Relationship Between Gestational Diabetes and Type 2 Diabetes (GDM)

April 7, 2022 updated by: Julie Robitaille, Laval University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 0A6
        • Laval University, Institute of Nutraceuticals and Functional Foods

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose tolerance assessed using a 75g-Oral Glucose Tolerance Test (OGTT) in mothers
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycaemic and lipidic profile assessed using a fasting blood sample in children
Time Frame: 1 year
1 year
overweight/obesity
Time Frame: 1 year
In mothers and children
1 year
abdominal obesity
Time Frame: 1 year
In mothers and children
1 year
metabolic syndrome
Time Frame: 1 year
In mothers and children
1 year
Breastfeeding
Time Frame: 1 year
In mothers and children
1 year
Nutrition
Time Frame: 1 year
In mothers and children
1 year
Physical activity
Time Frame: 1 year
In mothers and children
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Julie Robitaille, R.D., Ph.D., Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2016

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 15, 2011

First Submitted That Met QC Criteria

April 21, 2011

First Posted (Estimate)

April 25, 2011

Study Record Updates

Last Update Posted (Actual)

April 8, 2022

Last Update Submitted That Met QC Criteria

April 7, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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