Evaluation and Validation of New Biomarkers by Mass Spectrometry

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT01025973
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-12-03
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-04
• Primary Completion: 2011-05
• Study Completion: 2013-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Foetal HbA1c	At delivery

Secondary Outcome Measures

Name	Time	Method
Foetal acetylated Hb	At delivery

Trial Locations

Locations (1)

Centre de recherche clinique Etienne-Le Bel du CHUS; 🇨🇦 Sherbrooke, Quebec, Canada