DIABETES PREVENTION TRIAL--TYPE I DIABETES

这是一项由美国国立卫生研究院支持的全国性研究，旨在确定在胰岛细胞抗体阳性但未发生葡萄糖耐受不良的个体中是否可以预防I型糖尿病。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（5年内发生IDDM的概率为50%）的患者将被提供一项随机试验，不治疗与每日皮下注射长效胰岛素以试图预防糖尿病的发展。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。（当地筛选500例）第二步：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。（2名受试者）第三步：干预：对高危类患者实施胰岛素干预方案。1名受试者停止注射，但将进行葡萄糖耐量试验。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。筛查和分期由克利夫兰诊所基金会的道格拉斯·罗杰斯医生完成。迄今为止，已筛选了约500人，但只有1名受试者符合肠外胰岛素治疗研究的资格（在本次GCRC进行）。

This is a national study supported by NIH to determine if Type I diabetes can be prevented in individuals who are positive for Islet cell antibodies but have not developed glucose intolerance. 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 (>50% of developing IDDM within 5 years) will be offered a randomized trial of no treatment versus daily subcutaneous injections of long-acting insulin to attempt to prevent the development of diabetes. 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. (500 screened locally) STEP II: STAGING: Definition of risk categorized by staging of ICA positive patients as to the risk of developing clinical IDDM. (2 subjects) STEP III: INTERVENTION: Implementation of the insulin intervention protocol for patients in the high risk category. (1 subject - discontinued injections but will have a glucose tolerance test. Patients that are in step 2 or step 3 will be studied in the General Clinical Research Center at University Hospitals. Screening and staging are done by Dr. Douglas Rogers at the Cleveland Clinic Foundation. To date approximately 500 individuals have been screened but only 1 subject has qualified for the parenteral insulin treatment study (done at this GCRC).