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
- Diseases
- Type 1 diabetes, Type 2 diabetes
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NIHR Exeter Clinical Research Facility (Royal Devon University Healthcare NHS Foundation Trust) Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.