In Response to RFA DK-08-011, Vanderbilt University, a TrialNet Major Affiliate since 2006, proposes to become a Clinical Center. William E. Russell, MD, TrialNet PI, will continue in that role. He is joined by James W. Thomas MD, as the Co-Investigator. Salient points of this proposal: (Vanderbilt became an active Major Affiliate (MA) of TrialNet in October, 2006, 28 months ago. With the modest resources of a MA we have recruited 591 subjects from 12 states into the Natural History Study;enrolled 2 subjects into the Oral Insulin Prevention Trial, and four subjects into the CTLA4-lg study. We are the only MA to engage in this intervention study. We have also recruited 433 subjects from 51 families into the T1 Diabetes Genetics Consortium, making us the leading T1DGC recruitment site internationally. (We document an strong institutional support for the goals and activities of TrialNet, including: a commitment by Dr. Jonathan Gitlin, Chair of Pediatrics to fund an additional 1.0 FTE of TrialNet study coordinator;the strong endorsement of Dr. Gordon Bernard Director of the CTSA offering the full services of the CRCs;and a commitment by Dr. Alvin Powers to expand dedicated space in the VEDC, provide 0.5 FTE of administrative support, and the full resources of the Vanderbilt Diabetes Center for TrialNet. (The investigators are highly experienced and well-suited to carrying out the aims of a TrialNet Clinical Center. With the input of a Vanderbilt TrialNet Scientific Advisory Committee, they propose a diabetes intervention trial """"""""Combined inflammatory blockade and oral tolerance for intervention in T1D."""""""" (New strategies and alliances are proposed to facilitate recruitment to TrialNet studies at the level of a Clinical Center. Among them are partnerships with the TN Department of Healt and other instutitions with a far reach into our region. A Remote Recruitment Program and possible Mibile Clinical Research Unit are proposed to take our screening activities far beyond middle TN. (A TrialNet Community Advisory Board has been established to secure input regarding screening and outreach strategies from a variety of diabetes stakeholders in our region.

Public Health Relevance

Type 1 diabetes results from immune damage to the body's insulin producing, beta cells. Type 1 diabetes prevention requires identification of individuals with a predisposition to diabetes-related autoimmunity and the use of strategies to allow the patient's immune system to remain tolerant of proteins in the beta cells. Type 1 Diabetes TrialNet is a consortium of sites aimed at the prevention or amelioration of type 1 diabetes. Vanderbilt University would be highly honored to continue to participate in TrialNet as a Clinical Center.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZDK1-GRB-R (O1))
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Leschek, Ellen W
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Vanderbilt University Medical Center
Schools of Medicine
United States
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Ismail, Heba M; Xu, Ping; Libman, Ingrid M et al. (2018) The shape of the glucose concentration curve during an oral glucose tolerance test predicts risk for type 1 diabetes. Diabetologia 61:84-92
Culina, Slobodan; Lalanne, Ana Ines; Afonso, Georgia et al. (2018) Islet-reactive CD8+ T cell frequencies in the pancreas, but not in blood, distinguish type 1 diabetic patients from healthy donors. Sci Immunol 3:
Vecchio, Federica; Lo Buono, Nicola; Stabilini, Angela et al. (2018) Abnormal neutrophil signature in the blood and pancreas of presymptomatic and symptomatic type 1 diabetes. JCI Insight 3:
Redondo, Maria J; Steck, Andrea K; Sosenko, Jay et al. (2018) Transcription Factor 7-Like 2 (TCF7L2) Gene Polymorphism and Progression From Single to Multiple Autoantibody Positivity in Individuals at Risk for Type 1 Diabetes. Diabetes Care 41:2480-2486
Sanda, Srinath; Type 1 Diabetes TrialNet Study Group (2018) Increasing ICA512 autoantibody titers predict development of abnormal oral glucose tolerance tests. Pediatr Diabetes 19:271-276
Yeo, Lorraine; Woodwyk, Alyssa; Sood, Sanjana et al. (2018) Autoreactive T effector memory differentiation mirrors ? cell function in type 1 diabetes. J Clin Invest 128:3460-3474
Redondo, Maria J; Geyer, Susan; Steck, Andrea K et al. (2018) A Type 1 Diabetes Genetic Risk Score Predicts Progression of Islet Autoimmunity and Development of Type 1 Diabetes in Individuals at Risk. Diabetes Care 41:1887-1894
Greenbaum, Carla J; Speake, Cate; Krischer, Jeffrey et al. (2018) Strength in Numbers: Opportunities for Enhancing the Development of Effective Treatments for Type 1 Diabetes-The TrialNet Experience. Diabetes 67:1216-1225
Haller, Michael J; Schatz, Desmond A; Skyler, Jay S et al. (2018) Low-Dose Anti-Thymocyte Globulin (ATG) Preserves ?-Cell Function and Improves HbA1c in New-Onset Type 1 Diabetes. Diabetes Care 41:1917-1925
Redondo, Maria J; Geyer, Susan; Steck, Andrea K et al. (2018) TCF7L2 Genetic Variants Contribute to Phenotypic Heterogeneity of Type 1 Diabetes. Diabetes Care 41:311-317

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