Gestational DiabetesGDMNCT01340924
Relationship Between Gestational Diabetes and Type 2 Diabetes
An observational study of Gestational Diabetes and Type 2 Diabetes, run by Laval University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Type 2 Diabetes
- How many people
- 450 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Women aged ≥18 years with or without a diagnosis of GDM in the past 3-12 years and their children.
Who cannot join
- Pregnant women, women with type 1 diabetes.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Laval University, Institute of Nutraceuticals and Functional Foods
Québec, G1V 0A6
About this study
Official title: 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.
Read the 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.
- Conditions
- Gestational Diabetes, Type 2 Diabetes
- Keywords
- Gestational diabetes, Type 2 diabetes
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance assessed using a 75g-Oral Glucose Tolerance Test (OGTT) in mothers
Measured: 1 year
Secondary outcomes (7)
Glycaemic and lipidic profile assessed using a fasting blood sample in children
Measured: 1 year
overweight/obesity
In mothers and children
Measured: 1 year
abdominal obesity
In mothers and children
Measured: 1 year
metabolic syndrome
In mothers and children
Measured: 1 year
Breastfeeding
In mothers and children
Measured: 1 year
Nutrition
In mothers and children
Measured: 1 year
Physical activity
In mothers and children
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startSep 2009
- Primary completionSep 2016
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Robitaille, Laval University
- Investigators
- Julie Robitaille, R.D., Ph.D., Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340924
- Sponsor's protocol ID
- GDM
- Acronym
- GDM
- Status last verified
- Apr 2022
- First submitted
- 15 Mar 2011
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Kearney M, Perron J, Marc I, Weisnagel SJ, Tchernof A, Robitaille J. Association of prenatal exposure to gestational diabetes with offspring body composition and regional body fat distribution. Clin Obes. 2018 Apr;8(2):81-87. doi: 10.1111/cob.12237. Epub 2017 Dec 13.
PubMed 29239129
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Key Determinants of Type 2 Diabetes Prevention Among Women With a History of Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01340924
- Acronym / sponsor ID
- GDM / GDM
- Conditions
- Gestational Diabetes, Type 2 Diabetes
- Keywords
- Gestational diabetes, Type 2 diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Women aged ≥18 years with or without a diagnosis of GDM in the past 3-12 years and their children.
Key exclusion criteria (1 listed)
- Pregnant women, women with type 1 diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glucose tolerance assessed using a 75g-Oral Glucose Tolerance Test (OGTT) in mothers
Time frame: 1 year
7 secondary outcomes
Glycaemic and lipidic profile assessed using a fasting blood sample in children
Time frame: 1 year
overweight/obesity
Time frame: 1 year
abdominal obesity
Time frame: 1 year
metabolic syndrome
Time frame: 1 year
Breastfeeding
Time frame: 1 year
Nutrition
Time frame: 1 year
Physical activity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Derived from this study: PubMed 29239129Kearney M, Perron J, Marc I, Weisnagel SJ, Tchernof A, Robitaille J. Association of prenatal exposure to gestational diabetes with offspring body composition and regional body fat distribution. Clin Obes. 2018 Apr;8(2):81-87. doi: 10.1111/cob.12237. Epub 2017 Dec 13.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Robitaille, R.D., Ph.D. principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Type 2 Diabetes, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose tolerance assessed using a 75g-Oral Glucose Tolerance Test (OGTT) in mothers (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01340924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.