Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283264
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-12-14
Brief Title:
Assessment of Coeliac Disease in Patients With Type 2 Diabetes
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Assessment of Coeliac Disease in Patients With Type 2 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 87 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None