This is an application from the Joslin Diabetes Center/Children?s Hospital, a current Diabetes Prevention Trial-1 (DPT-1) Clinical Center to become a Clinical Center in the national diabetes trial network for Type 1 diabetes mellitus, the TrialNet. TrialNet, a national network of cooperative clinical research groups will consist of clinical centers and core support facilities. Its common goal will be to perform intervention studies to prevent, treat or ameliorate Type 1 diabetes mellitus in humans. TrialNet will also support natural history and genetic studies in the population screened or enrolled in specific studies aiming to achieve a better understanding of the etiology and pathogenesis of Type 1 diabetes and to develop strategies to prevent the disease. The Joslin Diabetes Center/Children?s Hospital proposed TrialNet Clinical Center includes expanded resources in experienced personnel, in addition to the expanded network of associated institutions to the collaborative effort led by the NIH. Our Clinical Center will have two major objectives: 1.) to complete the ongoing DPT-1 study; 2.) to participate in the design and implementation of existing and future pilot and expanded studies of new agents to prevent, treat or ameliorate Type 1 diabetes mellitus and also to participate and provide resources for genetic and natural history studies. The ongoing Diabetes Prevention Trial for Type 1 Diabetes (DPT-1) is testing, whether early intervention with parenteral or oral insulin in nondiabetic relatives of persons with Type 1 diabetes with increased risk for the disease can delay the clinical onset of Type 1 diabetes. The DPT-1 is currently funded through August 2001 and the TrialNet will be entrusted to carry on and complete the current protocol. Our Joslin/Children?s center is committed to contribute to future clinical studies in Type 1 diabetes mellitus. We also propose a novel interventional protocol, using insulin B-chain in incomplete Freund?s adjuvant in newly diagnosed Type 1 diabetes patients to test its preventive effect in beta cell function decline. The primary outcome measure is mixed meal stimulated C-peptide levels. Phase 1 part of the study is currently underway.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK061040-04
Application #
6798756
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
$349,446
Indirect Cost
Name
Joslin Diabetes Center
Department
Type
DUNS #
071723084
City
Boston
State
MA
Country
United States
Zip Code
02215
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
Pecorino, Basilio; Teodoro, Maria Cristina; Scollo, Paolo (2016) Polyglandular Autoimmune Syndrome in pregnancy: case report. Ital J Gynaecol Obstet 28:35-40
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
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
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

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