Relationship Between Gestational Diabetes and Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— GDM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01340924
• Other study ID #: GDM
• Status: Active, not recruiting
• Start date: September 2009
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: December 2023
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes
• Type 2 Diabetes

Locations

Country	Name	City	State
Canada	Laval University, Institute of Nutraceuticals and Functional Foods	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose tolerance assessed using a 75g-Oral Glucose Tolerance Test (OGTT) in mothers		1 year
Secondary	Glycaemic and lipidic profile assessed using a fasting blood sample in children		1 year
Secondary	overweight/obesity	In mothers and children	1 year
Secondary	abdominal obesity	In mothers and children	1 year
Secondary	metabolic syndrome	In mothers and children	1 year
Secondary	Breastfeeding	In mothers and children	1 year
Secondary	Nutrition	In mothers and children	1 year
Secondary	Physical activity	In mothers and children	1 year