Gestational Diabetes MellitusDG4NCT00921882
Is it Possible to Screen for Type 2 Diabetes at Day 2 in Gestational Diabetes Mellitus Patients Postpartum?
An observational study of Gestational Diabetes Mellitus and Type 2 Diabetes, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Within 6 months of delivery, women who had gestational diabetes mellitus should be screened for type 2 diabetes with a fasting plasma glucose test and/or a 2-h postchallenge glycemia in a 75-g oral glucose tolerance test. However, not all women are screened. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus, Type 2 Diabetes
- What is being tested?
- Oral glucose tolerance test
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to May 2013
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with gestational diabetes mellitus who delivered.
Who may be able to join
- Dx of gestational diabetes treated with insulin
- To be in post-partum
- Delivery of a baby of at least 37 weeks of gestation
- Have signed the consent form
Who cannot join
- History of glucose intolerance of diabetes before the pregnancy
- Obstetrical pathology during pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Is it Possible to Screen for Type 2 Diabetes at Day 2 Gestational Diabetes Mellitus Postpartum?
Within 6 months of delivery, women who had gestational diabetes mellitus should be screened for type 2 diabetes with a fasting plasma glucose test and/or a 2-h postchallenge glycemia in a 75-g oral glucose tolerance test. However, not all women are screened. The objective of this study is to compare the screening test for type 2 diabetes done at 48 hours post-partum versus 8 weeks post-partum. The investigators want to measure the specificity, sensitivity, false and true predictive values of the screening test at 48 hours post-partum compared to the gold-standard.
- Conditions
- Gestational Diabetes Mellitus, Type 2 Diabetes
- Being tested
- Oral glucose tolerance test
- Keywords
- Type 2 diabetes, Post-partum screening
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testProcedure or surgery
Subjects will have the Oral glucose tolerance test 48 hours post-partum and the same test 8 weeks post-partum.
| Study group | Role | What they receive |
|---|---|---|
| Oral glucose tolerance test | oral glucose tolerance test performed 48 hours post-partum and 8 weeks post-partum. Receives: Procedure: Oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral glucose tolerance test
Sensitivity, specificity, true and false predictive values of the oral glucose tolerance test
Measured: 8 weeks post partum
Secondary outcomes (1)
Acceptability of screening test
Prefered moment to do the screening test (48 hours post partum or 8 weeks post partum)
Measured: 8 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startJun 2008
- Primary completionOct 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Luc Ardilouze, Université de Sherbrooke
- Investigators
- Jean-Luc Ardilouze, MD, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921882
- Sponsor's protocol ID
- 07-084
- Acronym
- DG4
- Status last verified
- May 2018
- First submitted
- 10 Jun 2009
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Possible to Screen for Type 2 Diabetes at Day 2 Gestational Diabetes Mellitus Postpartum?
- ClinicalTrials.gov ID
- NCT00921882
- Acronym / sponsor ID
- DG4 / 07-084
- Conditions
- Gestational Diabetes Mellitus, Type 2 Diabetes
- Keywords
- Type 2 diabetes, Post-partum screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jun 2008 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 16 Jun 2009 (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.
Within 6 months of delivery, women who had gestational diabetes mellitus should be screened for type 2 diabetes with a fasting plasma glucose test and/or a 2-h postchallenge glycemia in a 75-g oral glucose tolerance test. However, not all women are screened. The objective of this study is to compare the screening test for type 2 diabetes done at 48 hours post-partum versus 8 weeks post-partum. The investigators want to measure the specificity, sensitivity, false and true predictive values of the screening test at 48 hours post-partum compared to the gold-standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral glucose tolerance test | – | Procedure: Oral glucose tolerance testoral glucose tolerance test performed 48 hours post-partum and 8 weeks post-partum. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with gestational diabetes mellitus who delivered.
Key inclusion criteria (4 listed)
- Dx of gestational diabetes treated with insulin
- To be in post-partum
- Delivery of a baby of at least 37 weeks of gestation
- Have signed the consent form
Key exclusion criteria (2 listed)
- History of glucose intolerance of diabetes before the pregnancy
- Obstetrical pathology during pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral glucose tolerance testSubjects will have the Oral glucose tolerance test 48 hours post-partum and the same test 8 weeks post-partum. | Procedure or surgery | Oral glucose tolerance test |
Primary outcome
Oral glucose tolerance test
Time frame: 8 weeks post partum
Sensitivity, specificity, true and false predictive values of the oral glucose tolerance test
1 secondary outcome
Acceptability of screening test
Time frame: 8 weeks post partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
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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.
Jean-Luc Ardilouze, MD, PhD principal investigator
Université de Sherbrooke
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 Mellitus and Type 2 Diabetes, run by Université de Sherbrooke 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 3 May 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oral glucose tolerance test (time frame: 8 weeks post partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2018.