Postpartum Screening of Type 2 Diabetes

NCT ID: NCT01869608

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-12-31

Brief 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 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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

postpartum screening

Oral glucose tolerance test 2 days post-partum

Group Type: EXPERIMENTAL

oral glucose tolerance test 2 days post-partum

Intervention Type: PROCEDURE

Screening for type 2 diabetes after gestational diabetes mellitus.

Interventions

oral glucose tolerance test 2 days post-partum

Screening for type 2 diabetes after gestational diabetes mellitus.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Lawson Foundation

OTHER

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Jean-Luc Ardilouze

Full professor, endocrinologist, researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Luc Ardilouze, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital

Locations

Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

13-005

Identifier Type: -

Identifier Source: org_study_id