In recent years, type 2 diabetes has been recognized as increasingly common among children and adolescents and data from diabetes referral centers indicate that type 2 diabetes now accounts for approximately 40 percent of patients diagnosed with diabetes between the ages of 10-19 years. A number of large epidemiological studies are currently underway to address the question of the true incidence of type 2 diabetes in the pediatric age population. However, despite this increasing incidence of type 2 diabetes among children and adolescents, there have been no large published studies examining the efficacy of potential treatment interventions. Rather, pediatric diabetologists have had to rely on treatment approaches based on the understanding of the pathophysiology of type 2 diabetes, and the results from treatment studies in adult patients. However, the relevance of adult studies to the treatment of type 2 diabetes in adolescents and children is unclear. This proposal aims to address the lack of such studies. Our intent is to participate in a multi-center, randomized, clinical trial to assess the efficacy and safety of potential treatment options for this disorder. We propose a four-arm trial, where participants are randomized to one of the following initial interventions: 1) metformin; 2) intensive lifestyle intervention to promote weight loss and alter diet, physical activity; and behavior patterns; 3) intensive lifestyle intervention plus metformin; 4) insulin. We also propose an approach for stepped-care for patients failing to meet minimum goals for glycemic control in their initial assigned treatment arm. This four-year study will assess the relative efficacy and safety of each of the experimental interventions, examining the primary outcomes of glycemic control and changes in insulin sensitivity and secretion. Associated secondary outcomes will include effects of treatment alternatives on body composition, cardiovascular fitness, cardiovascular risk factors, incidence of diabetes-related complications, as well as patient quality of life. It is anticipated that this trial will provide critical information to guide practitioners in the effective care of these patients, as well as establishing the infrastructure for an ongoing consortium of centers interested in the coordinated study of pediatric type 2 diabetes.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01DK061242-01
Application #
6447703
Study Section
Special Emphasis Panel (ZDK1-GRB-B (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
2001
Total Cost
$500,000
Indirect Cost
Name
University of Colorado Denver
Department
Pediatrics
Type
Schools of Medicine
DUNS #
065391526
City
Aurora
State
CO
Country
United States
Zip Code
80045
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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
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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
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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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
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
Kelsey, Megan M; Geffner, Mitchell E; Guandalini, Cynthia et al. (2016) Presentation and effectiveness of early treatment of type 2 diabetes in youth: lessons from the TODAY study. Pediatr Diabetes 17:212-21

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