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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jean-Luc Ardilouze, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01025973
First received: December 3, 2009
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Foetal HbA1c [ Time Frame: At delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Foetal acetylated Hb [ Time Frame: At delivery ] [ Designated as safety issue: No ]

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women with or without diabetes and their newborn.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025973

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

No publications provided

Responsible Party: Jean-Luc Ardilouze, Endocrinologist, researcher, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01025973     History of Changes
Other Study ID Numbers: 09-110
Study First Received: December 3, 2009
Last Updated: May 14, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 22, 2014