   Samples With DNA
whole blood; serum; white cell.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01340924

Laval University, Institute of Nutraceuticals and Functional Foods
Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Principal Investigator: Julie Robitaille, R.D., Ph.D. Laval University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Julie Robitaille, Assistant Professor, Laval University Identifier: NCT01340924     History of Changes
Other Study ID Numbers: GDM
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Julie Robitaille, Laval University:
Gestational diabetes
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications