Vitamin D for Type 2 Diabetes (D2D trial)

维生素 D 治疗 2 型糖尿病（D2D 试验）

• 批准号: 8120179
• 负责人: Anastassios G Pittas
• 金额: $ 39.75万
• 依托单位: TUFTS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-20 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8120179
• 关键词: Address; Adult; Age; American; Applications Grants; Area; Body mass index; Cholecalciferol; Chronic Phase; Clinical; Clinical Trials; Communities; Complement; Data; Diabetes Mellitus; Diagnosis; Disease; Effectiveness; Etiology; Future; Glucose; Glycosylated hemoglobin A; Goals; Grant; Health; Hormone replacement therapy; Hour; Human; Hyperglycemia; Individual; Intervention; Intervention Studies; Laboratories; Link; Literature; Masks; Measures; Medical; Multicenter Trials; National Institute of Diabetes and Digestive and Kidney Diseases; Natural History; Non-Insulin-Dependent Diabetes Mellitus; OGTT; Observational Study; Phase; Physicians; Plasma; Prediabetes syndrome; Prevention; Primary Prevention; Public Health; Publishing; Qualifying; Race; Randomized; Research; Research Design; Research Personnel; Risk; Risk Factors; Role; Running; Supplementation; Symptoms; Testing; Time; United States National Institutes of Health; Vertebral column; Vitamin D; Vitamin D Deficiency; Vitamin E; Work; base; blood glucose regulation; burden of illness; clinical research site; cost; design; diabetes risk; effective intervention; experience; fasting plasma glucose; follow-up; fortification; high risk; improved; insulin secretion; insulin sensitivity; meetings; novel diagnostics; nutrition; placebo controlled study; population based; prevent; randomized trial; success; working group

DESCRIPTION (provided by applicant): Based on recent NIH-supported human studies from our group and work from others, vitamin D has emerged as a potential modifier of type 2 diabetes (t2DM) risk. In longitudinal observational studies, higher vitamin D status is associated with up to 83% reduction in the risk of t2DM. However, the evidence to support general supplementation does not currently exist because the favorable association between vitamin D status and t2DM may be confounded by a variety of factors and there are no published trials specifically designed to test the effects of vitamin D on reducing t2DM risk; therefore, definitive conclusions cannot be drawn on the role of vitamin D for prevention of t2DM. The goal of this application, which extends our previous work and complements our ongoing work in this area, is to take the necessary next step to address the issue of causality and to quantify the protective benefit of vitamin D in t2DM risk, if present. We propose a multi-center, randomized, double-masked, placebo-controlled trial to be conducted among several experienced clinical sites across the U.S. to evaluate whether vitamin D is an effective intervention for prevention of t2DM among high- risk individuals (vitamin D and type 2 Diabetes, D2D trial). The proposed D2D trial, which will be conducted under the U01 mechanism, will be a primary prevention trial of adults at risk for t2DM, to test whether raising plasma 25OHD concentration delays 'time-to-diabetes- progression". The need for such a trial has been recognized in the recent literature, as we describe in the grant application. The present application is for a U34 Implementation Planning grant to plan the proposed study. We expect the final product of the U34 grant to be the timely submission of an application (U01) to support the conduct of the proposed clinical trial. The proposed D2D trial has a high potential impact in the clinically important areas of vitamin D and t2DM prevention with extensive public health implications. We expect study results to define the role of improving vitamin D status in modifying t2DM risk. If the trial confirms a favorable benefit/harm ratio of raising 25OHD, then vitamin D supplementation will be integrated into conventional medical approaches to prevent t2DM and ameliorate personal and societal disease burden. Finally, the impact of the study is heightened by the assembled team of highly qualified investigators with complementary expertise and experience in running nutrition-based multicenter trials, many of whom have worked together previously, which maximizes the likelihood of trial conduct success. PUBLIC HEALTH RELEVANCE: The research addresses important health issues of relevance to NIDDK and ODS. Vitamin D deficiency and type 2 diabetes are highly prevalent in the U.S., and therefore the proposed study is of potential high impact given its broad applicability, especially given that the cost of supplementation or fortification with vitamin D is relatively inexpensive compared to treating the chronic phase of type 2 diabetes and its complications. We expect study results of the proposed trial, which will test whether a causal link between vitamin D and type 2 diabetes exists, to define the role of optimizing vitamin D status in modifying risk of type 2 diabetes. If the trial confirms a favorable benefit/harm ratio of vitamin D on type 2 diabetes risk, then vitamin D supplementation will be integrated into conventional medical approaches to prevent type 2 diabetes in the more than 50 million Americans who are at risk of developing type 2 diabetes.

描述（由申请人提供）：根据我们小组最近 NIH 支持的人体研究以及其他人的工作，维生素 D 已成为 2 型糖尿病 (t2DM) 风险的潜在调节剂。在纵向观察研究中，较高的维生素 D 水平与 2 型糖尿病风险降低高达 83% 相关。然而，目前尚不存在支持一般补充的证据，因为维生素 D 状态与 2 型糖尿病之间的有利关联可能会受到多种因素的干扰，并且没有已发表的试验专门用于测试维生素 D 对降低 2 型糖尿病风险的影响；因此，对于维生素 D 在预防 2 型糖尿病中的作用尚不能得出明确的结论。该应用程序扩展了我们之前的工作并补充了我们在该领域正在进行的工作，其目的是采取必要的下一步来解决因果关系问题，并量化维生素 D 对 t2DM 风险（如果存在）的保护作用。我们建议在美国多个经验丰富的临床中心进行一项多中心、随机、双盲、安慰剂对照试验，以评估维生素 D 是否是预防高危人群 2 型糖尿病的有效干预措施（维生素 D 和 2 型糖尿病，D2D 试验）。拟议的 D2D 试验将在 U01 机制下进行，将是对有 t2DM 风险的成年人的一级预防试验，以测试提高血浆 25OHD 浓度是否会延迟“糖尿病进展时间”。正如我们在拨款申请中所述，最近的文献已认识到进行此类试验的必要性。目前的申请是一项 U34 实施计划拨款，以规划拟议的研究。我们预计该试验的最终产品 U34 资助及时提交申请（U01）以支持拟议的临床试验的进行。拟议的 D2D 试验对维生素 D 和 t2DM 预防的临床重要领域具有巨大的潜在影响，并具有广泛的公共卫生影响。我们期望研究结果能够明确改善维生素 D 状态在改变 2 型糖尿病风险中的作用。如果试验证实提高 25OHD 具有有利的效益/危害比，那么 维生素 D 补充剂将被纳入传统医疗方法中，以预防 2 型糖尿病并减轻个人和社会疾病负担。最后，由高素质研究人员组成的团队增强了该研究的影响力，他们在开展基于营养的多中心试验方面具有互补的专业知识和经验，其中许多人以前曾合作过，这最大限度地提高了试验成功的可能性。 公共卫生相关性：该研究解决了与 NIDDK 和 ODS 相关的重要健康问题。维生素 D 缺乏症和 2 型糖尿病在美国非常普遍，因此，鉴于其广泛的适用性，拟议的研究具有潜在的巨大影响，特别是考虑到与治疗 2 型糖尿病慢性期及其并发症相比，补充或强化维生素 D 的成本相对便宜。我们预计拟议试验的研究结果将测试维生素 D 与 2 型糖尿病之间是否存在因果关系，以确定优化维生素 D 状态在改变 2 型糖尿病风险中的作用。如果试验证实维生素 D 对 2 型糖尿病风险具有有利的益处/危害比，那么维生素 D 补充剂将被纳入传统医疗方法中，以预防超过 5000 万有患 2 型糖尿病风险的美国人患 2 型糖尿病。