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Low Grade Inflammation in Type 1 Diabetes Children (Coccinelle)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01099956
First received: March 22, 2010
Last updated: October 24, 2011
Last verified: October 2011
History of Changes
  Purpose

The study propose to measure the inflammation level in type 1 diabetes children with the cytokine analysis compared to non diabetic children of the same sibling and to healthy children.


Condition
Type 1 Diabetes
Inflammation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Low Grade Inflammation in Type 1 Diabetes Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Increase of Interleukine 6 in group DTI versus control group [ Time Frame: Once at inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increase of others cytokines (IL1-beta, l'IL-4, l'IL-10 and TNF alpha) and increase of High sensitivity CRP in group DTI versus control group [ Time Frame: Once at inclusion ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
diabetes group
control group

Detailed Description:

The increase of type 1 diabetes incidence, particularly in young children leads to conduce new diagnostic and therapeutic strategies, notably for associated chronic morbidity.Measurement of chronic inflammation, with modification of the balance between pro-inflammatory cytokines and anti-inflammatory cytokines, could lead to detect patients with high risk to diabetes chronic morbidity.

After parental consent, blood sampling will be carried out by micromethod for cytokine (500 µl) and CRPhs dosages and glycemia (100 µl) and glycated hemoglobin (1 µl). Urine will be collected (50 ml) in the morning for further researches.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

60 children in type 1 diabetes group and 30 children in control group

Criteria

Inclusion Criteria:

Type 1 diabetes children group :

  • Children aged 2 to 17 years
  • Type 1 diabetes children

Controlled group :

  • Children aged 2 to 17 years
  • Brother or sister of type 1 diabetes children

Exclusion Criteria:

  • Per os or inhaled corticoid in the previous month of inclusion
  • Acute infectious disease in the previous week of inclusion
  • Other chronic disease than diabetes type1
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01099956

Locations
France
Children Hospital, Endocrinology Unit
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Pascal BARAT, MD University Hospital, Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01099956     History of Changes
Other Study ID Numbers: CHUBX 2009/28
Study First Received: March 22, 2010
Last Updated: October 24, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
type 1 diabetes
children
low grade inflammation
cytokine
CRP

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Inflammation
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013