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Completed

NCT Number: NCT01099956

Low Grade Inflammation in Type 1 Diabetes Children

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children Hospital, Endocrinology Unit

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Increase of Interleukine 6 in group DTI versus control group

    Time frame: Once at inclusion

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: Coccinelle

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 8, 2010
Registry last updated
Oct 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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