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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00007397 |
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Date of registration:
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11/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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IL-7 and IL-2 dependent T cell response in pediatric type 1 diabetes
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Scientific title:
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IL-7 and IL-2 dependent T cell response in pediatric type 1 diabetes |
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Date of first enrolment:
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20/11/2014 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00007397 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: basic science
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Katharina
Förtsch |
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Address:
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Moorenstraße 5
40225
Düsseldorf
Germany |
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Telephone:
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02118117687 |
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Email:
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Katharina.Foertsch@med.uni-duesseldorf.de |
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Affiliation:
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Universitätklinikum Düsseldorf, Klinik für Allgemeine Pädiatrie, Kinderkardiologie und Neonatologie |
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Name:
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Katharina
Förtsch |
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Address:
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Moorenstraße 5
40225
Düsseldorf
Germany |
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Telephone:
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02118117687 |
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Email:
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Katharina.Foertsch@med.uni-duesseldorf.de |
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Affiliation:
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Universitätklinikum Düsseldorf, Klinik für Allgemeine Pädiatrie, Kinderkardiologie und Neonatologie |
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Key inclusion & exclusion criteria
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Inclusion criteria: type 1 diabetes; at manifestation or with diabetes duration of at least one year; age 0-18
Exclusion criteria: acute infection
Age minimum:
0 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Type 1 diabetes mellitus
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E10
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Intervention(s)
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Group 1: 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 patients health record and with metabolic parameters.
Group 2: 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 patients health record and with metabolic parameters.
Group 3: 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 patients health record and with metabolic parameters.
Group 4: Determination of T cell response (FACS analysis) in patients without diabetes; age 5 to 18. Correlation of the results with data from the patients health record and with metabolic parameters.
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Primary Outcome(s)
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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(s)
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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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Source(s) of Monetary Support
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Universitätklinikum Düsseldorf Klinik für Allgemeine Pädiatrie, Kinderkardiologie und Neonatologie
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Ethics review
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Status: Approved
Approval date: 06/11/2014
Contact:
ethikkommission@med.uni-duesseldorf.de
Ethikkommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
+49-211-8119591
ethikkommission@med.uni-duesseldorf.de
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