TrialNet Pathway to Prevention of T1D
Public ClinicalTrials.gov record NCT00097292. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00097292
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 75,000 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 2 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2004
- Primary completion
- Jul 30, 2030
- Completion
- Jul 30, 2030
- Last update posted
- Jun 30, 2025
2004 – 2030
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Childrens Hospital of Orange County | Orange | California | 92868 | Recruiting |
| University of California San Francisco | San Francisco | California | 94143-0434 | Recruiting |
| Stanford University Medical Center | Stanford | California | 94305-5208 | Recruiting |
| Barbara Davis Center for Childhood Diabetes | Denver | Colorado | 80262 | Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | 06519 | Recruiting |
| University of Florida | Gainesville | Florida | 32601-0296 | Recruiting |
| Emory Children's Center | Atlanta | Georgia | 30322 | Recruiting |
| Riley Hospital for Children, Indiana University | Indianapolis | Indiana | 46202 | Recruiting |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | 58944 | Recruiting |
| The Children's Mercy Hospital | Kansas City | Missouri | 64111 | Recruiting |
| Columbia University | New York | New York | 10032 | Recruiting |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15213 | Recruiting |
| Vanderbilt University | Nashville | Tennessee | 37232 | Recruiting |
| University of Texas Medical Center at Dallas | Dallas | Texas | 75390-8858 | Recruiting |
| Baylor College of Medicine | Houston | Texas | 77030 | Recruiting |
| Benaroya Research Institute | Seattle | Washington | 98101-2795 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00097292, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 30, 2025 · Synced Sep 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00097292 live on ClinicalTrials.gov.