Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT05899439

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Interventions

blood draw

Study Details

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.

Conditions

Type 1 Diabetes

Study ID

NCT05899439

Start date

Jan 1, 2005

Status verified date

Apr, 2026

Completion date

Jan 1, 2085

Anticipated

Primary completion date

Jan 1, 2085

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria: able to have blood drawn -

Exclusion Criteria: none

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Study Design

Enrollment

2800 participants

Anticipated

Interventions and Outcome Measures

Arms

Subjects with diabetes age 0 to 100 years

People who have not been diagnosed with type 1 diabetes

Subjects with type 1 diabetes age 0 to 100 years

People who have been diagnosed with type 1 diabetes

Interventions

blood draw

a peripheral blood draw

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jennifer L Hosford, MPH

352-294-5759jennifer.hosford@peds.ufl.edu

Kieran McGrail

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

Locations

Kieran McGrail

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Kieran McGrail

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

Principal Investigator:

Todd Brusko, PhD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Billur Akkaya, MD DPhil

614-688-1187billur.akkaya@osumc.edu

Baylor College of Medicine, Center for Research Advancement - Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Maria Redondo, MD, PhD, MPH

832-822-1019redondo@bcm.edu

Franca Erhiawarie

832-824-3372Franca.Ofudu@bcm.edu

More Information

Sponsor

University of Florida

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Florida on 2026-04-09.