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: 7110217
• 负责人: ROBERT E RATNER
• 金额: $ 207.41万
• 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 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7110217
• 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）：虽然美洲印第安人曾经免受心血管疾病 (CVD) 的影响，但现在其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身上。 因此，必须制定减少糖尿病患者心血管疾病的干预策略并在该人群中进行验证。 该提案是一项为期 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）对 CVD 的影响，与小于或等于 100 mg/dL 和小于或等于 130/85 mmHg 的通常目标相比。 选择这些切点是因为该人群的平均 LDL 和血压水平较低，但 LDL、血压和 CVD 之间在低于当前目标水平时存在密切关系。 主要终点是颈动脉内膜中层厚度。 次要终点包括超声心动图、脂蛋白、蛋白尿和 C 反应蛋白 (CRP) 的心脏功能测量。 该研究将招募 488 名年龄超过 40 岁的患有糖尿病的美国印第安人男性和女性，并将在涉及亚利桑那州菲尼克斯/萨克顿的印第安健康/部落初级保健机构的四个现场中心进行；亚利桑那州钦利；南达科他州拉皮德城/派恩里奇；和俄克拉荷马州劳顿，听取了美洲印第安人医生和社区成员的意见。 研究结果将为制定以社区为基础的计划来治疗和预防美洲印第安人中心血管疾病的流行提供所需的证据。 这些数据对于了解强化危险因素减少对美国所有人群的糖尿病患者动脉粥样硬化负担和心脏功能的影响也很有价值，并为确定糖尿病患者的低密度脂蛋白和血压治疗目标提供证据。