Diagnosis and Physiopathology of Insulin Allergy (Allerdiab)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01407640|
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : March 19, 2018
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||Phase|
|Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Hypersensitivity Immediate Hypersensitivity Allergy||Procedure: Allergy tests||Not Applicable|
|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)|
|Actual Study Start Date :||February 6, 2012|
|Actual Primary Completion Date :||July 27, 2016|
|Actual Study Completion Date :||July 27, 2016|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|