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NCT Number: NCT06283264

Assessment of Coeliac Disease in Patients With Type 2 Diabetes

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

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Key information

About this study

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 .

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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:-

    • HbA1c
    • Random blood glucose in mg/dl Measuring of :-

    1-total immunoglobulin A (IgA) and IgA 2- tissue transglutaminase antibody (tTG-Ab).

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Mohey

CONTACT

[email protected]

01221697739

Hussein Elamin, Professor

CONTACT

[email protected]

01004084187

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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