Assessment of Coeliac Disease in Patients With Type 2 Diabetes

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06283264
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assiut University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Additional Details

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 .

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Andrew Mohey

andrewmohey61@gmail.com

01221697739

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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