DIABETES PREVENTION PROGRAM

糖尿病预防计划

• 批准号: 2905648
• 负责人: ROBERT E RATNER
• 金额: $ 162.44万
• 依托单位: MEDSTAR HEALTH RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-08-20 至 2001-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2905648
• 关键词: African American; blood lipoprotein; carbohydrate balance; clinical trials; cooperative study; coronary disorder; disease /disorder prevention /control; exercise; family genetics; gestational diabetes mellitus; glucose tolerance; human subject; insulin sensitivity /resistance; metformin; noninsulin dependent diabetes mellitus; nutrition related tag; obesity; pancreatic islet function; prediabetic state; reducing diet; weight loss

DESCRIPTION (Directly incorporated from the application) The Washington Hospital Center/Medlantic Research Institute and the Howard University Medical School will collaborate in an effort to identify and enroll African Americans at risk for the development of IGT and NIDDM into a primary prevention trial. We will concentrate on recruitment of African Americans because of the disproportionate effect diabetes has on this community and the fact that Washington DC, with 70 percent African Americans, is estimated to have 52,000 citizens with diabetes, with half undiagnosed. The unique aspects of NIDDM in the African American population together with their disproportionate prevalence demand inclusion of African Americans as a major component of any primary prevention trial for NIDDM. Impaired glucose tolerance is the optimal time when interventions aimed at reversing the insulin resistance may prevent the progression of carbohydrate intolerance to NIDDM. We propose an efficient recruitment strategy based on the documented availability of groups enriched in the proportion of individuals with abnormal glucose tolerance. These include clinic patients seen at the Washington Hospital Center (WHC) and Howard University Hospital (HUH) who are obese and have relatives with NIDDM, patients with premature cardiovascular disease, and patients with a history of gestational diabetes. We propose a two by two factorial design to investigate aggressive lifestyle modification (diet and exercise), and pharmacologic intervention with metformin. Culturally appropriate interventions and follow-up techniques based on community support and input are presented designed to enhance retention and compliance. Primary endpoint determinations will be progression form IGT to NIDDM. Improvement of carbohydrate tolerance in newly diagnosed NIDDM will also be examined. Secondary end points include metabolic parameters related to insulin resistance, insulin secretion, lipoprotein changes and cardiovascular endpoints such as hypertension. Our center is experienced in the conduct of clinical trials and is committed to working with the Steering Committed in the design and conduct of the Trial.

描述（直接从申请中合并）华盛顿 医院中心/Medlantic 研究所和霍华德大学 医学院将合作努力识别和招收非洲人 美国人面临 IGT 和 NIDDM 发展为原发性疾病的风险 预防试验。 我们将专注于招募非裔美国人 因为糖尿病对这个社区的影响不成比例， 事实上，华盛顿特区有 70% 的非洲裔美国人 据估计，有 52,000 名公民患有糖尿病，其中一半未确诊。 非裔美国人中 NIDDM 的独特之处 由于其不成比例的患病率，要求将非洲人纳入其中 美国人是任何 NIDDM 初级预防试验的主要组成部分。 糖耐量受损是干预的最佳时机 逆转胰岛素抵抗可能会阻止病情的进展 NIDDM 碳水化合物不耐受。 我们建议高效的招聘 策略基于有记录的、丰富的群体的可用性 糖耐量异常的个体比例。 这些包括 在华盛顿医院中心 (WHC) 和霍华德医院就诊的诊所患者 大学医院 (HUH) 肥胖且有 NIDDM 亲属的人， 患有早发性心血管疾病的患者以及有病史的患者 妊娠糖尿病。 我们提出了一个二乘二的析因设计 调查积极的生活方式改变（饮食和锻炼），以及 二甲双胍的药物干预。 文化上适当 基于社区支持和投入的干预措施和后续技术 旨在提高保留率和合规性。 基本的 终点确定将是从 IGT 到 NIDDM 的进展。 改进 还将检查新诊断的 NIDDM 的碳水化合物耐受性。 次要终点包括与胰岛素相关的代谢参数 抵抗力、胰岛素分泌、脂蛋白变化和心血管 终点例如高血压。 我们中心在这方面经验丰富 临床试验并致力于与指导委员会合作 审判的设计和进行。