Evaluation and Validation of New Biomarkers by Mass Spectrometry

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01025973

Acronym

DG7

Enrollment

Registered

2009-12-04

Start date

2009-10-31

Completion date

2013-02-28

Last updated

2018-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Foetal HbA1c	At delivery

Secondary

Measure	Time frame
Foetal acetylated Hb	At delivery

Countries

Canada

Outcome results