Immune Function and the Progression to T1D
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood draw.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: 0 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Immune Function and the Progression to Type 1 Diabetes:
Overview
To elucidate the mechanisms by which type 1 diabetes-associated genes; IFIH1, TYK2, IKZF4, as well as total genetic risk, impart functional immunoregulatory abnormalities that result in expansion of self-reactive adaptive immune cells, defective regulatory/effector mechanisms in T cells, inflammatory antigen presenting cells, and abnormal immune function in T cells and B cells.
Detailed description
Newly proposed studies will identify the inflammatory cues that draw immune cells into islets for disease initiation (Project 1); probe the motility of immune cells through inflamed vasculature to the target organ and antigen priming sites within secondary lymphatics (Project 2); and characterize the T1D-associated adaptive immune signatures in blood and immune tissues (Project 3).
The overall hypothesis of the renewed P01 states: 1) the impact of T1D-risk variants will vary by tissue, cell subset, and activation state, and 2) risk variants, cellular stress, and defects in immunologic pathways are key to engender the autoimmune destruction of pancreatic B-cells that results in T1D.
Interventions
- Other blood draw
a peripheral blood draw
Primary outcome measures
- the number of participants who become at risk for development of type 1 diabetes [Time frame: through study completion, up to 25 years]
- Genetic risk of type 1 diabetes [Time frame: through study completion, up to 25 years]
Eligibility criteria
Inclusion Criteria: able to have blood drawn -
Exclusion Criteria: none
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 3 centers
- Kieran McGrail — Gainesville
- The Ohio State University — Columbus
- Baylor College of Medicine, Center for Research Advancement - Texas Children's Hospital — Houston
Identifiers
NCT: NCT05899439 · IRB201400709 · PRO00043521 · P01AI042288