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
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 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 September 18, 2014