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

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ClinicalTrials.gov Identifier: NCT01025973
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : December 23, 2016
Information provided by (Responsible Party):

Study Description
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

Study Design

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
Primary Completion Date : May 2011
Study Completion Date : February 2013
Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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

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 ClinicalTrials.gov identifier (NCT number): 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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean-Luc Ardilouze, Endocrinologist, researcher, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01025973     History of Changes
Other Study ID Numbers: 09-110
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 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