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: 8302250
• 负责人: Anastassios G Pittas
• 金额: $ 39.45万
• 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/8302250
• 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.

描述（由申请人提供）：基于我们小组的NIH最近支持的人类研究，以及其他人的工作，维生素D已成为2型糖尿病（T2DM）风险的潜在修饰剂。在纵向观察研究中，较高的维生素D状态与T2DM风险降低高达83％有关。但是，目前尚不存在支持一般补充的证据，因为维生素D状态与T2DM之间的有利关联可能会被多种因素混淆，并且没有专门设计用于测试维生素D对降低T2DM风险的影响的公开试验；因此，无法得出确定的结论，即维生素D在预防T2DM方面的作用。该应用程序的目的扩展了我们以前的工作并补充了我们在该领域正在进行的工作，它是要采取必要的下一步来解决因果关系问题，并量化维生素D在T2DM风险中的保护益处（如果存在）。我们提出了一项多中心，随机，双掩盖的安慰剂对照试验，将在美国的几个经验丰富的临床部位中进行，以评估维生素D是否是预防高风险个体（维生素D和2型糖尿病型糖尿病，D2D试验）中T2DM的有效干预措施。拟议的D2D试验将根据U01机制进行，将是针对T2DM风险的成年人的主要预防试验，以测试是否提高血浆25OHD浓度延迟延迟的糖尿病到糖尿病时间的进展”。该试验的需求已在最近的文献中认识到了Grant应用程序中的最终申请。目前的应用程序是授予u3的最终计划。 U34是及时提交的申请（U01），以支持拟议的临床试验对维生素D和T2DM预防的临床重要领域具有很高的影响。补充维生素D将纳入常规医学方法，以防止T2DM并改善个人和社会疾病负担。最后，由高素质的研究人员组成的团队增强了研究的影响，具有互补的专业知识和经验，用于运行基于营养的多中心试验，其中许多人以前曾共同努力，这最大程度地提高了试验行为成功的可能性。

项目成果

Financial management of large, multi-center trials in a challenging funding milieu.

• DOI: 10.1186/s13063-018-2638-z
• 发表时间: 2018-05-03
• 期刊: Trials
• 影响因子: 2.5
• 作者: Lovegreen O;Riggs D;Staten MA;Sheehan P;Pittas AG
• 通讯作者: Pittas AG

Vitamin D supplementation for prevention of cancer: The D2d cancer outcomes (D2dCA) study.

补充维生素 D 预防癌症：D2d 癌症结果 (D2dCA) 研究。

• DOI: 10.1016/j.cct.2019.04.015
• 发表时间: 2019
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: Chatterjee,Ranee;Erban,JohnK;Fuss,Paul;Dolor,Rowena;LeBlanc,Erin;Staten,Myrlene;Sheehan,Patricia;Pittas,Anastassios;D2dResearchGroup
• 通讯作者: D2dResearchGroup