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Diagnosis and Physiopathology of Insulin Allergy (Allerdiab)

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ClinicalTrials.gov Identifier: NCT01407640
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Hypersensitivity Immediate Hypersensitivity Allergy Procedure: Allergy tests Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Allergy tests
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



Primary Outcome Measures :
  1. Validation of cutaneous insulin tests [ Time Frame: after 36 months ]
    Response of cutaneous insulin tests in patients with IA (Insulin Allergy) at study completion.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
France
Cochin Hospital
Paris, France, 75005
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Agnes Sola-Gazagnes, MD Assistance Publique - Hôpitaux de Paris

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01407640     History of Changes
Other Study ID Numbers: P081223
First Posted: August 2, 2011    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Insulin allergy
adverse drug reaction
diabetes
type 1 hypersensitivity
immediate hypersensitivity
type 4 hypersensitivity
insulin analogs
intradermal testing
insulin antibody
mast cell
CD+ TCELL

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypersensitivity
Diabetes Mellitus, Type 1
Hypersensitivity, Immediate
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Immune System Diseases
Autoimmune Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs