Vitamin D and type 2 diabetes (D2d)

维生素 D 和 2 型糖尿病 (D2d)

• 批准号: 8660059
• 负责人: Anastassios G Pittas
• 金额: $ 1061.06万
• 依托单位: TUFTS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8660059
• 关键词: 25-hydroxyvitamin D; Address; Age; Albumins; American; Ancillary Study; Applications Grants; Area; Ascorbic Acid; Beta Carotene; Beta Cell; Blood Pressure; Body Weight decreased; C-reactive protein; Cardiovascular system; Cell secretion; Characteristics; Cholecalciferol; Clinical; Clinical Trials Design; DNA; Diabetes Mellitus; Diabetes prevention; Diet; Endocrine; Ethnic Origin; Etiology; Event; Excretory function; Folic Acid; Functional disorder; Funding; Geographic Locations; Glucose; Glycosylated hemoglobin A; Goals; Grant; Health; Hormone replacement therapy; Hour; Hyperglycemia; Individual; Institute of Medicine (U.S.); Insulin Resistance; Intake; Intervention; Knowledge; Laboratories; Life Style; Link; Lipids; Masks; Measures; Mission; Multicenter Trials; National Institute of Diabetes and Digestive and Kidney Diseases; Natural History; Non-Insulin-Dependent Diabetes Mellitus; Nutrient; OGTT; Observational Study; Oral; Outcome; Participant; Persons; Pharmaceutical Preparations; Pharmacotherapy; Placebo Control; Placebos; Plasma; Population; Prediabetes syndrome; Prevention; Primary Prevention; Public Health; Publishing; Qualifying; Race; Randomized; Reporting; Research; Research Design; Research Personnel; Research Priority; Residual state; Risk; Risk Factors; Role; Safety; Selenium; Strategic Planning; Subgroup; Supplementation; Symptoms; Testing; Time; United States National Institutes of Health; Urine; Vertebral column; Vitamin D; Whole Blood; Work; arm; base; burden of illness; cardiovascular risk factor; clinical practice; cost; design; diabetes risk; dietary supplements; editorial; effective intervention; experience; fasting plasma glucose; follow-up; high risk; improved; indexing; insulin secretion; insulin sensitivity; interest; meetings; modifiable risk; novel diagnostics; nutrition; prevent; prevention clinical trial; protective effect; public health relevance; response; safety testing; waist circumference; weight maintenance

DESCRIPTION (provided by applicant): The diabetes population and related costs are expected to double in the next quarter century, as more than 79 million Americans are at risk of developing diabetes. In trials, lifestyle changes aimed at weight loss were successful at reducing risk of type 2 diabetes (t2DM), the most common type of diabetes. However, long-term weight maintenance in the clinical setting has proved elusive. Importantly, even after successful weight loss, substantial residual risk (~40-50%) remains and may be attributable to other modifiable factors. Several medications used to treat established t2DM have also been studied for t2DM prevention and many have been shown to delay incident diabetes; however, the role of pharmacotherapy for diabetes prevention is not clear. Therefore, there is a continued and pressing need for identification of modifiable risk factors and interventions that are safe, inexpensive and acceptable to prevent t2DM and decrease diabetes-related disease burden. Based on a large body of recently published studies, vitamin D has emerged as a potential determinant of type 2 diabetes (t2DM) risk. In longitudinal observational studies, higher vitamin D status was associated with up to 83% reduction in the risk of t2DM. However, the evidence to support vitamin D supplementation for prevention of t2DM remains inconclusive. The favorable association between vitamin D status and t2DM risk in observational studies may be confounded by a variety of factors. Directly extending our prior work, the goal of the research described in this grant application is to address the issue of causality by evaluating whether vitamin D is an effective intervention for prevention of t2DM among high-risk individuals. We propose to conduct the vitamin D and type 2 diabetes (D2d) study, a multicenter, randomized, double-masked, placebo- controlled, parallel-group primary prevention clinical trial to evaluate the safety of vitamin D supplementation and its effect on the time to onset of diabetes in participants with pre-diabetes. The need for a trial such as the D2d study has been recognized in recent editorials and reviews, including the 2011 Institute of Medicine report on dietary reference intakes for vitamin D, which identified diabetes as one of the most promising non-skeletal outcomes with an urgent need for rigorously conducted trials to confirm the promising results seen in observational and mechanistic studies. The proposed trial, therefore, addresses an important and timely question and has the potential for significant impact in the clinically important area of t2DM prevention with direct public health implications. The potential impact of the study is heightened by the assembly of a team of highly qualified investigators with complementary expertise and experience in conducting nutrition-based multicenter trials, many of whom have worked together previously.

描述（由申请人提供）：由于超过7,900万美国人有患糖尿病的风险，糖尿病人口和相关费用预计将翻一番。在试验中，针对体重减轻的生活方式改变成功地降低了2型糖尿病（T2DM）的风险，这是最常见的糖尿病类型。但是，临床环境中的长期体重维持已经证明难以捉摸。重要的是，即使成功减肥后，仍然存在实质性残留风险（约40-50％），并且可能归因于其他可修改因素。还研究了用于治疗已建立的T2DM的几种药物预防T2DM，许多药物已被证明延迟了入射糖尿病。但是，药物治疗在预防糖尿病方面的作用尚不清楚。因此，持续且迫切需要确定可修改的危险因素和干预措施，这些因素和干预措施是安全，廉价且可以接受的，以防止T2DM并减轻与糖尿病相关的疾病负担。基于最近发表的大量研究，维生素D已成为2型糖尿病（T2DM）风险的潜在决定因素。在纵向观察研究中，较高的维生素D状态与T2DM风险降低了多达83％。但是，支持补充T2DM的维生素D的证据尚无定论。在观察性研究中，维生素D状态与T2DM风险之间的有利关联可能会被多种因素混淆。直接扩展了我们先前的工作，本赠款申请中描述的研究的目标是通过评估维生素D是否是预防高风险个体T2DM的有效干预来解决因果关系问题。我们建议进行维生素D和2型糖尿病（D2D）研究，这是一项多中心，随机，双掩盖，安慰剂控制的，平行组的，平行组的一级预防临床试验，以评估补充维生素D的安全性及其对糖尿病患者糖尿病时间的影响。在最近的社论和评论中已经认识到，对D2D研究等试验的需求，包括2011年医学研究所的饮食参考摄入量报告维生素D的摄入量，该报告确定糖尿病是最有前途的非骨骼结果之一，迫切需要进行严格进行的试验，以确认在观察和机械研究中看到有希望的结果。因此，拟议的试验解决了一个重要且及时的问题，并有可能对T2DM预防的临床重要领域产生重大影响，并具有直接的公共卫生影响。一支高素质的研究人员组装具有互补的专业知识和经验在进行营养的多中心试验方面，这项研究的潜在影响会增强，其中许多人以前曾共同努力。