TrialNet Pathway to Prevention of T1D

StatusRecruiting
PhaseNot specified
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Jul 2025 to Jul 31, 2030
    • Start date: Feb 2004 to Feb 1, 2004
    v41
  2. Eligibility criteria expanded, about 9 wordsv40
  3. Site contacts updated at 1 of 22 sitesv39
  4. Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to University of South Florida
    • Collaborators: 3 to 4
    v38
  5. Collaborators reorderedv37
Show 35 earlier versionsHide 35 earlier versions
  1. Study sites: 23 to 22v36
  2. Site contacts updated at 1 of 23 sites
    • Collaborators: 4 to 3
    v35
  3. Study title expanded, about 2 wordsv34
  4. Site contacts updated at 1 of 23 sitesv33
  5. Primary and study completion dates: Jul 2019 to Jul 2025
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 31 words
    v32
  6. Site contacts updated at 13 of 23 sitesv31
  7. Re-verified, no change to tracked fieldsv30
  8. Study sites revised (23)v29
  9. Study sites: 25 to 23v28
  10. Study sites: 21 to 25v27
  11. Study title shortened, about 6 words
    • Study description expanded, about 1 word
    v26
  12. Collaborators: 5 to 4v25
  13. Re-verified, no change to tracked fieldsv24
  14. Primary and study completion dates: Jul 2014 to Jul 2019v23
  15. Site contacts updated at 1 of 21 sitesv22
  16. Site contacts updated at 1 of 21 sitesv21
  17. Primary completion date: Jul 2014
    • Study completion date: Jun 2014 to Jul 2014
    • Study description expanded, about 2 words
    v20
  18. Study sites: 20 to 21v19
  19. Site contacts updated at 5 of 20 sitesv18
  20. Site contacts updated at 6 of 20 sites
    • Study description expanded, about 1 word
    v17
  21. Site contacts updated at 2 of 20 sitesv16
  22. Study sites: 19 to 20v15
  23. Re-verified, no change to tracked fieldsv14
  24. Study completion date: Jun 2009 to Jun 2014
    • Site contacts updated at 1 of 19 sites
    v13
  25. Site contacts updated at 1 of 19 sitesv12
  26. Re-verified, no change to tracked fieldsv11
  27. Study completion date: Jun 2008 to Jun 2009
    • Site contacts updated at 1 of 19 sites
    • Collaborators: 4 to 5
    • Study description shortened, about 1 word
    v10
  28. Study sites: 18 to 19v9
  29. Re-verified, no change to tracked fieldsv8
  30. Study sites revised (18)v7
  31. 2 versions Re-verified since May 18, 2006, no change to tracked fieldsv5-v6
  32. Site contacts updated at 18 of 18 sitesv4
  33. Site details revised at 4 of 18 sitesv3
  34. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00097292
Lead Sponsor University of South Florida
Collaborators: 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)
Conditions
(from sponsor)		 Diabetes Mellitus, Type 1
Related terms Diabetes Mellitus, Type 1
Enrollment 75,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov