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临床试验/NCT05596656
NCT05596656已完成不适用

IgE-mediated Allergies Among Type 1 Diabetes Mellitus Children, Single Centre Observational Study

Mansoura University Children Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
positive skin prick test

研究概览

简要总结

an interviewer-administrated questionnaire was designed to take history of allergy in diabetic child come to outpatient clinic fulfilling inclusion criteria and used to collect data. Skin prick testing was performed to all diabetic children with history of allergy. Laboratory assessment of Serum Total IgE, IL5 and eosinophils%.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children with at least 2 Years duration of diabetes diagnosed by Criteria for the diagnosis of diabetes mellitus (ISPAD 2018) that include:
  • Classic symptoms of diabetes or hyperglycemic crisis, with plasma glucose concentration ≥11.1 mmol/L (200 mg/dL).
  • Fasting plasma glucose ≥7.0 mmol/L (≥126 mg/dL). Fasting is defined as no caloric intake for at least 8 hours.
  • Two-hour post load glucose ≥11.1 mmol/L (≥200 mg/dL) during an oral glucose tolerance test (OGTT).
  • HbA1c ≥6.5%.

排除标准

  • presence of other chronic disease associated with DM.

结局指标

主要结局

positive skin prick test

时间窗: 20 minutes

a wheal ≥3 mm diameter more than negative control for detection of specific IgE to one or more of common aeroallergens.

次要结局

未报告次要终点

研究者

发起方
Mansoura University Children Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Engy Osman Ahmed

assistant professor

Mansoura University Children Hospital

研究点 (1)

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