Evaluation and Validation of New Biomarkers by Mass Spectrometry

NCT ID: NCT01025973

Last Updated: 2018-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetes Mellitus

Patients with type 1, type 2 or gestational diabetes mellitus

No interventions assigned to this group

Normal pregnancy

Patient without diabetes mellitus

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Jean-Luc Ardilouze

Endocrinologist, researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Luc Ardilouze, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

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Centre de recherche clinique Etienne-Le Bel du CHUS

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

References

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Dupont FO, Hivert MF, Allard C, Menard J, Perron P, Bouchard L, Robitaille J, Pasquier JC, Auray-Blais C, Ardilouze JL. Glycation of fetal hemoglobin reflects hyperglycemia exposure in utero. Diabetes Care. 2014 Oct;37(10):2830-3. doi: 10.2337/dc14-0549. Epub 2014 Jul 10.

Reference Type DERIVED
PMID: 25011951 (View on PubMed)

Other Identifiers

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09-110

Identifier Type: -

Identifier Source: org_study_id

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