Immune Function and the Progression to T1D

Immune Function and the Progression to Type 1 Diabetes:

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05899439

Enrollment

2800

Registered

2023-06-12

Start date

2005-01-01

Completion date

2085-01-01

Last updated

2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Brief summary

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

OTHERblood draw

a peripheral blood draw

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

0 Years to 100 Years

Healthy volunteers

Yes

Inclusion criteria

able to have blood drawn -

Exclusion criteria

none \-

Design outcomes

Primary

Measure	Time frame	Description
the number of participants who become at risk for development of type 1 diabetes	through study completion, up to 25 years	the number of participants who become at risk for development of type 1 diabetes
Genetic risk of type 1 diabetes	through study completion, up to 25 years	the number of people in different genetic risk groups who develop type 1 diabetes

Countries

United States

Contacts

CONTACTJennifer L Hosford, MPH

jennifer.hosford@peds.ufl.edu352-294-5759

CONTACTKieran McGrail

mcgrail@pathology.ufl.edu(352) 273-9299

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026