NIDDM PRIMARY PREVENTION TRIAL (DPT-2)

本研究提案的目的是作为临床参与者 中心的多中心试验，以确定是否发展非 胰岛素依赖性糖尿病（NIDDM）是可以预防的。我们建议 在12个月内确定200名患有NIDDM的高风险受试者， 期 第I组糖耐量受损（IGT）受试者将 通过口服葡萄糖从非洲裔美国少数群体中确定 耐受性试验（OGTT）和II组IGT受试者将被鉴定 从一个有过妊娠后糖尿病的妇女的大数据库中。 在筛选这些人群的过程中，预计 将通过以下指标确定未诊断糖尿病的受试者比例 OGTT 那些没有空腹高血糖症（<140 mg/dl）的人代表了非常高的血糖水平。 进展为空腹高血糖症的高危人群， 试验组（III组）。 招募的受试者将随机分配至常规转诊治疗 (RC)一个特别干预小组（SI），旨在实现 饮食调整（4%的体重减轻）和增加体力活动（600 Kcal/周），持续4-5年。 此外，SI集团的一半成员将 接受降糖药二甲双胍（850 mg b.i.d.），和 另一半安慰剂。 每年OGTT的表现将用于比较 三组中每一组的空腹高血糖恶化率 治疗组，除了胰岛素和心血管 危险因素 IGT受试者将与那些 最初发现患有糖尿病，自自然史和反应 两者之间的治疗可能有所不同。 预计对糖尿病高危患者的干预， 饮食、体力活动或药物可能会减缓或阻止 他们恶化为NIDDM，并提供了一种新的治疗方法， 这种疾病。

The objectives of this research proposal is to participate as a clinical center in a multicenter trial to determine whether the development of non- insulin dependent diabetes (NIDDM) can be prevented. We propose to identify 200 subjects at high risk for developing NIDDM over a 12-month period. Group I subjects with impaired glucose tolerance (IGT) will be identified from the African-American minority group by oral glucose tolerance testing (OGTT) and Group Il subjects with IGT will be identified from a large data base of women who have had post-gestational diabetes. In the course of screening these populations, it is anticipated that a proportion of subjects with undiagnosed diabetes will be identified by OGTT. Those without fasting hyperglycemia (<140 mg/dl) represent a very high risk group for progression to fasting hyperglycemia and will be included in the trial (Group III). Recruited subjects will be randomized either into a usual referred care (RC) group and a special intervention (SI) group aimed at achieving dietary modification (4% weight loss) and increased physical activity (600 Kcal/week) for a 4-5 year period. Half of the SI group will in addition receive the antihyperglycemic drug, Metformin (850 mg b.i.d.), and the other half placebo. Performance of yearly OGTT's will be used to compare rates of deterioration to fasting hyperglycemia in each of the three treatment groups, in addition to changes in insulin and cardiovascular risk factors. Subjects with IGT will be analyzed separately from those originally found to have diabetes, since the natural history and response to treatment may differ between the two. It is anticipated that intervention in patients at high risk for diabetes, with diet, physical activity or pharmacologic agents may slow or prevent their deterioration to NIDDM and offer a new approach to the treatment of this disease.