Diagnosis and Physiopathology of Insulin Allergy (Allerdiab)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborators:
Institut Pasteur
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01407640
First received: June 28, 2011
Last updated: August 1, 2013
Last verified: July 2013

June 28, 2011
August 1, 2013
February 2012
September 2014   (final data collection date for primary outcome measure)
Validation of cutaneous insulin tests [ Time Frame: after 36 months ] [ Designated as safety issue: Yes ]
Response of cutaneous insulin tests in patients with IA (Insulin Allergy) at study completion.
Same as current
Complete list of historical versions of study NCT01407640 on ClinicalTrials.gov Archive Site
Immunogenetic of patients with IA (Insulin Allergy) [ Time Frame: after 36 months ] [ Designated as safety issue: Yes ]
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
Same as current
Not Provided
Not Provided
 
Diagnosis and Physiopathology of Insulin Allergy
Diagnosis and Physiopathology of Insulin Allergy (IA)

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.

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

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Hypersensitivity
  • Immediate Hypersensitivity
  • Allergy
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
Other Name: Allergy tests
Experimental: 1
Allergy tests
Intervention: Procedure: Allergy tests

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
February 2015
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Agnes Sola-Gazagnes, MD 0033142348388 agnes.sola@htd.aphp.fr
Contact: Raphaël SERREAU, MD, PhD 0033158411180 raphael.serreau@cch.aphp.fr
France
 
NCT01407640
P081223
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
  • Institut Pasteur
  • Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Agnes Sola-Gazagnes, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP