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Relationship Between Gestational Diabetes and Type 2 Diabetes (GDM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Julie Robitaille, Laval University
ClinicalTrials.gov Identifier:
NCT01340924
First received: March 15, 2011
Last updated: February 13, 2017
Last verified: February 2017
  Purpose
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
Gestational Diabetes Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Key Determinants of Type 2 Diabetes Prevention Among Women With a History of Gestational Diabetes Mellitus

Further study details as provided by Julie Robitaille, Laval University:

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

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

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

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

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

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

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


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

Estimated Enrollment: 450
Study Start Date: September 2009
Estimated Study Completion Date: December 2017
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
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

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340924

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

Responsible Party: Julie Robitaille, Assistant Professor, Laval University
ClinicalTrials.gov Identifier: NCT01340924     History of Changes
Other Study ID Numbers: GDM
Study First Received: March 15, 2011
Last Updated: February 13, 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

ClinicalTrials.gov processed this record on August 18, 2017