Treatment Alternatives in Pediatric Type 2 Diabetes

描述（由申请人提供）： 近年来，2型糖尿病已被公认为越来越常见 糖尿病转诊中心的数据表明， 现在2型糖尿病患者中有40% 10-19岁之间被诊断为糖尿病。多家大型 目前正在进行流行病学研究， 2型糖尿病在儿童年龄人群中的真实发病率。然而，在这方面， 尽管儿童中2型糖尿病的发病率增加， 对于青少年，尚未有大型已发表的研究检查其疗效 潜在的治疗干预措施。相反，儿科糖尿病学家 依靠基于对疾病的理解的治疗方法， 2型糖尿病的病理生理学，以及 成人患者。然而，成人研究与治疗的相关性 2型糖尿病在青少年和儿童中的发病率尚不清楚。这项建议旨在 解决缺乏此类研究的问题。我们的目的是参加一个 多中心、随机、临床试验，以评估 这种疾病的潜在治疗选择。我们建议进行四臂试验 其中参与者被随机分配到以下初始之一 干预措施：1）二甲双胍; 2）强化生活方式干预， 减肥和改变饮食，身体活动;和行为模式; 3） 强化生活方式干预加二甲双胍; 4）胰岛素。我们也提出了一个 对未能达到最低目标的患者的分步护理方法， 在最初分配的治疗组中， 将评估每种实验药物的相对有效性和安全性， 干预措施，检查血糖控制和变化的主要结果 胰岛素敏感性和分泌。相关次要结局将 包括替代治疗对身体组成、心血管 健身，心血管危险因素，糖尿病相关发病率 并发症，以及患者的生活质量。预计这一 试验将提供关键信息，以指导从业人员在有效的 照顾这些病人，以及建立基础设施， 正在进行的对儿科协调研究感兴趣的中心联盟 2型糖尿病

DESCRIPTION (provided by applicant): 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.