NCT01407640

Diagnosis and Physiopathology of Insulin Allergy

Diagnosis and Physiopathology of Insulin Allergy (IA)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Phenotype of the patient Investigation of allergy per intradermal testing using a wide range of insulin preparations Determination of immunologic and immunogenetic profile particularly CD4 + T cells and mast cells

Conditions

• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Hypersensitivity
• Immediate Hypersensitivity
• Allergy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-02-06
• Primary completion: 2016-07-27
• Completion: 2016-07-27
• First posted: 2011-08-02
• Last updated: 2025-09-12

Locations

1 site across 1 country: France