Type 2 DiabetesTot ou tardNCT01869608
Postpartum Screening of Type 2 Diabetes
A study testing oral glucose tolerance test 2 days post-partum in people with Type 2 Diabetes, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Gestational diabetes mellitus (GDM) complicates 5 to 30 % of pregnancies. GDM is defined as hyperglycemia with onset or first recognition during pregnancy. Because it is a forerunner of type 2 diabetes mellitus (T2DM), professional associations recommend T2DM postpartum screening (T2DM-pPS) at 6 weeks/6 months post… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- oral glucose tolerance test 2 days post-partum
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to 31 Dec 2018
- Phase
- Interventional
- 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
Who may be able to join
- Women aged between 18 and 45 years;
- Having a positive diagnosis of gestational diabetes mellitus (IADPSG criteria);
- Treated with diet or insulin;
- Have given birth to a child at term; gestational age > 37 weeks;
- Have been followed during her pregnancy by a physician who delivers in CHUS;
- Have signed the consent form.
Who cannot join
- History of glucose intolerance or diabetes before the pregnancy;
- Have presented another obstetrical pathology during the pregnancy;
- Severe gestational high blood pressure with proteinuria;
- Delayed intrauterine development syndrome;
- Pregnancy with more than a foetus;
- Drug addiction;
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- Had complications during the delivery such as:
- Moderate to severe postpartum bleeding;
- Surgery in postpartum (curettage, hysterectomy, etc.).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Can we Screen Type 2 Diabetes on the 2nd Day After Delivery in Women Who Had Gestational Diabetes Mellitus?
Gestational diabetes mellitus (GDM) complicates 5 to 30 % of pregnancies. GDM is defined as hyperglycemia with onset or first recognition during pregnancy. Because it is a forerunner of type 2 diabetes mellitus (T2DM), professional associations recommend T2DM postpartum screening (T2DM-pPS) at 6 weeks/6 months post delivery, using a 75g oral glucose tolerance test (OGTT).
However, less than a quarter of these women are screened. This recommendation has failed for multiple reasons; the most important being that busy new mothers must deal with the major inconveniences of returning to a sampling center for a 2h testing session, bringing baby along or paying for a sitter, transportation, parking… A mother-friendly solution is direly needed.
Read more
The investigators hypothesize that, in these women, results of an OGTT performed after delivery on the last day of their hospital stay (OGTT-1) will predict results of the recommended OGTT (OGTT-2) at 6 weeks/6 months postpartum.
The main aim of our project is to determine the optimal cut-off value for the 2h glucose result during OGTT-1 in order to predict abnormal glucose tolerance status at OGTT-2 (the gold standard), in the same woman.
- Conditions
- Type 2 Diabetes
- Being tested
- oral glucose tolerance test 2 days post-partum
- Keywords
- postpartum screening, type 2 diabetes
- Medical subject headings
- 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 test 2 days post-partumProcedure or surgery
Screening for type 2 diabetes after gestational diabetes mellitus.
| Study group | Role | What they receive |
|---|---|---|
| postpartum screening | Experimental | Oral glucose tolerance test 2 days post-partum Receives: Procedure: oral glucose tolerance test 2 days post-partum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of abnormal glucose tolerance
Oral glucose tolerance test
Measured: 12 weeks postpartum
Secondary outcomes (1)
Patient's satisfaction
Satisfaction questionnaire
Measured: 12 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 posted5 Jun 2013 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- The Lawson Foundation
- Responsible party
- Principal investigator, Jean-Luc Ardilouze, Université de Sherbrooke
- Investigators
- Jean-Luc Ardilouze, MD, PhD, Principal investigator, Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869608
- Sponsor's protocol ID
- 13-005
- Acronym
- Tot ou tard
- Status last verified
- Apr 2019
- First submitted
- 15 May 2013
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Screen Type 2 Diabetes on the 2nd Day After Delivery in Women Who Had Gestational Diabetes Mellitus?
- ClinicalTrials.gov ID
- NCT01869608
- Acronym / sponsor ID
- Tot ou tard / 13-005
- Conditions
- Type 2 Diabetes
- Keywords
- postpartum screening, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- The Lawson Foundation
- Study start
- Apr 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Jun 2013 (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.
Gestational diabetes mellitus (GDM) complicates 5 to 30 % of pregnancies. GDM is defined as hyperglycemia with onset or first recognition during pregnancy. Because it is a forerunner of type 2 diabetes mellitus (T2DM), professional associations recommend T2DM postpartum screening (T2DM-pPS) at 6 weeks/6 months post delivery, using a 75g oral glucose tolerance test (OGTT).
However, less than a quarter of these women are screened. This recommendation has failed for multiple reasons; the most important being that busy new mothers must deal with the major inconveniences of returning to a sampling center for a 2h testing session, bringing baby along or paying for a sitter, transportation, parking… A mother-friendly solution is direly needed.
The investigators hypothesize that, in these women, results of an OGTT performed after delivery on the last day of their hospital stay (OGTT-1) will predict results of the recommended OGTT (OGTT-2) at 6 weeks/6 months postpartum.
The main aim of our project is to determine the optimal cut-off value for the 2h glucose result during OGTT-1 in order to predict abnormal glucose tolerance status at OGTT-2 (the gold standard), in the same woman.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postpartum screening | Experimental | Procedure: oral glucose tolerance test 2 days post-partumOral glucose tolerance test 2 days post-partum |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged between 18 and 45 years;
- Having a positive diagnosis of gestational diabetes mellitus (IADPSG criteria);
- Treated with diet or insulin;
- Have given birth to a child at term; gestational age > 37 weeks;
- Have been followed during her pregnancy by a physician who delivers in CHUS;
Key exclusion criteria (9 listed)
- History of glucose intolerance or diabetes before the pregnancy;
- Have presented another obstetrical pathology during the pregnancy;
- Moderate to severe postpartum bleeding;
- Surgery in postpartum (curettage, hysterectomy, etc.).
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 test 2 days post-partumScreening for type 2 diabetes after gestational diabetes mellitus. | Procedure or surgery | postpartum screening |
Primary outcome
Diagnosis of abnormal glucose tolerance
Time frame: 12 weeks postpartum
Oral glucose tolerance test
1 secondary outcome
Patient's satisfaction
Time frame: 12 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 1 May 2019.
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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
Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral glucose tolerance test 2 days post-partum in people with 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 6 inclusion and 9 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 1 May 2019. 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?
Diagnosis of abnormal glucose tolerance (time frame: 12 weeks postpartum). 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 1 May 2019.