TREATMENT OPTIONS FOR TYPE 2 DIABETES IN ADOLESCENTS AND YOUTH (TODAY)

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。在过去的二十年中，患有2型糖尿病的儿童和青少年人数的增加被认为是一种流行病。到1999年，根据年龄和种族的不同，由2型糖尿病引起的糖尿病新病例的百分比在8-45%之间。儿童2型糖尿病的流行与超重或有超重风险的儿童数量的增加以及青少年身体活动模式的减少同时发生。此外，T2DM与青春期发病、T2DM阳性家族史以及代谢综合征（如黑皮病和多囊卵巢综合征（PCOS））等因素有很强的相关性。尽管儿童2型糖尿病的病例数量急剧增加，但尚未有大规模的研究调查儿童和青少年2型糖尿病的病理生理学、治疗和并发症。T2DM的潜在长期并发症和相关费用，特别是在如此年轻的年龄出现时，使得此类研究势在必行。因此，NIDDK/NIH正在赞助一项为期4年的多中心试验，青少年和青年2型糖尿病的治疗选择（TODAY）。丹佛儿童医院是这项全国治疗试验的12个地点之一。此外，当地PI （Zeitler博士）已被选为今日研究小组的主席。该试验将研究三个治疗组对血糖控制的安全性和有效性：(1)单用二甲双胍，(2)二甲双胍加强化生活方式干预，(3)二甲双胍加早期积极的噻唑烷二酮（TZD）药物治疗。除了治疗组对血糖控制的影响外，还将研究多个次要结局，以提供有关治疗组的作用机制和相关益处的信息。应该指出的是，Zeitler博士是本研究的组织、实施和监督的国家研究主席。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for 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.