Abstract

The University of Minnesota proposes to be designated as a Diabetes Type 1 TriaINet Clinical Center. The University of Minnesota has maintained a very productive and efficient clinical center for the Diabetes Prevention Trial 1 (DPT-1) in terms of recruitment and screening of subjects, staging, randomization and compliance with all aspects of protocol implementation. It is proposed that the extensive network of institutional affiliations and satellites for the DPT-1 be retained for TrialNet thus providing greater than 2,500 newly diagnosed Type 1 diabetic patients per year who may be considered for participation in the approved TriaINet protocols. This network and the proven team of investigators and coordinators will assure effective recruitment and compliance. We propose two protocols to be considered for therapeutic intervention utilizing p277, a heat shock protein-derived peptide, which has been proven in preliminary human trials to be effective in preventing the appearance of Type 1 diabetes in at-risk subjects and in improving/delaying/modifying the insulin dependency and endogenous C-peptide secretion in new onset Type 1 diabetic subjects.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK061036-04
Application #
6798752
Study Section
Special Emphasis Panel (ZDK1-GRB-C (O1))
Program Officer
Leschek, Ellen W
Project Start
2001-09-29
Project End
2008-06-30
Budget Start
2004-07-01
Budget End
2005-06-30
Support Year
4
Fiscal Year
2004
Total Cost
$296,369
Indirect Cost

  Institution

Name
University of Minnesota Twin Cities
Department
Pediatrics
Type
Schools of Medicine
DUNS #
555917996
City
Minneapolis
State
MN
Country
United States
Zip Code
55455

  Publications

Writing Committee for the Type 1 Diabetes TrialNet Oral Insulin Study Group; Krischer, Jeffrey P; Schatz, Desmond A et al. (2017) Effect of Oral Insulin on Prevention of Diabetes in Relatives of Patients With Type 1 Diabetes: A Randomized Clinical Trial. JAMA 318:1891-1902
Marwaha, A K; Panagiotopoulos, C; Biggs, C M et al. (2017) Pre-diagnostic genotyping identifies T1D subjects with impaired Treg IL-2 signaling and an elevated proportion of FOXP3+IL-17+ cells. Genes Immun 18:15-21
Cabrera, Susanne M; Wang, Xujing; Chen, Yi-Guang et al. (2016) Interleukin-1 antagonism moderates the inflammatory state associated with Type 1 diabetes during clinical trials conducted at disease onset. Eur J Immunol 46:1030-46
Sosenko, Jay M; Skyler, Jay S; Palmer, Jerry P et al. (2015) The development, validation, and utility of the Diabetes Prevention Trial-Type 1 Risk Score (DPTRS). Curr Diab Rep 15:49
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
Herold, Kevan C; Usmani-Brown, Sahar; Ghazi, Tara et al. (2015) ? cell death and dysfunction during type 1 diabetes development in at-risk individuals. J Clin Invest 125:1163-73
Bingley, Polly J; Rafkin, Lisa E; Matheson, Della et al. (2015) Use of Dried Capillary Blood Sampling for Islet Autoantibody Screening in Relatives: A Feasibility Study. Diabetes Technol Ther 17:867-71
Bollyky, Jennifer B; Xu, Ping; Butte, Atul J et al. (2015) Heterogeneity in recent-onset type 1 diabetes - a clinical trial perspective. Diabetes Metab Res Rev 31:588-94
Loechelt, Brett J; Green, Michael; Gottlieb, Peter A et al. (2015) Screening and Monitoring for Infectious Complications When Immunosuppressive Agents Are Studied in the Treatment of Autoimmune Disorders. J Pediatric Infect Dis Soc 4:198-204
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

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