Allergy, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Hypersensitivity, Immediate Hypersensitivity
Conditions
Keywords
Insulin allergy, adverse drug reaction, diabetes, type 1 hypersensitivity, immediate hypersensitivity, type 4 hypersensitivity, insulin analogs, intradermal testing, insulin antibody, mast cell, CD+ TCELL
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
Interventions
PROCEDUREAllergy 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
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Patients aged 18 years old and more with a written informed consent * Experimental group : type 1 or type 2 diabetic patients with insulin allergy based on clinical criteria * Active Comparator group: type 1 or type 2 diabetic patients insulin treated without insulin allergy
Exclusion criteria
: * Not willing participate * Pregnancy * Age below 18 years * Severe Renal failure * Severe Anaphylactic shock only for the experimental group * No social security overture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of cutaneous insulin tests | after 36 months | Response of cutaneous insulin tests in patients with IA (Insulin Allergy) at study completion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed