Immune Function and the Progression to T1D

Type 1 Diabetes Clinical Trial

Official title:

Immune Function and the Progression to Type 1 Diabetes:

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899439
• Other study ID #: IRB201400709
• Secondary ID: PRO00043521P01AI
• Status: Recruiting
• Start date: January 1, 2005
• Est. completion date: January 1, 2085

Study information

• Verified date: June 2023
• Source: University of Florida
• Contact: Jennifer L Hosford, MPH
• Phone: 352-294-5759
• Email: jennifer.hosford[@]peds.ufl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2800
• Est. completion date: January 1, 2085
• Est. primary completion date: January 1, 2085
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 100 Years

Eligibility

Inclusion Criteria: able to have blood drawn -

Exclusion Criteria: none

-

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• blood draw
a peripheral blood draw

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio
United States	Kieran McGrail	Gainesville	Florida
United States	Baylor College of Medicine, Center for Research Advancement - Texas Children's Hospital	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	Juvenile Diabetes Research Foundation, National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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