Immune Function and the Progression to T1D

Recruiting

• Conditions: Type 1 Diabetes
• Interventions: Other: blood draw

• Registration Number: NCT05899439
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study Start: 2005-01-01
• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07
• Primary Completion: 2085-01-01
• Study Completion: 2085-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2800

Inclusion Criteria

able to have blood drawn -

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with diabetes age 0 to 100 years	blood draw	People who have not been diagnosed with type 1 diabetes
Subjects with type 1 diabetes age 0 to 100 years	blood draw	People who have been diagnosed with type 1 diabetes

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Baylor College of Medicine, Center for Research Advancement - Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Kieran McGrail; 🇺🇸 Gainesville, Florida, United States