The long-term objective of this proposal is the prevention of autoimmune mediated Type 1 diabetes mellitus (T1DM). T1DM is a serious life limiting disease that strikes predominantly in children and adolescents. The TrialNet clinical research network, the focus of the proposal, designs and conducts studies aimed at preventing or delaying the onset or progression of type 1 diabetes, both highly relevant public health goals. Many promising interventions must be tested in a safe and efficient manner in order to achieve this goal. A well-organized cooperative network of capable institutes, the Type 1 Diabetes TrialNet group, has greatly facilitated the prompt completion of many clinical trials needed to test these potential interventions. The application responds to the RFA to select the clinical centers that will form TrialNet for the next 5 years. The goal of this proposal is to both continu and improve the infrastructure essential to completing the current TrialNet studies seeking to prevent T1DM in subjects at risk for T1DM, and to preserve endogenous insulin secretion in subjects with new onset T1DM. This application reviews Stanford's five-year experience as a successful and productive TrialNet national center in California and highlights Stanford's plans for extending and improving recruitment and retention activities for the next 5 years. These plans include both completing the current TrialNet studies and implementing the expected upcoming trials. The Stanford University TrialNet Center aggressively recruits relatives into the Pathway to Prevention study both at Stanford University and across our affiliate network in California, Nevada, and Arizona. This study is the path to all of TrialNet's T1DM prevention trials. Our center has been very successful at transitioning eligible subjects into TrialNet's randomized prevention trials. Long-term retention of Stanford's subjects in all studies continues to be outstanding. The Stanford University TrialNet Center has enrolled subjects in four Mechanistic trials, six trials designed to preserve endogenous insulin product at the onset of T1DM, and five T1DM prevention trials. Stanford is particularly proud of its role in conceiving and leading the Effects of Metabolic at Onset of Diabetes on Progression of T1DM to its successful conclusion. The Stanford University TrialNet Center is well positioned to continue to support TrialNet's ultimate raison d'?tre, the prevention of T1DM.

Public Health Relevance

Type 1 diabetes mellitus is a serious, chronic, life limiting disease that strikes predominantly in children and adolescents. The TrialNet clinical research network, the focus of the proposal, designs and conducts studies aimed at preventing or delaying the onset or progression of type 1 diabetes, both highly relevant public health goals.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01DK061042-13
Application #
8776563
Study Section
Special Emphasis Panel (ZDK1-GRB-J (M2))
Program Officer
Leschek, Ellen W
Project Start
2001-09-29
Project End
2019-04-30
Budget Start
2014-08-15
Budget End
2015-04-30
Support Year
13
Fiscal Year
2014
Total Cost
$493,589
Indirect Cost
$186,057
Name
Stanford University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
009214214
City
Stanford
State
CA
Country
United States
Zip Code
94305
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
Sosenko, Jay M (2016) Staging the progression to type 1 diabetes with prediagnostic markers. Curr Opin Endocrinol Diabetes Obes 23:297-305

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