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NCT Number: NCT05899439

Immune Function and the Progression to T1D

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

0 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kieran McGrail, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

able to have blood drawn -

Exclusion criteria

none

-

Treatment and study plan

Blood Draw

Other

a peripheral blood draw

Primary outcomes

  1. the number of participants who become at risk for development of type 1 diabetes

    Time frame: through study completion, up to 25 years

    the number of participants who become at risk for development of type 1 diabetes

  2. Genetic risk of type 1 diabetes

    Time frame: through study completion, up to 25 years

    the number of people in different genetic risk groups who develop type 1 diabetes

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer L Hosford, MPH

CONTACT

[email protected]

352-294-5759

Kieran McGrail

CONTACT

[email protected]

(352) 273-9299

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Juvenile Diabetes Research Foundation
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Immune Function and the Progression to Type 1 Diabetes:

Important dates

Study start
2005
Primary completion
2085
Study completion
2085
First posted
Jun 12, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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