Immune Function and the Progression to T1D
3 other identifiers
observational
2,800
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2005
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 22, 2023
CompletedFirst Posted
Study publicly available on registry
June 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2085
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2085
April 9, 2026
April 1, 2026
80.1 years
May 22, 2023
April 3, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
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
a peripheral blood draw
Eligibility Criteria
Individuals age 0 to 100 with or without a diagnosis of type 1 diabetes and able/willing to have a blood draw
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Kieran McGrail
Gainesville, Florida, 32610, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Baylor College of Medicine, Center for Research Advancement - Texas Children's Hospital
Houston, Texas, 77030, United States
Biospecimen
Sample collections, mainly peripheral blood but also discarded clinical samples, will occur at clinics, research space, and special event spaces on the University of Florida campus and remotely via lab collection. Genetic analysis will be performed related to developing a genetic model for predicting type 1 diabetes in the general population.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2023
First Posted
June 12, 2023
Study Start
January 1, 2005
Primary Completion (Estimated)
January 1, 2085
Study Completion (Estimated)
January 1, 2085
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.