Trial document




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  DRKS00007397

Trial Description

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Title

IL-7 and IL-2 dependent T cell response in pediatric type 1 diabetes

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

In this study, the influence of IL-7 or IL-2 costimulation on T cell activation in children with type 1 diabetes and the expression of membrane-bound IL-7 receptor on T-cell subpopulations and the soluble IL-7 or IL-2 receptor in serum of children with type 1 diabetes should be analyzed. Additionally microRNAs in serum and in PBMCs (peripheral blood mononuclear cells) of these patients should be analysed.
In a functional in vitro assay the T cell response dependent on recombinant IL-7 and IL-2 is to be characterized. This functional in vitro assay as well as the determination of IL-7 / IL-2 receptor expression and secretion should be investigated in children with type 1 diabetes at different stages of disease as well as at first manifestation and late stages of disease. In another approach, the association of the rs6897932 polymorphism in the IL-7 receptor (CD127) and IL-2R polymorphisms with type 1 diabetes should be tested in the present DNA samples.

The immunological data will be correlated with the clinical data from the DPV system (diabetes patients progress documentation), the antibody status of the subjects, and the HLA type.

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Organizational Data

  •   DRKS00007397
  •   2014/11/11
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  •   yes
  •   Approved
  •   4608, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   E10 -  Insulin-dependent diabetes mellitus
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Interventions/Observational Groups

  •   Determination of T cell response (FACS analysis) in patients with diabetes manifestation and age of manifestation below 5 years. Correlation of the results with data from the patient's health record and with metabolic parameters.

  •   Determination of T cell response (FACS analysis) in patients with diabetes manifestation and age of manifestation above 5 years. Correlation of the results with data from the patient's health record and with metabolic parameters.

  •   Determination of T cell response (FACS analysis) in patients with diabetes duration of one or more years; age 5 to 18. Correlation of the results with data from the patient's health record and with metabolic parameters.
  •   Determination of T cell response (FACS analysis) in patients without diabetes; age 5 to 18. Correlation of the results with data from the patient's health record and with metabolic parameters.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Differences in the T cell response depending on age at manifestation, duration of diabetes, metabolic parameters.

What: T cell response, isolation of micro RNA, data from the patient's health record, metabolic parameters

When: one study appointment (arm 3 and 4), two study appointments (arm 1 and 2); second visit 6 to 12 weeks after first visit

How: Flow cytometry

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Secondary Outcome

Differences in the T cell response depending on clinical parameters.

What: T cell response, isolation of micro RNA, data from the patient's health record, metabolic parameters

When: one study appointment (arm 3 and 4), two study appointments (arm 1 and 2)

How: Flow cytometry

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/11/20
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   18   Years
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Additional Inclusion Criteria

type 1 diabetes; at manifestation or with diabetes duration of at least one year; age 0-18

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Exclusion Criteria

acute infection

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Addresses

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    • Universitätklinikum Düsseldorf Klinik für Allgemeine Pädiatrie, Kinderkardiologie und Neonatologie
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätklinikum Düsseldorf, Klinik für Allgemeine Pädiatrie, Kinderkardiologie und Neonatologie
    • Ms.  Katharina  Förtsch 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätklinikum Düsseldorf, Klinik für Allgemeine Pädiatrie, Kinderkardiologie und Neonatologie
    • Ms.  Katharina  Förtsch 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Universitätklinikum Düsseldorf Klinik für Allgemeine Pädiatrie, Kinderkardiologie und Neonatologie
    • 40225  Düsseldorf
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.