TrialNet is an international consortium of clinical research centers that aim to accelerate the path of discovery to approaches to prevent or delay the onset of type 1 diabetes (T1D). TrialNet's current challenge is increasing efficacy and cost-effectiveness of subject recruitment and follow-up, and subsequent participation in prevention trials. In addition, effective T1D research requires a collaborative environment among investigators and with funding agencies, while promoting interest in T1D research among junior investigators, and engaging the larger T1D research community productively. We propose to establish a Texas Children's Hospital/Baylor College of Medicine (TCH/BCM) TrialNet Clinical Center that includes TCH/BCM in Houston with BCM Children's Hospital in San Antonio as Affiliate. Our program will provide TrialNet access to an extraordinary large pool of candidates by encompassing the two largest cities in Texas into a single Clinical Center. Efficacy and cost -effectiveness will be enhanced by utilizing TCH/BCM widespread health care geographical structure ( six TCH/BCM sites, a community health center, a network of 48 integrated pediatric offices, and BCM Children's Hospital in San Antonio, Texas) to minimize subject travel. Our program will facilitate TrialNet access to study populations of high T1D research interest, such as racial/ethnic minorities, newborns and pregnant women. We are committed to active collaboration with TrialNet, and NIDDK and its partners to develop and conduct studies aiming to prevent or delay T1D, or improve beta-cell function in T1D patients, by capitalizing on strong PI, co- investigator and institutional track records of productive collaboration in T1D research. Further, we have assembled an outstanding team of co-investigators from different backgrounds with a shared interest in T1D research collaboration. Our program will promote interest in T1D research among junior investigators by establishing an innovative TrialNet Junior Investigator with research funds through a TrialNet Junior Investigator Award, access to T1D research mentoring by TCH/BCM TrialNet co-investigators, and an active role in other TrialNet site activities, including participant recruitment and follow -up. Finally, we plan to develop a strong partnership among all parties involved in T1D prevention research, by creating a novel TrialNet Research Group that will engage TrialNet investigators, study participants, T1D patients, their families and T1D care providers as active participants in T1D research. The larger T1D community will be further reached out through diabetes camp, T1D local organizations, and a novel TrialNet Newspage. The robust program outlined above, the PI's demonstrated expertise on the etiology and pathogenesis of T1D, her track record of productive collaboration with multicenter T1D studies, her experience as PI of an active TrialNet center, TCH/BCM institutional commitment to TrialNet, and excellent research environment anticipate the success of a TCH/BCM Houston-San Antonio TrialNet Clinical Center.

Public Health Relevance

Type 1 diabetes (T1D), which is the most common form of childhood diabetes, is a life-long condition that requires parenteral insulin to avoid death, may lead to severe acute and chronic complications, and causes annual direct medical costs estimated in $6,000-10,000 million in the United States. With this RFA, TrialNet, an international consortium of clinical research centers that aim to accelerate the path of discovery to approaches to prevent or delay the onset of T1D, seeks to increase efficacy and cost-effectiveness of subject recruitment, follow-up, and subsequent participation in prevention trials. We propose to establish a Texas Children's Hospital/Baylor College of Medicine (TCH/BCM) TrialNet Clinical Center that includes TCH/BCM in Houston with BCM Children's Hospital in San Antonio as Affiliate and is able to provide TrialNet cost-effective access to an extraordinary larg pool of candidates by encompassing the two largest cities in Texas and utilizing the uniquely widespread TCH/BCM health care geographical structure;promote efficient T1D research by implementing a program that fosters collaboration among investigators, TrialNet and NIH;interest promising junior investigators in T1D research;and engage the larger T1D research community.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01DK103180-01
Application #
8775106
Study Section
Special Emphasis Panel (ZDK1-GRB-J (M2))
Program Officer
Leschek, Ellen W
Project Start
2014-08-01
Project End
2017-04-30
Budget Start
2014-08-01
Budget End
2015-04-30
Support Year
1
Fiscal Year
2014
Total Cost
$310,660
Indirect Cost
$105,404
Name
Baylor College of Medicine
Department
Pediatrics
Type
Schools of Medicine
DUNS #
051113330
City
Houston
State
TX
Country
United States
Zip Code
77030
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

Showing the most recent 10 out of 11 publications