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TrialNet Pathway to Prevention of T1D

NCT00097292 · University of South Florida
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
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 screen for the presence of diabetes-related biochemical autoantibodies (GAD and mIAA). Additional autoantibodies ICA, IA-2A, and ZnT8A will also measured in individuals positive for mIAA. ICA, IA-2A, and ZnT8A will be measured in individuals positive for GAD. Participants can go to a TrialNet Clinical Center, Affiliate, or request a screening kit to have their blood drawn by a local physician or laboratory. Participants will be provided with their screening results within 4-6 weeks. If autoantibodies are present, participants will be invited to have additional testing to determine their average risk of developing diabetes over the next 5 years. Participants that are single autoantibody positive will be re-tested annually for the development of multiple autoantibodies. Multiple autoantibody positive participants will undergo an eligibility visit which will include an Oral Glucose Tolerance Test (OGTT), re-testing for biochemical and islet cell autoantibodies if needed, and measurement of HbA1c. Multiple autoantibody positive individuals with a normal glucose tolerance and an HbA1c \< 6.0% will be asked to come for follow-up on annual basis; multiple autoantibody positive individuals with an abnormal glucose tolerance or an HbA1c ≥ 6.0%will be asked to come for follow-up visits on semi-annual basis. Participants will be monitored for possible progression towards type 1 diabetes and may be offered the opportunity to enter into a prevention study such (e.g., Oral Insulin prevention study) or an early treatment study if they are diagnosed with type 1 diabetes while participating in the Natural History Study.
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
Study design
Enrollment target: 75000 participants
Age groups: child, adult
Timeline
Starts: 2004-02-01
Estimated completion: 2030-07-31
Last updated: 2025-07-01
Primary outcomes
  • Development of type 1 diabetes (Monitoring is provided once or twice annually depending on risk level)
Sponsor
University of South Florida · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Diabetes Association, National Institute of Allergy and Infectious Diseases (NIAID), National Center for Research Resources (NCRR)
Contacts & investigators
ContactTrialNet Central Information Center general info · contact · 1-800-425-8361
InvestigatorKevan Herold, M.D. · study_chair, Yale University
All locations (22)
Childrens Hospital of Orange CountyRecruiting
Orange, California, United States
University of California San FranciscoRecruiting
San Francisco, California, United States
Stanford University Medical CenterRecruiting
Stanford, California, United States
Barbara Davis Center for Childhood DiabetesRecruiting
Denver, Colorado, United States
Yale University School of MedicineRecruiting
New Haven, Connecticut, United States
University of FloridaRecruiting
Gainesville, Florida, United States
Emory Children's CenterRecruiting
Atlanta, Georgia, United States
Riley Hospital for Children, Indiana UniversityRecruiting
Indianapolis, Indiana, United States
Joslin Diabetes CenterRecruiting
Boston, Massachusetts, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
The Children's Mercy HospitalRecruiting
Kansas City, Missouri, United States
Columbia UniversityRecruiting
New York, New York, United States
Children's Hospital of Pittsburgh of UPMCRecruiting
Pittsburgh, Pennsylvania, United States
Vanderbilt UniversityRecruiting
Nashville, Tennessee, United States
University of Texas Medical Center at DallasRecruiting
Dallas, Texas, United States
Baylor College of MedicineRecruiting
Houston, Texas, United States
Benaroya Research InstituteRecruiting
Seattle, Washington, United States
Walter and Eliza Hall InstituteRecruiting
Parkville, Victoria, Australia
The Hospital for Sick ChildrenRecruiting
Toronto, Ontario, Canada
University of TurkuSuspended
Turku, Finland
Vita-Salute San Raffaele UniversitySuspended
Milan, Italy
University of BristolSuspended
Bristol, United Kingdom