Long-term objective: To find intervention therapies that can delay, prevent or reverse the development of type 1 diabetes (T1D).
Specific Aims : 1) BHT-3021 Proinsulin DNA vaccine treatment of recent onset type 1 diabetes subjects Research Design: Preliminary data in animals has shown that using a similar proinsulin DNA vaccine can reverse diabetes in hyperglycemic mice. Pre-clinical studies in mice and non-human primates have found no toxicity for this therapy and have suggested a dosing scheme which could be effective in human subjects with T1D. An ongoing phase 1 study has confirmed the safety of this treatment and has suggested potential efficacy in type 1 diabetes subjects >3 months from diagnosis who still have C-peptide present. The current trial will test 2 doses, 1 and 3 mg, given weekly for 12 doses in a new onset patient population. It will use established measures to determine the effect on C-peptide, HbA1c, total insulin use and other safety parameters. Mechanistic studies to look at effects on insulin and other autoantibodies, T cells and other immune effects will be performed to better understand the potential mechanism of effect. 2) Renewal of TrialNet Center Research Design: The Barbara Davis Center has been at the forefront of defining populations at risk for T1D and other autoimmune diseases and in recruiting patients for the TrialNet Natural History study as well as other TrialNet studies. The BDC TrialNet Center has helped to develop two of the first protocols, TN02 (MMF and DZB in new onset T1D), and TN06 (Nutritional Intervention to Prevent [NIP] Diabetes). Our proposal for renewal outlines our past efforts, current approaches and future goals to not only maintain our current level of productivity, but to increase productivity over the next funding cycle.
|Nathan, Brandon M; Boulware, David; Geyer, Susan et al. (2017) Dysglycemia and Index60 as Prediagnostic End Points for Type 1 Diabetes Prevention Trials. Diabetes Care 40:1494-1499|
|Bosi, Emanuele; Boulware, David C; Becker, Dorothy J et al. (2017) Impact of Age and Antibody Type on Progression From Single to Multiple Autoantibodies in Type 1 Diabetes Relatives. J Clin Endocrinol Metab 102:2881-2886|
|Sosenko, Jay M; Yu, Liping; Skyler, Jay S et al. (2017) The Use of Electrochemiluminescence Assays to Predict Autoantibody and Glycemic Progression Toward Type 1 Diabetes in Individuals with Single Autoantibodies. Diabetes Technol Ther 19:183-187|
|Hao, Wei; Wookwyk, Alyssa; Beam, Craig et al. (2017) Assessment of ? Cell Mass and Function by AIRmax and Intravenous Glucose in High-Risk Subjects for Type 1 Diabetes. J Clin Endocrinol Metab 102:4428-4434|
|Steck, Andrea K; Xu, Ping; Geyer, Susan et al. (2017) Can Non-HLA Single Nucleotide Polymorphisms Help Stratify Risk in TrialNet Relatives at Risk for Type 1 Diabetes? J Clin Endocrinol Metab 102:2873-2880|
|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|
|Yip, Linda; Fuhlbrigge, Rebecca; Atkinson, Mark A et al. (2017) Impact of blood collection and processing on peripheral blood gene expression profiling in type 1 diabetes. BMC Genomics 18:636|
|Ferrara, Christine T; Geyer, Susan M; Evans-Molina, Carmella et al. (2017) The Role of Age and Excess Body Mass Index in Progression to Type 1 Diabetes in At-Risk Adults. J Clin Endocrinol Metab 102:4596-4603|
|Ferrara, Christine Therese; Geyer, Susan Michelle; Liu, Yuk-Fun et al. (2017) Excess BMI in Childhood: A Modifiable Risk Factor for Type 1 Diabetes Development? Diabetes Care 40:698-701|
|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|
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