CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,250 enrolled
Drug / intervention
High genetic risk for type 1 diabetes +1 moregenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06006468
NCT06006468N/ACompleted

Evaluating ImmuNe Changes in the Evolution of Pre Type 1 Diabetes With Adult Onset

Royal Devon and Exeter NHS Foundation Trust·observational·Posted Aug 23, 2023·Updated Nov 15, 2024

In Brief

An observational study evaluating High genetic risk for type 1 diabetes and High gentic risk for Coeliac disease for Type 1 Diabetes and Type 1 Diabetes Mellitus Maturity Onset. Completed, enrolled 2,250 participants across 1 site.

Detailed Summary

Little is known about how type 1 diabetes or coeliac disease develop in adults. Studies following children at risk of type 1 diabetes from birth have shown that the marker of type 1 diabetes autoimmunity (antibodies against the insulin producing cells in the pancreas (Glutamic Acid Decarboxylase Autoantibodies (GADA), Insulin Autoantibodies (IAA), Zinc Transporter 8 Autoantibodies (ZnT8), Anti-tyrosine phosphatase-like insulinoma antigen 2 (IA-2))) can develop many years before glucose levels are raised and diabetes is diagnosed. In adults, it is unclear when antibodies develop in relation to high blood glucose levels and the diagnosis of type 1 diabetes. Similarly in coeliac disease it is unclear to what degree Tissue transglutaminase autoantibodies (TTG) in adults proceed the development of clinically diagnosed disease. The investigators will use samples collected and stored in The Exeter 10,000 volunteer research bank (https://exetercrfnihr.org/about/exeter-10000/) and so no new sample collection is required. This includes \~8000 participants with no history of coeliac disease or diabetes at recruitment. The investigators wish to determine prevalence of autoantibodies in the background adult population split by the highest genetic risk for type 1 diabetes and separately coeliac disease compared to a control population with lower genetic risk for these conditions. The investigators will also evaluate the proportion of these identified cases progressing to clinically diagnosed disease. The aim of this study is to investigate evidence of autoimmunity prior to disease development and generate pilot data for the validity of screening based on genetic predisposition for type 1 diabetes and coeliac disease.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
2023202420252026
First PostedAug 23, 2023
Enrollment StartFeb 1, 2023
Primary CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 2.9 years ago

Interventions

High genetic risk for type 1 diabetesgenetic

in individuals without diabetes comparison of prevalence of islet auto antibodies between individuals at high genetic risk of type 1 diabetes versus controls

High gentic risk for Coeliac diseasegenetic

in individuals without Coeliac disease comparison of prevalence of anti tissue transglutaminase antibodies between individuals at high genetic risk of coeliac disease versus controls