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TrialNet: Pathway to Prevention
Local Investigators: Tim Jones, Liz Davis
Study Staff: Julie Dart, Heather Roby; Adam Retterath
The overall objective of this multi-centre international study is to perform baseline and repeat assessments over time of the metabolic and immunologic status of individuals at risk for type 1 diabetes (T1D). This is in order to:(a) characterize their risk for developing T1D and identify subjects eligible for prevention trials, (b) describe the pathogenic evolution of T1D, and (c) increase the understanding of the pathogenic factors involved in the development of T1D.
The specific objectives of this study are:
- To determine the risk for the occurrence of T1D according to glucose tolerance tests, C-peptide levels, islet autoantibodies, HbA1c levels, markers of cell-mediated immunity, and genetic markers associated with T1D.
- To examine the accuracy of TrialNet measures in predicting future T1D.
- To characterize the progression of immunologic abnormalities in the development of T1D by serially studying islet autoantibodies and immune mechanistic studies.
- To characterize the progression of metabolic decompensation in the development of T1D by serially studying insulin, C-peptide, other islet hormones, HbA1c and glucose levels, and to identify immunologic and other factors associated with this decompensation.
- To determine the incidence of severe acute metabolic decompensation as the initial clinical presentation in individuals who have been identified as being at increased risk for T1D.
- To identify individuals who qualify for TrialNet T1D prevention trials.
- To accrue additional information about immunologic and metabolic factors related to the pathogenesis of T1D and validate new methods or tests that mark disease progression or response to therapy.
- To accrue additional information about genomic markers associated with risk for the development of T1D.
- For those participants who participated in the DPT-1 study, to examine associations of characteristics (e.g. demographics, immunologic, metabolic, etc.) assessed during the DPT-1 study with characteristics and outcomes assessed in TrialNet.
The primary outcome of this prospective cohort study is the development of diabetes as defined by the American Diabetes Association (ADA) based on glucose testing, or the presence of symptoms and unequivocal hyperglycaemia.
Participant eligibility: (1) Having a first degree relative (parent, sibling, child) with T1D, and aged 1 – 45 years; (2) having a second and third degree relative (nieces, nephews, aunts, uncles, grandparent, cousins, half-siblings) with T1D and aged 1 – 20 years.
Plain language summary: TrialNet is an international research study that screens relatives of people with a Type 1 diabetes for diabetes-related autoantibodies, Autoantibodies are markers that show that the immune system is switched on. The study is helping us to learn how type 1 diabetes develop and ways to delay and prevent it. If the screening test is positive for autoantibodies, it means there is an increased risk of developing diabetes. Participants who test positive are invited into the Monitoring stage, for follow-up visits. Depending on the results of these visits, we will continue to see them either semi-annually or annually, and they may be eligible to participate in a prevention study.
Children up to the age of 18 years are invited to be rescreened every year, as their autoantibody staus can change.
Funders: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Child Health and Human Development (NICHD), the National Center for Research Resources (NCRR), the Juvenile Diabetes Research Foundation International (JDRF), and the American Diabetes Association (ADA)