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临床试验/NCT06283264
NCT06283264尚未招募不适用

Assessment of Coeliac Disease in Patients With Type 2 Diabetes

Assiut University0 个研究点目标入组 100 人开始时间: 2024年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
1-Prevalence of coeliac disease among diabetic type 2 patient 2-its effect on glycemic control

研究概览

简要总结

This study aims to screen and diagnose coeliac disease in patients with type 2 diabetes and monitor the effect of gluten-free diet on the metabolic status

详细描述

Coeliac Disease (CD) is a chronic disease with long-term consequences if untreated . CD has been traditionally associated with autoimmune disorders as type 1 Diabetes . However, recent data suggest association with insulin resistance, metabolic syndrome and type 2 diabetes . In a recent study comparing prevalence of autoimmune markers in type 1 diabetes versus type 2, coeliac disease serologic markers were 5% versus 8.7% respectively . In a study published at Nature communication, a genetic link between Ig A levels, type 2 diabetes, and coeliac disease was found . Gluten, among other factors, is thought to play a proinflammatory role exaggerating the damage to β-cells in both type 1 and type 2 diabetes . Presentation of coeliac disease is very variable, ranging from asymptomatic, gastrointestinal symptoms, atypical symptoms, to malabsorption syndrome. Our interest of the very wide atypical presentations is poorly controlled type 2 diabetes . Moreover, it has been recently suggested that gluten-free diet improves glucose metabolism . Screening and diagnosing coeliac disease remain a highly controversial topic, especially in individuals with atypical or no symptoms. A lifelong gluten avoidance can be only justified by a solid diagnosis, achieved by histopathological diagnosis. Intestinal biopsy is invasive test with not that-accurate results. The new guidelines confirmed the accuracy of the no-biopsy approach, only in case of high-titre positive two antibody tests, as published by the European Society Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHN) . However, guidelines intended for adults still insist on biopsy for confirming final diagnosis . The only exception is the interim guidance during Corona Virus -19 ( COVID-19 ) allowing non-biopsy diagnosis with two separate serology tests . However, recent retrospective study confirmed that high titre tTG had more than 95% diagnostic rate, and duodenal biopsy was not needed . For screening, many approaches have been studied, with measuring total immunoglobulin A (IgA) and IgA tissue transglutaminase (tTG) is the obvious first choice. However, for resource-deficient economies, rapid easy cheap point-of-care tests for deamidated gliadin antibodies (DGP) have been suggested .

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients ≥18 years old
  • diagnosed with type 2 diabetes mellitus

排除标准

  • Patients already diagnosed with co-morbid autoimmune disorder
  • patient diagnosed as systemic lupus
  • diagnosed as rheumatoid arthritis
  • already diagnosed with coeliac disease

结局指标

主要结局

1-Prevalence of coeliac disease among diabetic type 2 patient 2-its effect on glycemic control

时间窗: One year

All willing participants, after obtaining informed consent, will be subjected to full history taking thorough clinical examination and the following measures investigations:- Anthropometric measures:- weight and height will be combined to report BMI in kg/m\^2). Metabolic assessment:- 1. HbA1c 2. Random blood glucose in mg/dl Measuring of :- 1-total immunoglobulin A (IgA) and IgA 2- tissue transglutaminase antibody (tTG-Ab).

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

Andrew Mohey Roshdy Khella

Principal investigator

Assiut University

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