Management of Pediatric Type 2 Diabetes Mellitus

描述（由申请人提供）： 近年来，儿童2型糖尿病（T2 DM）的病例越来越多， 已经变得很明显，这一现象被认为与广泛的 肥胖、体力活动减少和其他因素。增长率 儿童糖尿病代表了一种令人不安的趋势， 对社会未来医疗保健成本的影响。目前没有 广泛接受的临床建议，用于筛查或管理这种 儿童人群的情况。一个项目正在由 NIH通过实施干预措施来解决这一新出现的健康问题 试验以确定儿童T2 DM的适当治疗。孩子们？S 费城医院（CHOP）拟作为临床研究中心。费城是 美国城市的代表，并有很大比例的非洲裔美国人 和西班牙裔高危少数族裔CHOP的糖尿病护理中心（DCC） 目前跟踪了1100多名糖尿病儿童，诊断出30例新病例。 每年的T2 DM鉴于大多数T2 DM儿童患有 肥胖，并由此产生胰岛素抵抗，我们假设，改善 外周胰岛素敏感性将是最有效的治疗方法， 葡萄糖控制和维持胰岛素分泌。这样做的目的是 建议：1）评价儿童2型糖尿病的血糖控制 接受噻唑烷二酮、双胍或 磺脲类药物的前瞻性双盲随机试验。2)评价 次要结局指标包括胰岛素分泌功能、胰岛素 随着时间的推移，葡萄糖耐量和身体成分的敏感性， 治疗干预、血糖控制和心理社会功能。3)到 评价儿科患者2种口服药物联合治疗的血糖控制效果 已证实血糖控制不佳（血红蛋白）的T2 DM受试者 A1 c>6.5）在单一口服药物6个月后; 4）建立和维持 与卫生保健提供者、卫生保健系统、 和费城的社区机构，以支持有效实施 生活方式的改变对儿童T2 DM的管理至关重要。（最后5） 评估本地网络对生活方式改变的影响， 具体病人？随着时间的推移，如体重和BMI，心理 功能、饮食和身体健康。目标1在6个月后完成， 单一疗法。随后，患者随访5年。实现 为了实现这些目标，CHOP将利用其在DCC内的现有资源， 营养科和精神病学系。新的和现有的伙伴关系 将与费城社区的成员一起锻造和加强， 改变生活方式。

DESCRIPTION (provided by applicant): Recently, an increasing number of cases of type 2 diabetes (T2DM) in children have become evident, a phenomenon which is thought to be related to widespread obesity, decreased physical activity, and other factors. The rising rates of diabetes among children represent a disturbing trend with significant implications for future health care costs to society. Currently, there are no widely accepted clinical recommendations for screening or managing this condition in the pediatric population. A program is being established by the NIH to address this emerging health problem by implementing an intervention trial to identify appropriate treatment of childhood T2DM. The Children?s Hospital of Philadelphia (CHOP) proposes to be a clinical site. Philadelphia is representative of urban America and has a large proportion of African-American and Hispanic high-risk minorities. The Diabetes Care Center (DCC) at CHOP currently follows over 1100 children with diabetes and diagnoses 30 new cases per year of T2DM. Given that the majority of children with T2DM suffer from obesity, with resultant insulin resistance, we hypothesize that improvement of peripheral insulin sensitivity will be the most effective treatment, both for glucose control and for the preservation of insulin secretion. The aims of this proposal are: 1) To evaluate glucose control of pediatric Type 2 diabetes patients on monotherapy with either a thiazolidinedione, a biguanide, or a sulfonylurea in a prospective double blind randomized trial. 2) To evaluate secondary outcome measures including insulin secretory function, insulin sensitivity glucose tolerance and body composition over time, in relation to treatment interventions, glucose control, and psychosocial functioning. 3) To evaluate glucose control on combination therapy with 2 oral agents in pediatric subjects with T2DM who have demonstrated inadequate glucose control (hemoglobin A1c>6.5) after 6 months on a single oral agent; 4) To establish and sustain a local network of partnerships with health care providers, health care systems, and community agencies in Philadelphia to support effective implementation of lifestyle changes critical to the management of childhood T2DM. and finally 5) To evaluates the impact of the local network on lifestyle modification on specific patient?s outcomes over time such as weight and BMI, psychological function, diet, and physical fitness. Aim 1 is completed after 6 months of the monotherapy. Subsequently, the patients are followed for 5 years. To achieve these aims, CHOP will build upon its existing resources within the DCC, the Nutrition Section, and Department of Psychiatry. New and existing partnerships will be forged and reinforced with members of the Philadelphia community to implement lifestyle changes.