Diagnosis and Physiopathology of Insulin Allergy (Allerdiab)
|ClinicalTrials.gov Identifier: NCT01407640|
Recruitment Status : Active, not recruiting
First Posted : August 2, 2011
Last Update Posted : July 6, 2016
Insulin allergy (IA) is still observed even with recombinant human insulin and insulin analogs.
Obviously, the usual attitude facing an allergy, i. e. exclusion of the allergen, poses problems in face of IA because insulin is often vital for the patient. IA is thus a complex situation in which a rigorous diagnostic procedure to identify the exact allergen is necessary to propose a therapeutic answer; the purpose of the study is 1/ to validate a diagnostic algorithm for patients presenting with possible allergy. 2/ to investigate immunogenetic profiles of patient with insulin allergy 3/ cellular mechanisms of IA.
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Hypersensitivity Immediate Hypersensitivity Allergy||Procedure: Allergy tests|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnosis and Physiopathology of Insulin Allergy (IA)|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2017|
Procedure: Allergy tests
1/ to validate a diagnostic algorithm for patients presenting with possible allergy. 2/ to investigate immunogenetic profiles of patient with insulin allergy 3/ cellular mechanisms of IA
- Validation of cutaneous insulin tests [ Time Frame: after 36 months ]Response of cutaneous insulin tests in patients with IA (Insulin Allergy) at study completion.
- Immunogenetic of patients with IA (Insulin Allergy) [ Time Frame: after 36 months ]Immunogenetic of patients with IA (Insulin Allergy) at study completion Determination of insulin epitopes that are involved in IA at study completion Determination of isotypes of anti insulin antibodies and whether specific isotypes are associated with susceptibility / protection at study completion
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407640
|Paris, France, 75005|
|Principal Investigator:||Agnes Sola-Gazagnes, MD||Assistance Publique - Hôpitaux de Paris|