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NCT06006468Completed

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

Source: ClinicalTrials.gov · Last updated 15 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
2250 (actual)
First submitted
20 Jun 2023
Start date
1 Feb 2023
Primary completion date
31 Dec 2023
Lead sponsor
Royal Devon and Exeter NHS Foundation Trust
NCT number
NCT06006468

What you commit to

  • Study type: Observational
  • Participants enrolled: 2250
  • From 1 Feb 2023 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Diagnosed with diabetes at time of original sample collection
  • Diagnosed with coeliac disease at time of original sample collection

Who the study is looking for

  • Exeter 10,000 study participants with stored serum samples
  • Consent for samples \& data to be used in further research.

Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NIHR Exeter Clinical Research Facility (Royal Devon University Healthcare NHS Foundation Trust)
Coordinator of this site? Confirm its status
ExeterUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.