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

NCT05171998 | Completed

• 1 other identifier: CT 253888
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• To determine whether SARS-CoV-2-specific T-cells cross-react with insulin producing cells in the pancreas of people with Type 1 diabetes.

  To measure if SARS-CoV-2-specific/infection-specific T-cells can cross-recognise insulin producing cells in the pancreas to potentially cause loss of insulin and type 1 diabetes.

  One blood draw at time of first diagnosis of Type 1 diabetes

Secondary Outcomes (1)

• 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

  6 months

Interventions

venous blood sample PROCEDURE

Phlebotomy procedure for a venous blood draw.

Also known as: blood tests

Eligibility Criteria

• Age: 8 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with new Type 1 diabetes.

You may qualify if:

• Participants must be 8 years or more old
• Participants must have the capacity to provide consent or assent after discussing the participant information sheet, with consent gained from their parent/guardian
• Diagnosis of Type 1 diabetes during the course of the COVID pandemic.

You may not qualify if:

• Participants under 8 years old.
• Inability to provide consent or assent/parental consent

Sponsors & Collaborators

• Cwm Taf University Health Board (NHS): lead
• Cardiff University: collaborator
• University of Oxford: collaborator
• Imperial College London: collaborator

Study Sites (1)

Cwm Taf Morgannwg University Health board

Llantrisant, Rhondda Cynon Taf, CF82 7XR, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole venous blood including peripheral blood mononuclear cells and serum.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Rhian Beynon

  Cwm Taf University Health Board (NHS)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: December 29, 2021
• Study Start: January 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)