Type 1 DiabetesNCT05899439
Immune Function and the Progression to T1D
An observational study of Type 1 Diabetes, run by University of Florida at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 0 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- blood draw
- How many people
- 2,800 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2005to 1 Jan 2085
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals age 0 to 100 with or without a diagnosis of type 1 diabetes and able/willing to have a blood draw
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Billur Akkaya, MD DPhil, 614-688-1187, billur.akkaya@osumc.edu
- Recruiting
Kieran McGrail
Gainesville, Florida, 32610
Kieran McGrail, 352-273-9299, mcgrail@pathology.ufl.edu
Todd Brusko, PhD
- Recruiting
Baylor College of Medicine, Center for Research Advancement - Texas Children's Hospital
Houston, Texas, 77030
Maria Redondo, MD, PhD, MPH, 832-822-1019, redondo@bcm.edu
Franca Erhiawarie, 832-824-3372, Franca.Ofudu@bcm.edu
About this study
Official title: Immune Function and the Progression to Type 1 Diabetes:
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.
Read the detailed 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.
- Conditions
- Type 1 Diabetes
- Being tested
- blood draw
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawOther
a peripheral blood draw
| Study group | Role | What they receive |
|---|---|---|
| Subjects with diabetes age 0 to 100 years | People who have not been diagnosed with type 1 diabetes Receives: Other: blood draw | |
| Subjects with type 1 diabetes age 0 to 100 years | People who have been diagnosed with type 1 diabetes Receives: Other: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: through study completion, up to 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jan 2005
- Primary completion1 Jan 2085 (estimated)
- Study completion1 Jan 2085 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899439
- Sponsor's protocol ID
- IRB201400709
- Other IDs
- PRO00043521, P01AI042288
- Status last verified
- Apr 2026
- First submitted
- 22 May 2023
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Function and the Progression to Type 1 Diabetes:
- ClinicalTrials.gov ID
- NCT05899439
- Acronym / sponsor ID
- IRB201400709
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 1 Jan 2085 (estimated)
- Study completion
- 1 Jan 2085 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with diabetes age 0 to 100 years | – | Other: blood drawPeople who have not been diagnosed with type 1 diabetes |
| Subjects with type 1 diabetes age 0 to 100 years | – | Other: blood drawPeople who have been diagnosed with type 1 diabetes |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals age 0 to 100 with or without a diagnosis of type 1 diabetes and able/willing to have a blood draw
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawa peripheral blood draw | Other | Subjects with diabetes age 0 to 100 years, Subjects with type 1 diabetes age 0 to 100 years |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by University of Florida at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer L Hosford, MPH (352-294-5759, jennifer.hosford@peds.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.