This application for the treatment of type 2 diabetes mellitus in children (T2DM) is from a strong cadre of investigators from Children?s Hospital of Pittsburgh and the University of Pittsburgh. These investigators bring together a long-standing tradition of expertise in 1) childhood diabetes (Drs. Arslanian and Becker), 2) in investigating insulin resistance and secretion in children (Dr. Arslanian, PI), 3) in behavioral medicine and lifestyle intervention for childhood obesity (Drs. Marcus and Vinditti), 4) in physical activity and lifestyle interventions (Drs. Kriska and Aaron), 5) in epidemiology of chronic disease and large intervention trials of obesity, type 2 diabetes and cardiovascular disease (Drs. Lewis Kuller, Kriska and Marcus), and 6) in recruiting for large intervention trials (Janet Bonk). Based on our collective strength, we believe that we can fully meet the goals for a clinical site for this multicenter trial of type 2 diabetes mellitus in children. The PI, Silva Arslanian, M.D., has been at the forefront of the """"""""emerging epidemic"""""""" of type 2 diabetes in children. She has been a consultant to the NIH, CDC, and the American Diabetes Association (ADA). She was one of the eight-member panel of experts who developed the ADA Consensus Position of type 2 Diabetes in Children and Adolescents. Her research in childhood insulin resistance and secretion has made important contributions to the understanding of risk factors for type 2 diabetes mellitus in children. In addition, there is a strong institutional infrastructure to support our application, including 1) the pediatric General Clinical Research Center (Director, Silva Arslanian, M.D.), 2) the Diabetes Center at Children?s Hospital of Pittsburgh, 3) the NIH-funded Obesity Nutrition Research Center (ONRC), (David Kelley, M.D., PI), 4) the Graduate School of Public Health, and lastly, 5) the multiple collaborations with different disciplines including national programs for disadvantaged youth. Finally, the K24 Award of the PI in patient-oriented research complements one of the objectives of this RFA which is to train and develop young clinician-scientists. Our proposal will investigate intervention strategies in youth with T2DM with the objective of delaying beta-cell deterioration and preserving beta-cell function. To this aim we propose to use a randomized clinical trial design with 3 arms: conventional care, behavioral lifestyle and risk management intervention, and behavioral lifestyle intervention combined with dual-agent insulin sensitizing therapy. Measures of beta-cell function and insulin resistance will be the primary outcome of interest. Urinary albumin excretion and carotid artery intima-media thickness will be the secondary outcomes of interest. We also propose that this RFA incorporate ancillary studies. A comprehensive approach to therapeutic interventions in children with type 2 diabetes mellitus will form the basis for prevention of adult morbidity and mortality starting early in childhood.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01DK061254-01S1
Application #
6666101
Study Section
Special Emphasis Panel (ZDK1 (O1))
Program Officer
Linder, Barbara
Project Start
2001-09-30
Project End
2009-02-28
Budget Start
2001-09-30
Budget End
2003-02-28
Support Year
1
Fiscal Year
2002
Total Cost
$900,000
Indirect Cost
Name
Children's Hosp Pittsburgh/Upmc Health Sys
Department
Type
DUNS #
044304145
City
Pittsburgh
State
PA
Country
United States
Zip Code
15224
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
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 :
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
Arslanian, Silva; El Ghormli, Laure; Bacha, Fida et al. (2017) Adiponectin, Insulin Sensitivity, ?-Cell Function, and Racial/Ethnic Disparity in Treatment Failure Rates in TODAY. Diabetes Care 40:85-93
Rockette-Wagner, Bonny; Storti, Kristi L; Edelstein, Sharon et al. (2017) Measuring Physical Activity and Sedentary Behavior in Youth with Type 2 Diabetes. Child Obes 13:72-77
Chadwick, Jennifer Q; Van Buren, Dorothy J; Morales, Elisa et al. (2017) Structure to utilize interventionists' implementation experiences of a family-based behavioral weight management program to enhance the dissemination of the standardized intervention: The TODAY study. Clin Trials 14:406-412

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