Evaluation and Validation of New Biomarkers by Mass Spectrometry (DG7)

May 2, 2018 updated by: Jean-Luc Ardilouze, Université de Sherbrooke

A New Approach by Mass Spectrometry for Evaluation and Validation of New Biomarkers of Fetus and Mother

The investigators will perform biochemical and metabolic evaluations on cord blood, venous blood of the mother and urine of the foetus and mother using time-of-flight and tandem mass spectrometry. The investigators could evaluate, dose and validate gestational diabetes mellitus biomarkers of the fetus and mother.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre de recherche clinique Etienne-Le Bel du CHUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Women with or without diabetes and their newborn.

Description

Inclusion Criteria:

For women:

  • Aged 18 or more
  • 24 weeks of gestation or more
  • Type 1, type 2 or gestational diabetes mellitus for group 1
  • Without diabetes for group 2.

For newborn:

  • 37 weeks of gestation or more
  • Birth weight 2500 g or more

Exclusion Criteria:

  • Multiple birth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Diabetes Mellitus
Patients with type 1, type 2 or gestational diabetes mellitus
Normal pregnancy
Patient without diabetes mellitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Foetal HbA1c
Time Frame: At delivery
At delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Foetal acetylated Hb
Time Frame: At delivery
At delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

December 3, 2009

First Submitted That Met QC Criteria

December 3, 2009

First Posted (Estimate)

December 4, 2009

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 09-110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Clinical Study Report
    Information identifier: Article
    Information comments:

    Glycation of Fetal Hemoglobin Reflects Hyperglycemia Exposure In Utero Felix O. Dupont1, Marie-France Hivert1,2,3, Catherine Allard1, Julie Ménard1, Patrice Perron1,2, Luigi Bouchard1,4,5, Julie Robitaille6, Jean-Charles Pasquier1,7, Christiane Auray-Blais1,8 and Jean-Luc Ardilouze1,2⇑

    + Author Affiliations

    Corresponding author: Jean-Luc Ardilouze, jean-luc.ardilouze@usherbrooke.ca. F.O.D. and M.-F.H. contributed equally to this study.

    Diabetes Care 2014 Oct; 37(10): 2830-2833. https://doi.org/10.2337/dc14-0549

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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