Diagnosis and Physiopathology of Insulin Allergy

Not Applicable

Completed

• Conditions: Hypersensitivity; Allergy; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Immediate Hypersensitivity
• Interventions: Procedure: Allergy tests

• Registration Number: NCT01407640
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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

Study Timeline

• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-08-01
• Study First Posted: 2011-08-02
• Study Start: 2012-02-06
• Primary Completion: 2016-07-27
• Study Completion: 2016-07-27
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Allergy tests	Allergy tests

Primary Outcome Measures

Name	Time	Method
Validation of cutaneous insulin tests	after 36 months	Response of cutaneous insulin tests in patients with IA (Insulin Allergy) at study completion.

Secondary Outcome Measures

Name	Time	Method
Immunogenetic of patients with IA (Insulin Allergy)	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

Trial Locations

Locations (1)

Cochin Hospital; 🇫🇷 Paris, France