NIDDM PRIMARY PREVENTION TRIAL (DPT-2)

这项研究提案的目标是作为临床医生参与 中心在一项多中心试验中确定是否发展为非 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NIDDM的高危人群 句号。糖耐量受损(IGT)的I组受试者将 通过口服葡萄糖从非裔美国少数民族中辨认出来 将确定耐量试验(OGTT)和患有IGT的Il组受试者 从患有妊娠期糖尿病的女性的大型数据库中提取。 在对这些人群进行筛查的过程中，预计 未诊断的糖尿病患者的比例将通过以下方式确定 天哪。那些没有空腹高血糖(&lt；140 mg/dl)的人代表着非常 进展为空腹高血糖的高危人群 纳入试验(第III组)。 招募的受试者将被随机分配到通常的转介护理中 (RC)小组和一个旨在实现以下目标的特别干预小组 调整饮食(减重4%)和增加体力活动(600 大卡/周)，为期4-5年。SI组的一半人还将 接受降血糖药物二甲双胍(850毫克，每天两次)和 另一半是安慰剂。年度OGTT的表现将被用来比较 三组中每一组的空腹高血糖的恶化速度 治疗组，除胰岛素和心血管改变外 风险因素。患有IGT的受试者将与那些 最初被发现患有糖尿病，自自然病史和反应 两者的治疗方法可能有所不同。 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预防 它们的恶化为NIDDM提供了一种新的治疗方法 这种病。

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.