Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Low Grade Inflammation in Type 1 Diabetes Children (Coccinelle)

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Bordeaux Identifier:
First received: March 22, 2010
Last updated: October 24, 2011
Last verified: October 2011
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.

Type 1 Diabetes

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:

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 ]

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 ]

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)
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.


Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
60 children in type 1 diabetes group and 30 children in control group

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01099956

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

Responsible Party: University Hospital, Bordeaux Identifier: NCT01099956     History of Changes
Other Study ID Numbers: CHUBX 2009/28
Study First Received: March 22, 2010
Last Updated: October 24, 2011

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes processed this record on May 25, 2017