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

NCT02290860 | Completed

• 1 other identifier: 14-161
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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:

1. 1.To validate in Caucasian women the predictive threshold value of the 2hr-glucose of OGTT-1 established by our Stage-1 study.
2. 2.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.
3. 3.To define the OGTT time preference of women (before hospital discharge vs. 6-to-12 weeks postpartum).

Conditions

Diabetes, Gestational

Outcome Measures

Primary Outcomes (1)

• abnormal glucose tolerance

  8 weeks after delivery

Study Arms (1)

Intervention

OTHER

Type 2 diabetes diagnosis test.

Procedure: Type 2 diabetes diagnosis test

Interventions

Type 2 diabetes diagnosis test PROCEDURE

Participants will perform type 2 diabetes diagnosis test the day of hospital discharge after delivery and the same test around 8 weeks later.

Intervention

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 (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.

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
• University of Toronto: collaborator
• University of Manitoba: collaborator

Study Sites (1)

Centre de recherche clinique du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Diabetes, Gestational

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

Study Officials

• Jean-Luc Ardilouze, MD, PhD

  Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  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: Endocrinologist, researcher

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 14, 2014
• Study Start: December 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

CA (1)