Glycemic Objectives of Women With Gestational Diabetes Mellitus

NCT ID: NCT02478762

Last Updated: 2018-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gestational Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal glycemic control

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.

Group Type ACTIVE_COMPARATOR

Normal glycemic control

Intervention Type PROCEDURE

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

Low glycemic control

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.

Group Type EXPERIMENTAL

Low glycemic control

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Normal glycemic control

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

Intervention Type PROCEDURE

Low glycemic control

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jean-Luc Ardilouze

Endocrinologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-Luc Ardilouze, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14-160

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study to Prevent Dysglycemia in Women With GDM
NCT07269405 ENROLLING_BY_INVITATION NA