TrialNet Pathway to Prevention of T1D

Recruiting now

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT00097292

Run by

University of South Florida

People needed

75000

Starts

2004-02-01

Expected to finish

2030-07-31

Last updated by the study team

2025-07-01

Who can join

Age: 2 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Childrens Hospital of Orange County — Orange, California, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• Stanford University Medical Center — Stanford, California, United States (enrolling)
• Barbara Davis Center for Childhood Diabetes — Denver, Colorado, United States (enrolling)
• Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• Emory Children's Center — Atlanta, Georgia, United States (enrolling)
• Riley Hospital for Children, Indiana University — Indianapolis, Indiana, United States (enrolling)
• Joslin Diabetes Center — Boston, Massachusetts, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• The Children's Mercy Hospital — Kansas City, Missouri, United States (enrolling)
• Columbia University — New York, New York, United States (enrolling)
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States (enrolling)
• Vanderbilt University — Nashville, Tennessee, United States (enrolling)
• University of Texas Medical Center at Dallas — Dallas, Texas, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)
• Benaroya Research Institute — Seattle, Washington, United States (enrolling)
• Walter and Eliza Hall Institute — Parkville, Victoria, Australia (enrolling)
• The Hospital for Sick Children — Toronto, Ontario, Canada (enrolling)
• University of Turku — Turku, Finland
• Vita-Salute San Raffaele University — Milan, Italy
• University of Bristol — Bristol, United Kingdom

Full record on ClinicalTrials.gov

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