Characterisation of the Immune Response to SARS-CoV-2 Infection / COVID-19 in Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT05171998|
Recruitment Status : Completed
First Posted : December 29, 2021
Last Update Posted : June 2, 2022
Emerging clinical details of the current SARS-CoV-2 pandemic have illustrated that there are multiple clinical presentations and outcomes of this viral infection. People with an infection have been reported to have a spectrum of disease from severe acute respiratory distress requiring ventilation, to mild respiratory or gastrointestinal symptoms and asymptomatic presentations. The SARS-CoV-2 pandemic has been accompanied with a substantial increase in the number of individuals presenting with new onset type 1 diabetes . Most individuals presenting with type 1 diabetes since the start of the COVID-19 pandemic are SARS-CoV-2 antibody positive. These findings suggest that SARS-CoV-2 infection can cause type 1 diabetes. Investigators have identified that many individuals presenting with type 1 diabetes since the start of the COVID-19 pandemic are SARS-CoV-2 positive by swab or blood test. Researchers have also observed that T cells in patients who have had COVID recognise some of the peptides in the pancreatic islet cells, which are responsible for production of insulin. These findings suggest that SARS-CoV-2 infection may be associated with new onset of type 1 diabetes.
The aim of this project is to understand the host immune response to infection with SARS-CoV-2 over time in convalescent newly diagnosed patients with type 1 diabetes, including acquired immune responses, gene expression profiling in peripheral blood and to identify host genetic variants associated with disease progressions or severity. Participants will have Type 1 diabetes and will have had a diagnosis of COVID-19 (confirmed by a positive nasopharyngeal swab PCR test and/or SARS-CoV-2 antibody test) and have recovered from COVID-19. Samples will be processed and analysed to explore the molecular mechanisms by which SARS-CoV-2 infection might precipitate immune attack on insulin-producing cells resulting in autoimmune diabetes.
|Condition or disease||Intervention/treatment|
|SARS-CoV2 Infection Diabetes Mellitus, Type 1||Procedure: venous blood sample|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Characterisation of the Immune Response to SARS-CoV-2 Infection in Type 1 Diabetes|
|Actual Study Start Date :||January 1, 2021|
|Actual Primary Completion Date :||June 1, 2021|
|Actual Study Completion Date :||June 1, 2021|
- Procedure: venous blood sample
Phlebotomy procedure for a venous blood draw.Other Name: blood tests
- To determine whether SARS-CoV-2-specific T-cells cross-react with insulin producing cells in the pancreas of people with Type 1 diabetes. [ Time Frame: One blood draw at time of first diagnosis of Type 1 diabetes ]To measure if SARS-CoV-2-specific T-cells can cross-recognise insulin producing cells in the pancreas to potentially cause loss of insulin and type 1 diabetes.
- To determine if expression of HLA A*02 and/or HLA A*24 is more common in Type 1 diabetes patients with SARS-CoV-2 cross-reactive T cells [ Time Frame: 6 months ]To determine if individuals that develop type 1 diabetes following SARS-CoV-2 infection are enriched for expression of HLA A*02 and/or HLA A*24
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05171998
|Cwm Taf Morgannwg University Health board|
|Llantrisant, Rhondda Cynon Taf, United Kingdom, CF82 7XR|
|Study Director:||Rhian Beynon||Cwm Taf University Health Board (NHS)|