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Diagnosis and Physiopathology of Insulin Allergy (Allerdiab)

This study is currently recruiting participants.
Verified July 2012 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: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Hypersensitivity
Immediate Hypersensitivity
Allergy
 Procedure: Allergy tests

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Diagnosis and Physiopathology of Insulin Allergy (IA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 70
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Allergy tests

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407640

Contacts
Contact: Agnes Sola-Gazagnes, MD 0033142348388 agnes.sola@htd.aphp.fr
Contact: Raphaël SERREAU, MD, PhD 0033158411180 raphael.serreau@cch.aphp.fr

Locations
France
Hotel Dieu Hospital Recruiting
Paris, France, 75004
Principal Investigator: Agnes Sola-Gazagnes, MD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut Pasteur
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Agnes Sola-Gazagnes, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01407640     History of Changes
Other Study ID Numbers: P081223
Study First Received: June 28, 2011
Last Updated: July 25, 2012
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 23, 2013