Diagnosis and Physiopathology of Insulin Allergy (IA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Validation of cutaneous insulin tests
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Allergy tests
干预措施: Allergy tests (Procedure)
结局指标
主要结局
Validation of cutaneous insulin tests
时间窗: after 36 months
Response of cutaneous insulin tests in patients with IA (Insulin Allergy) at study completion.
次要结局
- Immunogenetic of patients with IA (Insulin Allergy)(after 36 months)