NCT01025973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

1.6 years

First QC Date

December 3, 2009

Last Update Submit

May 2, 2018

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Foetal HbA1c

    At delivery

Secondary Outcomes (1)

  • Foetal acetylated Hb

    At delivery

Study Arms (2)

Diabetes Mellitus

Patients with type 1, type 2 or gestational diabetes mellitus

Normal pregnancy

Patient without diabetes mellitus

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with or without diabetes and their newborn.

You may qualify if:

  • For women:
  • Aged 18 or more
  • weeks of gestation or more
  • Type 1, type 2 or gestational diabetes mellitus for group 1
  • Without diabetes for group 2.
  • For newborn:
  • weeks of gestation or more
  • Birth weight 2500 g or more

You may not qualify if:

  • Multiple birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche clinique Etienne-Le Bel du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 25011951DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine, whole blood, cord blood, plasma

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jean-Luc Ardilouze, MD, PhD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Endocrinologist, researcher

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 4, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2011

Study Completion

February 1, 2013

Last Updated

May 8, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)