This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Jean-Luc Ardilouze, Université de Sherbrooke Identifier:
First received: December 3, 2009
Last updated: December 22, 2016
Last verified: December 2016
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.

Diabetes Mellitus

Study Type: Observational
Study Design: 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

Further study details as provided by Jean-Luc Ardilouze, Université de Sherbrooke:

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

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

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

Enrollment: 99
Study Start Date: October 2009
Study Completion Date: February 2013
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Diabetes Mellitus
Patients with type 1, type 2 or gestational diabetes mellitus
Normal pregnancy
Patient without diabetes mellitus


Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01025973

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jean-Luc Ardilouze, Endocrinologist, researcher, Université de Sherbrooke Identifier: NCT01025973     History of Changes
Other Study ID Numbers: 09-110
Study First Received: December 3, 2009
Last Updated: December 22, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on August 18, 2017