| NCT ID | NCT00097292 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South Florida |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | OBSERVATIONAL |
| Enrollment | 75,000 participants |
| Start Date | 2004-02-01 |
| Primary Completion | 2030-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 75,000 participants in total. It began in 2004-02-01 with a primary completion date of 2030-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rationale: The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and characterization of the early metabolic abnormalities in T1DM is steadily increasing. However, information regarding the natural history of T1DM remains incomplete. The TrialNet Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been designed to clarify this picture, and in so doing, will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM. Purpose: TrialNet is an international network dedicated to the study, prevention, and early treatment of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes. The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to enhance our understanding of the demographic, immunologic, and metabolic characteristics of individuals at risk for developing type 1 diabetes. The Natural History Study will screen relatives of people with type 1 diabetes to identify those at risk for developing the disease. Relatives of people with type 1 diabetes have about a 5% percent chance of being positive for the antibodies associated with diabetes. TrialNet will identify adults and children at risk for developing diabetes by testing for the presence of these antibodies in the blood. A positive antibody test is an early indication that damage to insulin-secreting cells may have begun. If this test is positive, additional testing will be offered to determine the likelihood that a person may develop diabetes. Individuals with antibodies will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the development of diabetes.
Eligibility Criteria
Inclusion Criteria: * Individuals 2 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling) * Individuals 2-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling) * Those aged 2 years to 45 years who are not family members and are known to have 1 or more islet antibodies Exclusion Criteria: To be eligible a person must not: * Have diabetes already * Have previous or current use of medications for the control of hyperglycemia/diabetes. * Currently be using immunosuppressive or immunomodulatory agents (topical and inhaled agents are acceptable) * Have known severe active diseases, and/or diseases which are likely to limit life expectancy or lead to the use of chronic immunosuppressive or immunomodulatory therapies during the course of the study
Contact & Investigator
TrialNet Central Information Center general info
📞 1-800-425-8361
Kevan Herold, M.D.
STUDY CHAIR
Yale University
Frequently Asked Questions
Who can join the NCT00097292 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 45 Years, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00097292 currently recruiting?
Yes, NCT00097292 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of South Florida to inquire about joining.
Where is the NCT00097292 trial being conducted?
This trial is being conducted at Orange, United States, San Francisco, United States, Stanford, United States, Denver, United States and 11 additional locations.
Who is sponsoring the NCT00097292 clinical trial?
NCT00097292 is sponsored by University of South Florida. The principal investigator is Kevan Herold, M.D. at Yale University. The trial plans to enroll 75,000 participants.
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