Stop Atherosclerosis in Native Diabetics study (SANDS)

描述（由申请人提供）：虽然曾经受到心血管疾病（CVD）的保护，但美洲印第安人现在的发病率高于美国普通人群。 大多数CVD病例发生在糖尿病患者中。 因此，必须制定干预策略，以减少糖尿病患者的心血管疾病，并在这一人群中进行验证。 本提案是一项为期3年的随机试验，旨在检查强化LDL降低（目标小于或等于75 mg/dL）和强化血压降低（目标小于或等于115/75 mmHg）与常规目标小于或等于100 mg/dL和小于或等于130/85 mmHg相比对CVD的影响。 选择这些临界点是因为该人群的平均LDL和血压水平较低，但在低于当前目标的水平下，LDL，血压和CVD之间存在强烈的相关性。 主要终点为颈动脉内膜-中膜厚度。 次要终点将包括通过超声心动图测量的心功能、脂蛋白、白蛋白尿和C反应蛋白（CRP）。 该研究将招募488名40岁以上的糖尿病美国印第安男性和女性，并将在涉及亚利桑那州凤凰城/萨卡顿的印第安健康/部落初级保健机构的四个现场中心进行;亚利桑那州钦勒;南达科他州拉皮德城/松树岭;和俄克拉荷马州劳顿，由美国印第安医生和社区成员提供意见。 研究结果将为制定以社区为基础的计划提供必要的证据，以治疗和预防美国印第安人中心血管疾病的流行。 这些数据也将有助于了解所有美国人群中糖尿病患者的动脉粥样硬化负荷和心脏功能的强化风险因素减少的影响，并为确定糖尿病患者的LDL和血压治疗目标提供证据。

DESCRIPTION (provided by applicant): Although once protected from cardiovascular disease (CVD), American Indians now have incidence rates higher than the general US population. The majority of CVD cases occur in individuals with diabetes. It is therefore imperative that intervention strategies to reduce CVD in diabetic individuals be developed and validated in this population. This proposal is for a randomized 3-year trial to examine the effects on CVD of intensive LDL reduction (goal less than or equal to 75 mg/dL) and intensive blood pressure lowering (goal less than or equal to 115/75 mmHg), compared to usual targets of less than or equal to 100 mg/dL and less than or equal to 130/85 mmHg. These cutpoints were chosen because mean LDL and blood pressure levels are lower in this population, but there is a strong relation between LDL, blood pressure, and CVD at levels below current targets. The primary endpoint will be carotid intimal-medial thickness. Secondary endpoints will include cardiac function measures by echocardiography, lipoproteins, albuminuria, and C-reactive protein (CRP). The study will enroll 488 diabetic American Indian men and women more than 40 years of age and will be conducted in four field centers involving Indian Health/Tribal primary care facilities in Phoenix/Sacaton, Arizona; Chinle, Arizona; Rapid City/Pine Ridge, South Dakota; and Lawton, Oklahoma, with input from American Indian physicians and community members. Study results will provide evidence needed to develop community-based programs to treat and prevent the epidemic of CVD among American Indians. The data will also be valuable in understanding the effects of intensive risk-factor reduction on atherosclerosis burden and cardiac function in diabetic individuals in all US populations and provide evidence for determining LDL and blood pressure treatment goals for diabetic patients.