Stop Atherosclerosis in Native Diabetics study (SANDS)

描述（由申请人提供）：虽然曾经免受心血管疾病（CVD）的侵害，但美洲印第安人现在的发病率高于美国总人口。大多数心血管疾病病例发生在糖尿病患者身上。因此，在这一人群中开发和验证减少糖尿病患者心血管疾病的干预策略是势在必行的。该建议是一项为期3年的随机试验，以检查强化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）对CVD的影响，而通常的目标是小于或等于100 mg/dL和小于或等于130/85 mmHg。之所以选择这些临界值，是因为该人群的平均LDL和血压水平较低，但在低于当前目标水平时，LDL、血压和心血管疾病之间存在很强的相关性。主要终点是颈动脉内内侧厚度。次要终点包括超声心动图心功能测量、脂蛋白、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人男性和女性，并将在四个实地中心进行，涉及亚利桑那州凤凰城/萨卡顿的印第安人健康/部落初级保健设施；亚利桑那州Chinle;拉皮德城/松岭，南达科他州；以及俄克拉何马州的劳顿，并听取了美国印第安医生和社区成员的意见。研究结果将为开发以社区为基础的项目提供必要的证据，以治疗和预防心血管疾病在美洲印第安人中流行。这些数据对于理解在所有美国人群中强化危险因素降低对糖尿病患者动脉粥样硬化负担和心功能的影响也很有价值，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.