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临床试验/NCT04536285
NCT04536285已完成不适用

Clinical Characteristics and Outcome of Hospitalized Children and Adolescent Patients With Type 1 Diabetes During the COVID-19 Pandemic: Data From a Single Center Surveillance Study in Egypt

Ain Shams University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Clinical characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.

研究概览

简要总结

Although reports showed that children with well controlled diabetes do not appear to have increased risk of infection with SARS-CoV-2, however data are scarce regarding the extent to which clinical and demographic data of patient could modify the outcome and severity of the disease. Additionally, the link between covid-19 and diabetes remains controversial.

详细描述

Data from poorly controlled patients with type 1 diabetes remains controversial regarding whether diabetes itself could increases the susceptibility of infection with SARS-CoV-2 and subsequently impacts the outcomes in these patients , or the SARS-CoV-2 subsequently affects the risk of type 1 diabetes and increase in the prevalence of severe DKA.

Poorly controlled diabetes and chronic hyperglycemia creates a state of low grade chronic inflammation, which may explain the underlying mechanism of increased susceptibility to infection and infer the outcome in patients with diabetes .

Poorly controlled diabetes has been linked to multiple derangements of immune system including inhibition of lymphocyte proliferation in response to different stimuli, as well as impaired monocyte/macrophage function together with increased synthesis of pro-inflammatory cytokines and adhesion molecules that mediate tissue inflammation .

Few data links the association between development of diabetic ketoacidosis in patients with COVID-19, where the infection could trigger higher stressful conditions, with the release of stress hormones leading to increased blood glucose levels and abnormal glucose variability .

The extent to which clinical and demographic data of patients with type 1 diabetes modifies the outcome and severity of the disease seems entirely unclear and is the question of several researches.

研究设计

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

入排标准

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

入选标准

  • All patients with type 1 diabetes admitted to Pediatrics Hospital, Ain Shams University in the period between May to July
  • Age: less than 18 years old.

排除标准

  • Children with other forms of diabetes, including: type 2, monogenic forms and secondary diabetes

结局指标

主要结局

Clinical characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.

时间窗: 4 months

complications and comorbidities associated with diabetes

Laboratory characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.

时间窗: 4 months

Acute phase reactants

Prognosis of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.

时间窗: 4 month

Intensive care admission

次要结局

  • Incidence of new onset type 1 diabetes among confirmed cases of Covid-19 infection among children and adolescents(4 months)
  • Presentation of diabetes and its acute complications among pediatric and adolescent patients with type 1 diabetes during COVID-19 Pandemic in Egypt(4 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman Monir Sherif

Professor of Pediatrics

Ain Shams University

研究点 (1)

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