This application requests support for the continuing operations of the TrialNet Coordinating Center (TNCC) at the University of South Florida. The University of South Florida has served as the Coordinating Center for TrialNet since October, 2008. The primary objective of TrialNet is to prevent or delay initial onset and/or progression of type 1 diabetes (T1DM) by preserving insulin-producing beta cells in individuals at elevated risk and those who have been newly diagnosed with T1DM. To achieve this goal, TrialNet designs and implements prevention and interventional clinical trials intended to test treatments that may preserve remaining insulin secretion. The TNCC provides epidemiological, biostatistical, operational and administrative expertise and advice to the clinical centers, reference laboratories and the NIDDK which include the following tasks: 1) study-wide communications, procurement and dissemination of study materials, and related activities;2) data management and records maintenance;3) clinical site and central laboratories monitoring;4) data analyses;5) preparation of study reports and papers for publication;6) implementation of procedures to evaluate management, methodology, and cost-effectiveness of procedures utilized by the TNCC;and 7) periodic meetings.

Public Health Relevance

The goal of Type 1 Diabetes TrialNet is the identification of individuals at- risk for development of type 1 diabetes (T1DM). Identification of individuals at elevated risk of developing the disease will provide more information about risk factors, leading to a better understanding of disease pathogenesis. Enrolling at-risk individuals in intervention studies to test treatments intended to delay or prevent the onset of type 1 diabetes and enrolling newly diagnosed individuals in intervention studies to test treatments intended to preserve remaining insulin secretion may result in new strategies to prevent, delay or reverse T1DM. The TrialNet Coordinating Center maintains study protocols, provides project oversight, coordination, communication, statistical analyses and capability to collect longitudinal data and results of laboratory analyses of biological specimens from individuals at-risk for diabetes.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
High Impact Research and Research Infrastructure Cooperative Agreement Programs—Multi-Yr Funding (UC4)
Project #
1UC4DK097835-01
Application #
8447838
Study Section
Special Emphasis Panel (ZDK1-GRB-7 (O1))
Program Officer
Leschek, Ellen W
Project Start
2012-09-30
Project End
2017-06-30
Budget Start
2012-09-30
Budget End
2017-06-30
Support Year
1
Fiscal Year
2012
Total Cost
$44,999,998
Indirect Cost
$6,067,330
Name
University of South Florida
Department
Pediatrics
Type
Schools of Medicine
DUNS #
069687242
City
Tampa
State
FL
Country
United States
Zip Code
33612
Sosenko, Jay M (2016) Staging the progression to type 1 diabetes with prediagnostic markers. Curr Opin Endocrinol Diabetes Obes 23:297-305
Xu, Ping; Krischer, Jeffrey P; Type 1 Diabetes TrialNet Study Group (2016) Prognostic Classification Factors Associated With Development of Multiple Autoantibodies, Dysglycemia, and Type 1 Diabetes-A Recursive Partitioning Analysis. Diabetes Care 39:1036-44
Hao, Wei; Greenbaum, Carla J; Krischer, Jeffrey P et al. (2015) The Effect of DPT-1 Intravenous Insulin Infusion and Daily Subcutaneous Insulin on Endogenous Insulin Secretion and Postprandial Glucose Tolerance. Diabetes Care 38:891-6
Herold, Kevan C; Usmani-Brown, Sahar; Ghazi, Tara et al. (2015) β cell death and dysfunction during type 1 diabetes development in at-risk individuals. J Clin Invest 125:1163-73
Sosenko, Jay M; Skyler, Jay S; DiMeglio, Linda A et al. (2015) A new approach for diagnosing type 1 diabetes in autoantibody-positive individuals based on prediction and natural history. Diabetes Care 38:271-6
Chase, H Peter; Boulware, David; Rodriguez, Henry et al. (2015) Effect of docosahexaenoic acid supplementation on inflammatory cytokine levels in infants at high genetic risk for type 1 diabetes. Pediatr Diabetes 16:271-9
Sosenko, Jay M; Skyler, Jay S; Beam, Craig A et al. (2015) The development and utility of a novel scale that quantifies the glycemic progression toward type 1 diabetes over 6 months. Diabetes Care 38:940-2
Miao, Dongmei; Steck, Andrea K; Zhang, Li et al. (2015) Electrochemiluminescence assays for insulin and glutamic acid decarboxylase autoantibodies improve prediction of type 1 diabetes risk. Diabetes Technol Ther 17:119-27
Insel, Richard A; Dunne, Jessica L; Atkinson, Mark A et al. (2015) Staging presymptomatic type 1 diabetes: a scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care 38:1964-74
Ismail, Heba M; White, Kama S; Krischer, Jeffrey P et al. (2015) First test effect in intravenous glucose tolerance testing. Pediatr Diabetes 16:129-37

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