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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00097292
Registration number
NCT00097292
Ethics application status
Date submitted
19/11/2004
Date registered
22/11/2004
Date last updated
21/12/2023
Titles & IDs
Public title
TrialNet Pathway to Prevention of T1D
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Scientific title
TrialNet Pathway to Prevention of T1D
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Secondary ID [1]
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UC4DK117009
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Secondary ID [2]
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NHStudy (IND)
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 1
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Annual Re-Testing/Annual Metabolic Monitoring - Participants will be monitored annually for risk of type 1 diabetes.
Semi-Annual Metabolic Monitoring - Participants will be monitored every six months for risk of type 1 diabetes
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Development of type 1 diabetes
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Assessment method [1]
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The primary outcome is the development of diabetes as defined by the American Diabetes Association (ADA) based on glucose testing, or the presence of symptoms and unequivocal hyperglycemia.
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Timepoint [1]
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Monitoring is provided once or twice annually depending on risk level
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Secondary outcome [1]
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Metabolic and Autoantibody Assessments
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Assessment method [1]
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Oral Glucose Tolerance Test (OGTT) HbA1c Autoantibodies: ICA, IA-2A, GAD65A, mIAA, ZnT8A
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Timepoint [1]
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Metabolic and Autoantibody assessments are provided once or twice annually depending on risk level
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Eligibility
Key inclusion criteria
- Individuals 2.5 to 45 years old who have an immediate family member with type 1
diabetes (such as a child, parent, or sibling)
- Individuals 2.5-20 years old who have an extended family member with type 1 diabetes
(such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
- Individuals 2.5-45 years old without a type 1 diabetes proband, who are known to have
1 or more islet antibody are eligible for screening if needed to determine eligibility
for a clinical trial to delay or prevent disease progression.
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Minimum age
30
Months
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Maximum age
45
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
To be eligible a person must not:
- Have diabetes already
- Have a previous history of being treated with insulin or oral diabetes medications.
- Currently be using systemic immunosuppressive agents (topical and inhaled agents are
acceptable)
- Have any known serious diseases
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2025
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Actual
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Sample size
Target
75000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Walter and Eliza Hall Institute - Parkville
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Recruitment postcode(s) [1]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Indiana
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Missouri
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Pennsylvania
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Tennessee
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Texas
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Washington
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Canada
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Ontario
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Finland
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Turku
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Italy
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Milan
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United Kingdom
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Bristol
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of South Florida
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Address
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Government body
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Name [1]
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Other collaborator category [2]
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Other
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American Diabetes Association
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Government body
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National Institute of Allergy and Infectious Diseases (NIAID)
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National Center for Research Resources (NCRR)
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00097292
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Trial related presentations / publications
Diabetes Prevention Trial--Type 1 Diabetes Study Group. Effects of insulin in relatives of patients with type 1 diabetes mellitus. N Engl J Med. 2002 May 30;346(22):1685-91. doi: 10.1056/NEJMoa012350.
Gale EA, Bingley PJ, Emmett CL, Collier T; European Nicotinamide Diabetes Intervention Trial (ENDIT) Group. European Nicotinamide Diabetes Intervention Trial (ENDIT): a randomised controlled trial of intervention before the onset of type 1 diabetes. Lancet. 2004 Mar 20;363(9413):925-31. doi: 10.1016/S0140-6736(04)15786-3.
Atkinson MA, Eisenbarth GS. Type 1 diabetes: new perspectives on disease pathogenesis and treatment. Lancet. 2001 Jul 21;358(9277):221-9. doi: 10.1016/S0140-6736(01)05415-0. Erratum In: Lancet. 2001 Sep 1;358(9283):766.
Verge CF, Gianani R, Kawasaki E, Yu L, Pietropaolo M, Jackson RA, Chase HP, Eisenbarth GS. Prediction of type I diabetes in first-degree relatives using a combination of insulin, GAD, and ICA512bdc/IA-2 autoantibodies. Diabetes. 1996 Jul;45(7):926-33. doi: 10.2337/diab.45.7.926.
Bingley PJ, Christie MR, Bonifacio E, Bonfanti R, Shattock M, Fonte MT, Bottazzo GF, Gale EA. Combined analysis of autoantibodies improves prediction of IDDM in islet cell antibody-positive relatives. Diabetes. 1994 Nov;43(11):1304-10. doi: 10.2337/diab.43.11.1304.
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Public notes
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Contacts
Principal investigator
Name
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Kevan Herold, M.D.
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Address
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Yale School of Medicine
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Contact person for public queries
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TrialNet Central Information Center general info
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Address
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Phone
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1-800-425-8361
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00097292
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