Immune Function and the Progression to T1D

Immune Function and the Progression to Type 1 Diabetes:

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: blood draw

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 Type: Observational
• Enrollment (Estimated): 2800

Contacts and Locations

• Study Contact: Name: Jennifer L Hosford, MPH; Phone Number: 352-294-5759; Email: jennifer.hosford@peds.ufl.edu
• Study Contact Backup: Name: Kieran McGrail; Phone Number: (352) 273-9299; Email: mcgrail@pathology.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • Kieran McGrail
      • Contact: Kieran McGrail; Phone Number: 352-273-9299; Email: mcgrail@pathology.ufl.edu
      • Principal Investigator: Todd Brusko, PhD
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
      • Contact: Billur Akkaya, MD DPhil; Phone Number: 614-688-1187; Email: billur.akkaya@osumc.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine, Center for Research Advancement - Texas Children's Hospital
      • Contact: Maria Redondo, MD, PhD, MPH; Phone Number: 832-822-1019; Email: redondo@bcm.edu
      • Contact: Franca Erhiawarie; Phone Number: 832-824-3372; Email: Franca.Ofudu@bcm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Individuals age 0 to 100 with or without a diagnosis of type 1 diabetes and able/willing to have a blood draw

Description

Inclusion Criteria: able to have blood drawn -

Exclusion Criteria: none

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with diabetes age 0 to 100 years; People who have not been diagnosed with type 1 diabetes	Other: blood draw; a peripheral blood draw
Subjects with type 1 diabetes age 0 to 100 years; People who have been diagnosed with type 1 diabetes	Other: blood draw; a peripheral blood draw

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Juvenile Diabetes Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2005
• Primary Completion (Estimated): January 1, 2085
• Study Completion (Estimated): January 1, 2085

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: IRB201400709; PRO00043521 (Other Identifier: University of Florida); P01AI042288 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: the data generated from the proposed studies will be presented at national or international conferences and published in a timely fashion. Investigators associated with this P01 have a record of publishing in pre-print servers and favoring open-access journals, when appropriate. The investigator will implement field standard, open-source tools including those developed by investigators on this proposal for data processing. Importantly, raw data, processed data, and metadata will be stored locally as well as deposited on public databases as detailed further below. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive PubMed Central. Evidence of this is provided in the attached biosketches.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No