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临床试验/NCT03257566
NCT03257566Unknown不适用

Risk Factors of Incidence of Hypothyroidism in Patients With Type 1 Diabetes

Assiut University0 个研究点目标入组 300 人开始时间: 2017年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
主要终点
Screening the incidence of hypothyroidism in patients with type 1 diabetes

研究概览

简要总结

Therefore, for early detection of hypothyroidism in children with type 1 diabetes, it is suggested to measure anti-thyroid antibodies and thyroid stimulating hormone at disease onset and in yearly intervals after the age of 12 yr. Furthermore, the International Society for Pediatric and Adolescent Diabetes Consensus Clinical Guidelines recommend the screening of thyroid function by analysing circulating thyroid stimulating hormone at the diagnosis of diabetes and, thereafter every 2nd yr. in asymptomatic individuals without goitre and more frequent if goitre present .

详细描述

Type 1 diabetes is an organ-specific autoimmune disease characterized by the selective destruction of pancreatic β-cells. The histopathology of type 1 diabetes is defined by a decreased β-cell mass infiltration of mononuclear cells into the islets of Langerhans , this lesion was later called 'insulitis', and it is the hallmark of the disease .

Insulitis was observed in 70% of patients with acute onset type 1 diabetes and concluded that this disease was caused by a β-cell-specific autoimmune process .

Furthermore, in a study demonstrated cellular autoimmunity in patients with type 1 diabetes using the leukocyte migration test and speculated that cellular hypersensitivity was the counter part of lymphocytic infiltration in islets . Therefore, it is speculated that cell-mediated immunity could play an important part in the pathogenesis of type 1 diabetes .

As a view suggesting that type 1 diabetes is an autoimmune disease, there is some evidence that type 1 diabetes is often complicated with other autoimmune diseases or that anti-islet antibodies precede the clinical onset of the disease.

So, it is found that type 1 diabetes is frequently associated with other organ-specific autoimmune diseases, including hypothyroidism , pernicious anaemia, and idiopathic Addison's disease .The most common coexisting organ autoimmune disease is hypothyroidism (>90%), the prevalence of anti-thyroid autoantibodies in children with type 1 diabetes at disease onset is about 20% .

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
8 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with type 1 diabetes aging between 8 - 15 y .

排除标准

  • Cases with hyperthyroidism .
  • Areas known to have endemic goitre due to nutritional iodine deficiency .
  • History of maternal hypothyroidism and / or congenital hypothyroidism .
  • Children known to be normoglycaemic with already presented thyroid dysfunction .
  • Children with multiple endocrinopathies .
  • Children under treatment with drugs inducing hypothyroidism like amiodarone , lithium .
  • Children under treatment with drugs affecting insulin secretion like steroids , growth hormone therapy .

结局指标

主要结局

Screening the incidence of hypothyroidism in patients with type 1 diabetes

时间窗: after 1-2 years after diagnosis of Diabetes

Measuring of thyroid stimulating hormone in patients with type 1 diabetes

次要结局

未报告次要终点

研究者

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

Romany Safwat

principal investigator

Assiut University

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