Evaluation and Validation of New Biomarkers by Mass Spectrometry

Diabetes Mellitus Clinical Trial

— DG7  

Official title:

A New Approach by Mass Spectrometry for Evaluation and Validation of New Biomarkers of Fetus and Mother

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025973
• Other study ID #: 09-110
• Status: Completed
• Start date: October 2009
• Est. completion date: February 2013

Study information

• Verified date: May 2018
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 2013
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Locations

Country	Name	City	State
Canada	Centre de recherche clinique Etienne-Le Bel du CHUS	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foetal HbA1c		At delivery
Secondary	Foetal acetylated Hb		At delivery