跳至主要内容
临床试验/NCT03169413
NCT03169413Unknown不适用

Human Leucocytic Antigen Typing and Mutation of Adenosine Triphosphate Sensitive Potassium Channel Gene in Diabetic Patients Diagnosed Under the Age of One Year.

Assiut University0 个研究点目标入组 100 人开始时间: 2018年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Human Leucocytic antigen typing and mutation of adenosine triphosphate sensitive potassium channel gene in diabetic patients diagnosed under the age of one year.

研究概览

简要总结

Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia resulting from defects in insulin secretion, insulin action, or both.

According to American Diabetes Association diabetes can be classified into the following general categories: Type one diabetes (due to beta cell destruction, usually leading to absolute insulin deficiency), Type two diabetes (due to a progressive insulin secretory defect on the background of insulin resistance), Gestational diabetes mellitus and specific types of diabetes due to other causes, example monogenic diabetes syndromes (such as neonatal diabetes and maturity-onset diabetes of the young, diseases of the exocrine pancreas, and drug induced diabetes.

详细描述

Type one diabetes mellitus is one of the most common endocrine and metabolic conditions in childhood, it accounts for 5-10 percent of all diabetes cases.

Three-quarters of all cases of type one diabetes are diagnosed in individuals under eighteen years of age.

Data on incidence of childhood onset type one diabetes mellitus are very limited. Data from large epidemiological studies worldwide indicate that on an annual basis, the overall increase in the incidence of type one diabetes mellitus is around three percent.

The incidence rate increases from birth and peaks between the ages of ten to fourteen years. There is increase in incidence of type one diabetes mellitus throughout the world is especially, marked in young children, Registries in Europe suggest that incidence of type one diabetes mellitus were highest in the youngest age-group less than four years There is a seasonal pattern in the onset of type one diabetes mellitus with increased cases during late autumn, winter, and early spring.

Although most common autoimmune diseases usually affect females, but girls and boys are equally affected with type one diabetes mellitus in young populations.

研究设计

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

入排标准

年龄范围
1 Year 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diabetic patients with disease onset under the age of one year according to American Diabetes Association criteria 2016 which include:
  • Fasting plasma glucose level at or above 7 millimol/Litre.
  • Plasma glucose at or above 11.1 millimol/Litre two hours after a 1.75 gram/kilogram oral glucose load as in a glucose tolerance test.
  • Symptoms of hyperglycemia and random plasma glucose at or above 11.1 millimol/Litre.
  • Glycated hemoglobin at or above 48 millimol/mol.

排除标准

  • Diabetic children with the disease onset above the age of one year.

结局指标

主要结局

Human Leucocytic antigen typing and mutation of adenosine triphosphate sensitive potassium channel gene in diabetic patients diagnosed under the age of one year.

时间窗: At time of diagnosis with diabetes under the age of one year

Polymerase chain reaction / Deoxyribonucleic acid sequencing

次要结局

  • dentification of possible demographic and environmental risk factors associated with increased risk of diabetes in diabetic patient under the age of one year.(Within two years)
  • Rate of diabetes mellitus in patients under age of one year attending pediatric endocrinology unit in Pediatric assiut University Hospital(Within two years)

研究者

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

Shimaa Kamal

Principle Investigator

Assiut University

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