Status:
RECRUITING
TrialNet Pathway to Prevention of T1D
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Diabetes Association
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
2-45 years
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). Gen...
Detailed Description
Detailed Description: The Pathway to Prevention Study is conducted in two parts: * Screening * Monitoring (annual and semi-annual depending on risk) In Screening , a simple blood test is done to sc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2030
Estimated Enrollment :
75000 Patients enrolled
Trial Details
Trial ID
NCT00097292
Start Date
February 1 2004
End Date
July 31 2030
Last Update
July 1 2025
Active Locations (22)
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1
Childrens Hospital of Orange County
Orange, California, United States, 92868
2
University of California San Francisco
San Francisco, California, United States, 94143-0434
3
Stanford University Medical Center
Stanford, California, United States, 94305-5208
4
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, United States, 80262