DIABETES PREVENTION TRIAL-IDDM (DPT-1)

糖尿病预防试验-IDDM (DPT-1)

• 批准号: 6176234
• 负责人: JAY S SKYLER
• 金额: $ 262.93万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-09-30 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6176234
• 关键词: autoantibody; clinical trials; cooperative study; data collection; diabetes mellitus genetics; disease /disorder prevention /control; genetic markers; human subject; insulin dependent diabetes mellitus; oral tolerance; pancreatic islet function; prediabetic state

Type I or insulin-Dependent Diabetes Mellitus (IDDM) arises in genetically predisposed individuals as consequence of immune mediated destruction of the pancreatic islet insulin secreting beta-cells. The onset of clinical symptoms of diabetes represents the end point of a chronic progressive decline in beta-cell function, and occurs when the majority of beta-cells have been lost. Since type 1 diabetes develops insidiously from an ongoing, immune-mediated destructive process, and it can be predicted with some degree of accuracy, then it is possible that intervention at a point in this long prodromal period would prevent the initiation or perpetuation of beta-cell destruction. A number of potential intervention strategies exist that may slow the course or prevent the development of type I diabetes, and/or preserve beta-cell function and thus stabilize individuals with new onset type 1 diabetes. The Prevent Diabetes Group (PDG) has been organized on the premise that significant advances can be made by a cooperative approach to the design and conduct of human clinical intervention trials both to prevent development of type I diabetes mellitus and to preserve beta-cell function in recent onset type I diabetes mellitus. The goal is to create a dynamic and flexible environment where investigators can work together to develop and implement research protocols. Each member of the group supports the concept of inter-institutional studies by pooling clinical case material and laboratory resources with other collaborating members, and of participating in study committees for the purpose of developing new ideas and analyzing or evaluating the results of studies related to the prevention and/or stabilization of human type I diabetes mellitus. For the purposes of these studies, the disease is divided into several stages of development (early, advanced, and late prediabetes; new onset diabetes; etc.). The purpose of dividing subjects into these disease stages is that different intervention strategies might be tested in different groups. For example, one might be willing to accept a greater risk of side effects in late disease, e.g. new onset type I diabetes, than in any of the stages of prediabetes. Likewise, one might accept greater risk in late prediabetes than in early or advanced prediabetes. Moreover, different strategies may seem more applicable in one category than another. The PDG is made up of member institutions (clinical centers) and investigators organized into Committees, and facilitated by an Operations Office, a Statistical Office, and several Reference Laboratories. This provides the basic stricture for an ongoing series of trials. The Reference laboratories will assure standardized, reliable methods are used. Predictive models will be compared. In addition, we propose to conduct and monitor two pilot and feasibility studies to test the potential of intervention with [1] periodic courses of intravenous insulin, with or without accompanying chronic subcutaneous insulin, and [2] gut antigen presentation by oral administration of potential autoantigens to induce immunological tolerance.

I型或胰岛素依赖型糖尿病（IDDM）是由遗传因素引起的。 易感个体由于免疫介导的破坏， 胰岛分泌胰岛素的β细胞。出现临床 糖尿病的症状代表了慢性进展性糖尿病的终点， β细胞功能下降，当大多数β细胞 已经消失了由于1型糖尿病是从一种 持续的，免疫介导的破坏性过程，它可以预测与 一定程度的准确性，那么有可能在一个点上的干预 在这个漫长的前驱期将阻止这种现象的发生或延续 β细胞的破坏。一些潜在的干预策略 存在可能会减缓或阻止I型糖尿病的发展 糖尿病，和/或保持β细胞功能，从而稳定 1型糖尿病患者的饮食习惯预防糖尿病小组 (PDG)组织的前提是， 通过合作的方法来设计和进行人类临床 预防I型糖尿病的干预试验 在近期发作的I型糖尿病患者中， 糖尿病的我们的目标是创造一个充满活力和灵活的 研究人员可以共同努力开发和实施 研究协议。该小组的每个成员都支持以下概念： 通过汇集临床病例材料进行机构间研究， 与其他合作成员的实验室资源，以及 参加研究委员会，以发展新思想 并分析或评估有关研究的结果， 预防和/或稳定人I型糖尿病。为 这些研究的目的，疾病分为几个阶段， 发展（早期、晚期和晚期前驱糖尿病;新发糖尿病; 等）。将受试者分为这些疾病阶段的目的是， 可以在不同的群体中测试不同的干预策略。为 例如，人们可能愿意接受更大的副作用风险， 晚期疾病，如新发I型糖尿病，比任何阶段的 糖尿病前期同样，人们可能会接受晚期前驱糖尿病的风险更大 而不是早期或晚期前驱糖尿病。此外，不同的战略可能 似乎更适用于一个类别比另一个。PDG由以下部分组成 成员机构（临床中心）和研究者组成 委员会，并由一个业务办公室、一个统计办公室、 和几个参考实验室。这为以下方面提供了基本的限制： 一系列正在进行的审判参考实验室将确保 使用标准化、可靠的方法。预测模型将 比较了此外，我们建议进行两项试验计划， 可行性研究，以测试干预的潜力[1] 静脉注射胰岛素的周期性疗程，伴或不伴 慢性皮下胰岛素，和[2]口服肠道抗原呈递 施用潜在的自身抗原以诱导免疫 宽容