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Assessment of Coeliac Disease in Patients With Type 2 Diabetes

Assessment of Coeliac Disease in Patients With Type 2 Diabetes

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06283264
Enrollment
100
Registered
2024-02-28
Start date
2024-03-15
Completion date
2026-12-30
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Brief summary

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

Detailed description

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 .

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

Inclusion criteria

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

Exclusion criteria

1. Patients already diagnosed with co-morbid autoimmune disorder 2. patient diagnosed as systemic lupus 3. diagnosed as rheumatoid arthritis 4. already diagnosed with coeliac disease

Design outcomes

Primary

MeasureTime frameDescription
1-Prevalence of coeliac disease among diabetic type 2 patient 2-its effect on glycemic controlOne yearAll 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).

Contacts

Primary ContactAndrew Mohey
andrewmohey61@gmail.com01221697739
Backup ContactHussein Elamin, Professor
elamin67@yahoo.com01004084187

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026