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Characterisation of the Immune Response to SARS-CoV-2 Infection / COVID-19 in Type 1 Diabetes

NCT05171998 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-08-15

No results posted yet for this study

Summary

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 \[1\]. 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 and other common pathogens 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 and other common infections might precipitate immune attack on insulin-producing cells resulting in autoimmune diabetes.

Conditions

  • SARS-CoV2 Infection Common Pathogens
  • Diabetes Mellitus, Type 1

Interventions

PROCEDURE

venous blood sample

Phlebotomy procedure for a venous blood draw.

Sponsors & Collaborators

  • Cardiff University

    collaborator OTHER

  • University of Oxford

    collaborator OTHER

  • Imperial College London

    collaborator OTHER

  • Cwm Taf University Health Board (NHS)

    lead OTHER_GOV

Principal Investigators

  • Rhian Beynon · Cwm Taf University Health Board (NHS)

Eligibility

Min Age
8 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2024-07-01
Completion
2024-07-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05171998 on ClinicalTrials.gov