The Berrie Center is uniquely situated to contribute to the design and conduct of T1DM trials as part of TrialNet. The Berrie Center combines multi-disciplinary clinical care for patients with diabetes and clinical and basic research programs in diabetes all in one facility. The close geographic proximity of clinicians, scientists, patients, and clinical research subjects facilitates excellent and seamless collaboration and cross-fertilization and provides a unique and vibrant research environment that fosters translational research. The Berrie Center is the only multi- disciplinary diabetes center in New York City, with a large and growing referral base and a staff and patient population interested in type 1 diabetes research. The Berrie Center has been a very productive and contributing member of the TrialNet group. Although we've been a Major Affiliate rather than a Clinical Center for the past several years, our level of participation in the intervention trials has been at the level of a Clinical Center, randomizing 6-7% of total subjects into the treatment and prevention trials. In addition, we have supervised a productive Affiliate Network of 12 TrialNet affiliate sites. Therapeutic targeting of the SYK protein tyrosine kinase is a promising area of clinical investigation. Pre-clinical studies have established that an orally available small molecule syk inhibitor, R788, can prevent collagen-induced arthritis and prevent/treat NZB/NZW lupus nephritis. Phase II clinical studies in rheumatoid arthritis and ITP have demonstrated encouraging efficacy and manageable toxicities and continued evaluation in these diseases as well as in SLE are on-going. We have demonstrated the ability of R788 to inhibit cross-presentation and T1DM development in NOD mice, providing proof-of principal for this approach in T1DM. As a key component of this TrialNet application, we propose an intervention study to investigate its efficacy in human subjects with new-onset T1DM (onset within 100 days of randomization).

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK085504-05
Application #
8468695
Study Section
Special Emphasis Panel (ZDK1-GRB-R (O1))
Program Officer
Leschek, Ellen W
Project Start
2009-09-30
Project End
2014-04-30
Budget Start
2013-05-01
Budget End
2014-04-30
Support Year
5
Fiscal Year
2013
Total Cost
$234,808
Indirect Cost
$96,620
Name
Columbia University (N.Y.)
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
621889815
City
New York
State
NY
Country
United States
Zip Code
10032
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
Fouts, Alexandra; Pyle, Laura; Yu, Liping et al. (2016) Do Electrochemiluminescence Assays Improve Prediction of Time to Type 1 Diabetes in Autoantibody-Positive TrialNet Subjects? Diabetes Care 39:1738-44
Narsale, Aditi; Moya, Rosita; Robertson, Hannah Kathryn et al. (2016) Data on correlations between T cell subset frequencies and length of partial remission in type 1 diabetes. Data Brief 8:1348-51
Bundy, Brian N; Krischer, Jeffrey P; Type 1 Diabetes TrialNet Study Group (2016) A model-based approach to sample size estimation in recent onset type 1 diabetes. Diabetes Metab Res Rev 32:827-834
Pugliese, Alberto; Boulware, David; Yu, Liping et al. (2016) HLA-DRB1*15:01-DQA1*01:02-DQB1*06:02 Haplotype Protects Autoantibody-Positive Relatives From Type 1 Diabetes Throughout the Stages of Disease Progression. Diabetes 65:1109-19
Hao, Wei; Gitelman, Steven; DiMeglio, Linda A et al. (2016) Fall in C-Peptide During First 4 Years From Diagnosis of Type 1 Diabetes: Variable Relation to Age, HbA1c, and Insulin Dose. Diabetes Care 39:1664-70
Moya, Rosita; Robertson, Hannah Kathryn; Payne, Dawson et al. (2016) A pilot study showing associations between frequency of CD4(+) memory cell subsets at diagnosis and duration of partial remission in type 1 diabetes. Clin Immunol 166-167:72-80
Sims, Emily K; Chaudhry, Zunaira; Watkins, Renecia et al. (2016) Elevations in the Fasting Serum Proinsulin-to-C-Peptide Ratio Precede the Onset of Type 1 Diabetes. Diabetes Care 39:1519-26
Sosenko, Jay M (2016) Staging the progression to type 1 diabetes with prediagnostic markers. Curr Opin Endocrinol Diabetes Obes 23:297-305
Meah, Farah A; DiMeglio, Linda A; Greenbaum, Carla J et al. (2016) The relationship between BMI and insulin resistance and progression from single to multiple autoantibody positivity and type 1 diabetes among TrialNet Pathway to Prevention participants. Diabetologia 59:1186-95

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