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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01025973
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : May 8, 2018
Information provided by (Responsible Party):
Jean-Luc Ardilouze, Université de Sherbrooke

Brief Summary:
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.

Condition or disease
Diabetes Mellitus

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Study Type : Observational
Actual Enrollment : 99 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A New Approach by Mass Spectrometry for Evaluation and Validation of New Biomarkers of Fetus and Mother
Study Start Date : October 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : February 2013

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

Primary Outcome Measures :
  1. Foetal HbA1c [ Time Frame: At delivery ]

Secondary Outcome Measures :
  1. Foetal acetylated Hb [ Time Frame: At delivery ]

Biospecimen Retention:   Samples Without DNA
Urine, whole blood, cord blood, plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with or without diabetes and their newborn.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01025973

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Canada, Quebec
Centre de recherche clinique Etienne-Le Bel du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
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Principal Investigator: Jean-Luc Ardilouze, MD, PhD Université de Sherbrooke

Study Data/Documents: Clinical Study Report  This link exits the site
Identifier: Article

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, F.O.D. and M.-F.H. contributed equally to this study.

Diabetes Care 2014 Oct; 37(10): 2830-2833.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jean-Luc Ardilouze, Endocrinologist, researcher, Université de Sherbrooke Identifier: NCT01025973     History of Changes
Other Study ID Numbers: 09-110
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No