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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05171998
Recruitment Status : Completed
First Posted : December 29, 2021
Last Update Posted : June 2, 2022
Sponsor:
Collaborators:
Cardiff University
University of Oxford
Imperial College London
Information provided by (Responsible Party):
Cwm Taf University Health Board (NHS)

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 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

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: venous blood sample
    Phlebotomy procedure for a venous blood draw.
    Other Name: blood tests


Primary Outcome Measures :
  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. [ 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.


Secondary Outcome Measures :
  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 [ 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
whole venous blood including peripheral blood mononuclear cells and serum.


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with new Type 1 diabetes during the COVID pandemic.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Type 1 diabetes diagnosed before the COVID pandemic
  • Inability to provide consent or assent/parental consent

Information from the National Library of Medicine

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


Locations
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United Kingdom
Cwm Taf Morgannwg University Health board
Llantrisant, Rhondda Cynon Taf, United Kingdom, CF82 7XR
Sponsors and Collaborators
Cwm Taf University Health Board (NHS)
Cardiff University
University of Oxford
Imperial College London
Investigators
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Study Director: Rhian Beynon Cwm Taf University Health Board (NHS)
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Responsible Party: Cwm Taf University Health Board (NHS)
ClinicalTrials.gov Identifier: NCT05171998    
Other Study ID Numbers: CT 253888
First Posted: December 29, 2021    Key Record Dates
Last Update Posted: June 2, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes
Autoimmune Diseases
Immune System Diseases
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases