Stop Atherosclerosis in Native Diabetics study (SANDS)

在本土糖尿病研究中阻止动脉粥样硬化 (SANDS)

• 批准号: 6801125
• 负责人: Barbara v Howard
• 金额: $ 210.67万
• 依托单位: MEDSTAR HEALTH RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6801125
• 关键词: Native Americans; acute phase protein; albuminuria; atherosclerosis; blood pressure; cardiovascular disorder therapy; cardiovascular function; carotid artery; cholesterol; clinical research; clinical trials; cooperative study; diabetes mellitus; disease /disorder prevention /control; echocardiography; human subject; human therapy evaluation; longitudinal human study; low density lipoprotein; medical complication; medically underserved population; patient oriented research; ultrasound blood flow measurement

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.

描述（由申请人提供）：尽管一旦受到了心血管疾病（CVD）的保护，但美国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，必须在该人群中开发和验证糖尿病个体中减少CVD的干预策略。 该提议是针对一项为期3年的随机试验，以检查对密集LDL降低（目标小于或等于75 mg/dL）的CVD的影响，并且与通常小于或等于100 mg/dl或等于100 mg/dl或等于130/85毫米的平均目标相比，与通常的目标相比，与通常的靶标相比，与通常的靶标相比，相比之下，该靶标小于或等于115/75 mmHg）。 之所以选择这些切口，是因为该人群中的平均LDL和血压水平较低，但是LDL，血压和CVD之间的关系很强，低于当前目标的水平。 主要终点将是颈动脉内膜厚度。 次要终点将包括超声心动图，脂蛋白，蛋白尿和C反应蛋白（CRP）的心脏功能度量。 这项研究将招募488名40岁以上的糖尿病美洲印第安人男女，并将在涉及亚利桑那州凤凰城/萨卡顿的印度卫生/部落初级保健设施的四个野外中心进行；亚利桑那州钦尔；南达科他州拉皮德城/松岭；和俄克拉荷马州的劳顿（Lawton），并提出了美国印第安人医生和社区成员的意见。 研究结果将为制定基于社区的计划提供所需的证据，以治疗和预防美国印第安人中CVD的流行。 该数据也将在了解美国所有人群中糖尿病患者中的强化风险因素减少对动脉粥样硬化负担和心脏功能的影响方面具有价值，并为确定LDL和糖尿病患者的血压治疗目标提供了证据。