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临床试验/NCT05442398
NCT05442398已完成不适用

Detection of Celiac Disease Among Suspected Patients With Type 1 Diabetes Mellitus

Mohamed Salah Ahmed Ali1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2022年7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
41
试验地点
1
主要终点
HbA1c

研究概览

简要总结

The aim of the present study is to detect Celiac Disease among suspected patients with Type 1 Diabetes Mellitus who admitted to Assiut University Children's Hospital during one year duration

详细描述

Type 1 diabetes mellitus (T1DM) is an immune-mediated disease characterized by reduced insulin secretion by islet Beta cells in the pancreas that leads to insulin deficiency . Because of a common genetic background and interaction between environmental and immunological factors, Patients with T1DM are at a great risk for developing autoimmune diseases. It is well recognized that T1DM can be associated with celiac disease (CD) and autoimmune thyroid disorders (ATD). Recent studies regarding CD and T1DM have indicated that the frequency of this association can vary from 1.7% to 16% . Also other autoimmune diseases may be noted such as Addison's disease and vitiligo.

Celiac disease is an autoimmune enteropathy that is caused by permanent susceptibility to gluten (a protein found in wheat, barley, and rye) in genetically susceptible individuals .

CD develops with symptoms, such as steatorrhea, weight loss, developmental disorder, abdominal pain, and nutritional symptoms (e.g. vitamin deficiency), and is improved shortly after elimination of gluten-containing foods .

Extraintestinal signs and symptoms include iron-deficiency anemia, chronic fatigue, failure to thrive, stunted or short stature, delayed puberty, amenorrhea, recurrent aphthous stomatitis, dermatitis herpetiformis - like rash, fracture with inadequate traumas, osteopenia, osteoporosis.

Since the majority of CD patients can be asymptomatic, screening for CD at the time of T1DM diagnosis is recommended . In seronegative cases at the first screening, if there are no CD symptoms, regular screening every 2-5 years is recommended. However, in patients with CD symptoms or history of CD in first-degree relatives more frequent screening is recommended . Testing of asymptomatic CD would provide a prompt diagnosis of CD and enable better metabolic control for T1DM patients .

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

  • Type 1 Diabetes mellitus
  • Symptoms and signs suggestive of Celiac disease.
  • Age : 1-18 years old

排除标准

  • No symptoms or signs suggestive of celiac disease.
  • Patients who are Non CD gluten hypersensitivity
  • Age : less than 1 year old.

结局指标

主要结局

HbA1c

时间窗: 1 day visit

Less than 5.7% Pre-diabetes: 5.7% to 6.4% Diabetes: 6.5% or higher

Anti-tissue transglutaminase (anti-tTG) antibodies IgA-IgG

时间窗: within 2 weeks

negative less than 10 positive if more than 10

Total IGA

时间窗: within 2 weeks

normal range 61-348

次要结局

未报告次要终点

研究者

发起方
Mohamed Salah Ahmed Ali
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Salah Ahmed Ali

Physician

Assiut University

研究点 (1)

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