Immune Function and the Progression to T1D

NCT ID: NCT05899439

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-01

Study Completion Date

2085-01-01

Brief Summary

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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

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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.

Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Subjects with diabetes age 0 to 100 years

People who have not been diagnosed with type 1 diabetes

blood draw

Intervention Type OTHER

a peripheral blood draw

Subjects with type 1 diabetes age 0 to 100 years

People who have been diagnosed with type 1 diabetes

blood draw

Intervention Type OTHER

a peripheral blood draw

Interventions

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blood draw

a peripheral blood draw

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

0 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Juvenile Diabetes Research Foundation

OTHER

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kieran McGrail

Gainesville, Florida, United States

Site Status RECRUITING

The Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

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

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer L Hosford, MPH

Role: CONTACT

352-294-5759

Kieran McGrail

Role: CONTACT

(352) 273-9299

Facility Contacts

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Kieran McGrail

Role: primary

352-273-9299

Billur Akkaya, MD DPhil

Role: primary

614-688-1187

Maria Redondo, MD, PhD, MPH

Role: primary

832-822-1019

Franca Erhiawarie

Role: backup

832-824-3372

Other Identifiers

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PRO00043521

Identifier Type: OTHER

Identifier Source: secondary_id

P01AI042288

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201400709

Identifier Type: -

Identifier Source: org_study_id

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