Postpartum Screening of Type 2 Diabetes

NCT01869608 | Completed

• 1 other identifier: 13-005
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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

Keywords

postpartum screening; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Diagnosis of abnormal glucose tolerance

  Oral glucose tolerance test

  12 weeks postpartum

Secondary Outcomes (1)

• Patient's satisfaction

  12 weeks post-partum

Study Arms (1)

postpartum screening

EXPERIMENTAL

Oral glucose tolerance test 2 days post-partum

Procedure: oral glucose tolerance test 2 days post-partum

Interventions

oral glucose tolerance test 2 days post-partum PROCEDURE

Screening for type 2 diabetes after gestational diabetes mellitus.

postpartum screening

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Université de Sherbrooke: lead
• The Lawson Foundation: collaborator

Study Sites (1)

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

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glucose Tolerance Test; Postpartum Period

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Jean-Luc Ardilouze, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor, endocrinologist, researcher

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: June 5, 2013
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 31, 2018
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

CA (1)