This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Over the last two decades, the increase in the number children and adolescents with T2DM has been labeled an epidemic. By 1999, the percent of new cases of diabetes due to T2DM was between 8-45%, depending on age and ethnicity. The epidemic of pediatric T2DM is coincident with the rise in the number of children who are overweight or at risk for overweight and with a decrease in the physical activity pattern of youth. In addition, there has been a strong association between T2DM and the onset of puberty, a positive family history of T2DM, and elements of the metabolic syndrome, such as acanthosis nigricans and polycystic ovarian syndrome (PCOS). Despite the dramatic increase in the number of cases of T2DM in childhood, there have been no large-scale studies investigating the pathopysiology, treatment, and complications of T2DM in children and youth. The potential long-term complications and costs associated with T2DM, particularly when appearing at such a young age, make such studies imperative. Therefore, the NIDDK/NIH is sponsoring a 4-year Multi-center trial, Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY). The Children's Hospital of Denver is one of twelve sites included in this national treatment trial. In addition, the local PI (Dr. Zeitler) has been chosen as the Chair of the TODAY Study Group. The trial will study the safety and efficacy of three treatment arms on glycemic control: (1) metformin alone, (2) metformin plus an intensive lifestyle intervention, (3) metformin plus early aggressive pharmacologic therapy using a thiazolidinedione (TZD). In addition to the effect of the treatment arms on glycemic control, multiple secondary outcomes will be studied to provide information regarding mechanism of action and associated benefits of the treatment arms. It should be pointed out that Dr. Zeitler is the National Study Chair for the organization, conduct and oversight of this study.
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