Glycemic Objectives of Women With Gestational Diabetes Mellitus

NCT02478762 | Terminated Phase 3

• 1 other identifier: 14-160
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

In a previous study, the investigators established the dosage of foetal glycated hemoglobin (FGH). It represents the mean of blood sugar 4-6 before the delivery. The investigators also compared the FGH of newborn of women with and without gestational diabetes mellitus (GDM) and determined that newborn of women with GDM had significantly higher FGH that newborn of women without GDM. In this study, the investigators want to compare the FGH of newborn of GDM women randomized to a group reaching the Canadian Diabetes Association recommended blood glucose objectives treatment (fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L) to a group reaching lower blood glucose objectives (fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L)

Conditions

Gestational Diabetes Mellitus

Keywords

Foetal glycated hemoglobin; Glycemic objectives treatment

Outcome Measures

Primary Outcomes (1)

• Foetal glycated hemoglobin

  At delivery

Secondary Outcomes (1)

• Treatment satisfaction

  End of pregnancy

Study Arms (2)

Normal glycemic control

ACTIVE COMPARATOR

GDM women in this group will reach glycemic objectives recommended by the Canadian Diabetes Association: fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L.

Procedure: Normal glycemic control

Low glycemic control

EXPERIMENTAL

GDM women in this group will reach lower glycemic objectives than those recommended by the Canadian Diabetes Association: fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L.

Procedure: Low glycemic control

Interventions

Normal glycemic control PROCEDURE

Use diet, physical exercise of insulins to reach normal glycemic control.

Normal glycemic control

Low glycemic control PROCEDURE

Use diet, physical exercise of insulins to reach low glycemic control.

Low glycemic control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• gestational age between 15 and 32 weeks since last menstrual date,
• received education on gestational diabetes mellitus,
• able to read and understand French.

You may not qualify if:

• known type 1 or type 2 diabetes,
• treatment interfering woth glucose metabolism,
• deficit may hinder the understanding of the study.

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H5N4, 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

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 23, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

CA (1)