Is it Possible to Screen for Type 2 Diabetes at Day 2 in Gestational Diabetes Mellitus Patients Postpartum?

NCT00921882 | Completed

• 1 other identifier: 07-084
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Type 2 diabetes; Post-partum screening

Outcome Measures

Primary Outcomes (1)

• Oral glucose tolerance test

  Sensitivity, specificity, true and false predictive values of the oral glucose tolerance test

  8 weeks post partum

Secondary Outcomes (1)

• Acceptability of screening test

  8 weeks post partum

Study Arms (1)

Oral glucose tolerance test

oral glucose tolerance test performed 48 hours post-partum and 8 weeks post-partum.

Procedure: Oral glucose tolerance test

Interventions

Oral glucose tolerance test PROCEDURE

Subjects will have the Oral glucose tolerance test 48 hours post-partum and the same test 8 weeks post-partum.

Oral glucose tolerance test

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with gestational diabetes mellitus who delivered.

You may qualify if:

• 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

You may not qualify if:

• History of glucose intolerance of diabetes before the pregnancy
• Obstetrical pathology during pregnancy

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; 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

Study Officials

• Jean-Luc Ardilouze, MD, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist, researcher

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 16, 2009
• Study Start: June 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: May 1, 2013
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

CA (1)