The George Washington University Biostatistics Center proposes to serve as the Coordinating Center (CC) for the consortium of investigators being assembled by the NIDDK to conduct clinical trials of type 2 diabetes in children and adolescents. The consortium's objective is to develop and apply standardized methods, procedures, and measures to the conduct of (1) one multi-center, multi-arm clinical trial of treatment and (2) one or more primary prevention trials. Researchers and investigators from 6-10 clinical centers, the NIDDK, and the CC will comprise the consortium and collaborate under a cooperative agreement mechanism. This consortium will address the concern of health care researchers and providers over the steady and pernicious increase in detection of type 2 diabetes in youth both here and abroad. Knowing the consequences of type 2 diabetes in adults for micro- and macro-vascular disease progression, and knowing the role of adequate treatment and management, medical science seeks to broaden the scope of research to include treatment and prevention in this under-investigated and growing population of patients. The Steering Committee, composed of the principal investigators from the CC and each clinical center and the NIDDK project officer, will design and develop each of the clinical trials. The CC will provide centralized support and biostatistical consultation in: the development of protocols; manuals of procedures, data collection forms, and randomization procedures; implementation of a data management system including data quality assessment; interim analysis of protocol performance, patient safety, and treatment, efficacy; and final analysis for publication of results in collaboration with the clinical investigators. The CC will establish a secure encrypted and password protected web site for study staff to enhance development, distribution, and use of study documents. We have assembled a team of coordinating center staff and consultants with established credentials and experience in major diabetes research efforts, including the Diabetes Control and Complications Trial and the Diabetes Prevention Program.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01DK061230-06S3
Application #
7497282
Study Section
Special Emphasis Panel (ZDK1-GRB-B (O2))
Program Officer
Linder, Barbara
Project Start
2001-09-30
Project End
2009-02-28
Budget Start
2007-03-01
Budget End
2008-02-29
Support Year
6
Fiscal Year
2007
Total Cost
$2,000,000
Indirect Cost
Name
George Washington University
Department
Biostatistics & Other Math Sci
Type
Schools of Arts and Sciences
DUNS #
043990498
City
Washington
State
DC
Country
United States
Zip Code
20052
Kleinberger, Jeffrey W; Copeland, Kenneth C; Gandica, Rachelle G et al. (2018) Monogenic diabetes in overweight and obese youth diagnosed with type 2 diabetes: the TODAY clinical trial. Genet Med 20:583-590
Berkowitz, Robert I; Marcus, Marsha D; Anderson, Barbara J et al. (2018) Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial. Pediatr Diabetes 19:191-198
Arslanian, Silva; El Ghormli, Laure; Kim, Joon Young et al. (2018) The Shape of the Glucose Response Curve During an Oral Glucose Tolerance Test: Forerunner of Heightened Glycemic Failure Rates and Accelerated Decline in ?-Cell Function in TODAY. Diabetes Care :
Bjornstad, Petter; Nehus, Edward; El Ghormli, Laure et al. (2018) Insulin Sensitivity and Diabetic Kidney Disease in Children and Adolescents With Type 2 Diabetes: An Observational Analysis of Data From the TODAY Clinical Trial. Am J Kidney Dis 71:65-74
Kriska, Andrea; El Ghormli, Laure; Copeland, Kenneth C et al. (2018) Impact of lifestyle behavior change on glycemic control in youth with type 2 diabetes. Pediatr Diabetes 19:36-44
Venditti, E M; Tan, K; Chang, N et al. (2018) Barriers and strategies for oral medication adherence among children and adolescents with Type 2 diabetes. Diabetes Res Clin Pract 139:24-31
Gidding, Samuel S; Bacha, Fida; Bjornstad, Petter et al. (2018) Cardiac Biomarkers in Youth with Type 2 Diabetes Mellitus: Results from the TODAY Study. J Pediatr 192:86-92.e5
Levitt Katz, Lorraine E; Bacha, Fida; Gidding, Samuel S et al. (2018) Lipid Profiles, Inflammatory Markers, and Insulin Therapy in Youth with Type 2 Diabetes. J Pediatr 196:208-216.e2
Todd, Jennifer N; Srinivasan, Shylaja; Pollin, Toni I (2018) Advances in the Genetics of Youth-Onset Type 2 Diabetes. Curr Diab Rep 18:57
Kelsey, Megan M; Braffett, Barbara H; Geffner, Mitchell E et al. (2018) Menstrual Dysfunction in Girls From the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study. J Clin Endocrinol Metab 103:2309-2318

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