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Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus (SoL)

Primary Purpose

Diabetes, Gestational

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Type 2 diabetes diagnosis test
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes, Gestational

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women aged between 18 and 45 years;
  • Having a positive diagnosis of gestational diabetes mellitus (GDM) (IADPSG or CDA criteria or patient followed for GDM);
  • Treated with diet, insulin or oral hypoglycemic agents;
  • Have given birth to a child at term (gestational age ≥ 37 weeks);
  • Have signed the consent form.

Exclusion Criteria:

  • 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;
    • Had complications during the delivery such as:
  • Moderate to severe postpartum bleeding;
  • Surgery in postpartum (curettage, hysterectomy, etc.).

Sites / Locations

  • Centre de recherche clinique du CHUS

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

Type 2 diabetes diagnosis test.

Outcomes

Primary Outcome Measures

abnormal glucose tolerance

Secondary Outcome Measures

Full Information

First Posted
November 10, 2014
Last Updated
April 29, 2019
Sponsor
Université de Sherbrooke
Collaborators
University of Toronto, University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT02290860
Brief Title
Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus
Acronym
SoL
Official Title
Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus - Stage 2, a Multicentre Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
University of Toronto, University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Gestational diabetes mellitus (GDM) is defined as a hyperglycemia with onset or first recognition during pregnancy. GDM complicates 5 to 25% of pregnancies, depending on the diagnostic criteria used and the population being studied. GDM is an important red flag: up to 70% women with GDM will develop type 2 diabetes mellitus (T2DM) during their lifetime. Accordingly, professional associations recommend T2DM postpartum screening (T2DM-pP-S), 6-to-24 weeks after delivery. A 75g oral glucose tolerance test (OGTT) should be performed for diagnosis (gold standard). Nevertheless, this T2DM-pP-S recommendation has failed worldwide for the same reasons: the presently impractical pattern of the testing. A solution is direly needed. Our overall goal is to improve detection of pre-diabetes and diabetes and more specifically, to facilitate the recommended T2DM-pP-S in women diagnosed with GDM. We hypothesize that, in GDM women, results of an OGTT performed after delivery, before hospital discharge (OGTT-1) predict results of the recommended OGTT at 6-to-12 weeks postpartum (OGTT-2). Our aims are: To validate in Caucasian women the predictive threshold value of the 2hr-glucose of OGTT-1 established by our Stage-1 study. To determine, in a multiethnic non-Caucasian cohort, the threshold value for the 2hr-glucose of OGTT-1 that is predictive of abnormal glucose tolerance at OGTT-2. To define the OGTT time preference of women (before hospital discharge vs. 6-to-12 weeks postpartum). If our results are in line with our Stage-1 data, most redundant 6-to-24 weeks postpartum OGTT will be avoided. Medical practice will change.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
Type 2 diabetes diagnosis test.
Intervention Type
Procedure
Intervention Name(s)
Type 2 diabetes diagnosis test
Intervention Description
Participants will perform type 2 diabetes diagnosis test the day of hospital discharge after delivery and the same test around 8 weeks later.
Primary Outcome Measure Information:
Title
abnormal glucose tolerance
Time Frame
8 weeks after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women aged between 18 and 45 years; Having a positive diagnosis of gestational diabetes mellitus (GDM) (IADPSG or CDA criteria or patient followed for GDM); Treated with diet, insulin or oral hypoglycemic agents; Have given birth to a child at term (gestational age ≥ 37 weeks); Have signed the consent form. Exclusion Criteria: 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; Had complications during the delivery such as: Moderate to severe postpartum bleeding; Surgery in postpartum (curettage, hysterectomy, etc.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc Ardilouze, MD, PhD
Organizational Affiliation
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche clinique du CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

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Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus

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