Evaluation and Validation of New Biomarkers by Mass Spect... | NCT01025973

Studies
Evaluation and Validation of New Biomarkers by Mass Spectrometry

NCT01025973

Sponsor

Université de Sherbrooke

Status

Completed

Last Update Posted

May 8, 2018Actual

Enrollment

99Actual

Phase

Not provided

Conditions

Diabetes Mellitus

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

May 2011Actual

Completion Date

Feb 2013Actual

First Submitted Date

Dec 3, 2009

First Submission Date that Met QC Criteria

Dec 3, 2009

First Posted Date

Dec 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2018

Last Update Posted Date

May 8, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jean-Luc Ardilouze, Endocrinologist, researcher, Université de SherbrookePrincipal Investigator

Lead Sponsor

Université de SherbrookeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

99Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetes Mellitus		Patients with type 1, type 2 or gestational diabetes mellitus
Normal pregnancy		Patient without diabetes mellitus

Interventions

Not provided

Measure	Description	Time Frame
Foetal HbA1c		At delivery

Measure	Description	Time Frame
Foetal acetylated Hb		At delivery

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Women with or without diabetes and their newborn.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Luc Ardilouze, MD, PhD	Université de Sherbrooke	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre de recherche clinique Etienne-Le Bel du CHUS		Sherbrooke	Quebec	J1H 5N4	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25011951	Derived	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.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases