DIABETES PREVENTION TRIAL--TYPE I DIABETES

这是一个多中心的方案，筛选高风险的患者成为1型糖尿病，并干预治疗，试图防止糖尿病的发展。最近，使用胰岛细胞自身抗体（ICA）来识别在未来5年内有50%机会发展为IDDM的个体成为可能。IDDM患者的主要亲属患ICA的风险增加了10倍，这是本试验的目标人群。被划分为发展IDDM的中度风险或高风险的患者将被提供两种随机干预方案中的一种。那些高风险类别的患者（在未来5年内发展为IDDM的50%以上）将被提供一项不治疗与每日皮下注射长效胰岛素的随机试验。本研究有三个独立的阶段，每个阶段都有不同的目标：步骤1：筛查：通过确定ICA对亲属进行IDDM风险的初步合格筛查。步骤二：分期：根据ICA阳性患者发展为临床IDDM的风险分期，对风险进行定义。第三步：干预：对高危患者实施胰岛素干预方案。进入第2步或第3步的患者将在大学附属医院综合临床研究中心进行研究。

This is a multi-centered protocol to screen for patients at high risk of becoming type I diabetics, and to intervene with treatment to attempt to prevent the development of diabetes. It has recently become possible using islet cell autoantibodies (ICA) to identify individuals who have a 50 percent chance of developing IDDM within the next 5 years. Primary relatives of patients with IDDM have a tenfold increased risk of having ICA and this is the group that will be targeted in this trial. Patients who are classified as intermediate risk or high risk for developing IDDM will be offered one of two randomized intervention protocols. Those patients in the high risk category (greater than 50 percent of developing IDDM over the next 5 years) will be offered a randomized trial of no treatment versus daily subcutaneous injections of long-acting insulin. There are three separate stages of this study, each of which have separate objectives: STEP 1: SCREENING: Initial eligibility screening of relatives for IDDM risk by determining ICA. STEP II: STAGING: Definition of risk categorized by staging of ICA positive patients as to the risk of developing clinical IDDM. STEP III: INTERVENTION: Implementation of the insulin intervention protocol for patients in the high risk category. Patients that are in step 2 or step 3 will be studied in the General Clinical Research Center at University Hospitals.