Vitamin D and Type 2 Diabetes (D2d)

维生素 D 和 2 型糖尿病 (D2d)

• 批准号: 9974505
• 负责人: Anastassios G Pittas
• 金额: --
• 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 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9974505
• 关键词: 25-hydroxyvitamin D; Address; Adherence; Adult; Albumins; American; Area; Beta Cell; Blood; Blood Pressure; C-reactive protein; Cardiovascular system; Cell physiology; Cell secretion; Characteristics; Cholecalciferol; Clinical; Clinical Trials Data Monitoring Committees; Conflict (Psychology); Data; Development; Diabetes Mellitus; Diagnostic; Diet; Dose; Double-Blind Method; Endocrine; Enrollment; Etiology; Evaluation; Event; Excretory function; Funding; Glucose; Glycosylated hemoglobin A; Goals; Grant; Heterogeneity; Hour; Institute of Medicine (U.S.); Institutional Review Boards; Insulin Resistance; Intake; Knowledge; Lipids; Longitudinal observational study; Masks; Measures; Natural History; Non-Insulin-Dependent Diabetes Mellitus; OGTT; Observational Study; Oral; Outcome; Participant; Persons; Placebos; Plasma; Population; Prediabetes syndrome; Prevention; Preventive; Primary Prevention; Process; Protocols documentation; Public Health; Race; Randomized; Reporting; Research; Research Priority; Residual state; Risk; Risk Factors; Role; Safety; Societies; Subgroup; Supplementation; Testing; Toxic effect; United States National Institutes of Health; Urine; Vitamin D; Vitamin D supplementation; Vitamin D2; base; burden of illness; design; diabetes risk; editorial; fasting plasma glucose; follow-up; high risk; improved; indexing; pill; placebo group; prevention clinical trial; recruit; secondary outcome; treatment effect

Project Summary / Abstract Based on a large body of evidence, 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, and long-term, well-designed and adequately powered trials are lacking. The “Vitamin D and type 2 diabetes” (D2d) study is being funded by NIH to provide definitive conclusions regarding the role of vitamin D supplementation for prevention of t2DM. D2d is an ongoing, multicenter, randomized (1:1), double-masked, placebo-controlled, parallel-group, primary prevention clinical trial with two groups (oral 4,000 IU/day of vitamin D3 vs. placebo) among participants at risk for diabetes who are followed for incident diabetes. D2d is designed as an event-driven trial. The study met its enrollment goal in December 2016 and 98% of enrolled participants continue in D2d after a mean follow-up of 19 months. Adherence to study pills is very high (>92% of pills prescribed). The primary aim of the renewal grant is to continue follow- up of the D2d population (N=2,423) and complete the study according to the protocol, which has been approved by the DSMB and all participating IRBs, to answer the study’s primary question: does oral daily vitamin D3 supplementation lower risk of incident diabetes among U.S. adults at high risk for diabetes? Secondary Aims will assess: the heterogeneity of treatment effect of vitamin D supplementation on incident diabetes in subgroups defined by key baseline characteristics (e.g., blood 25-hydroxyvitamin D concentration), effects on secondary outcomes (e.g., blood pressure), and the long-term safety and tolerability of 4000 IU/day of vitamin D3 supplementation. Finally, data from the D2d placebo group will define the natural history of pre- diabetes using the new American Diabetes Association diagnostic criteria that include hemoglobin A1c. The need for a trial such as the D2d study has been recognized in multiple 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.

项目摘要 /摘要 基于大量证据，维生素D已成为2型糖尿病的潜在决定 （T2DM）风险。在纵向观察研究中，较高的维生素D状态与多达83％有关 降低T2DM的风险。但是，支持补充维生素D的证据以预防 T2DM仍然没有定论。维生素D状态与T2DM风险之间的有利关联 研究可能会被各种因素以及长期，精心设计和充分动力的试验所困惑 缺乏。 NIH资助了“维生素D和2型糖尿病”（D2D）研究，以提供明确的结论 关于补充维生素D在预防T2DM的作用。 D2D是一个持续的，多中心， 随机（1：1），双掩盖，安慰剂对照，平行组，主要预防临床试验，两项试验 组（口服4,000 IU/天维生素D3与安慰剂）的参与者有糖尿病风险 用于事件糖尿病。 D2D被设计为事件驱动的试验。该研究达到了12月的入学目标 在平均随访19个月后，2016年和98％的入学参与者继续在D2D中继续进行。坚持 学习丸非常高（> 92％的处方药）。续集赠款的主要目的是继续跟进 - 在D2D人群中（n = 2,423），并根据该方案完成研究， 由DSMB和所有参与的IRB批准，以回答研究的主要问题：每天做口头 维生素D3补充较低的糖尿病风险的美国成年人中糖尿病的风险较低？ 次要目标将评估：补充维生素D对事件的治疗效应的异质性 由关键基线特征定义的亚组中的糖尿病（例如血液25-羟基维生素D浓度）， 对次级结果的影响（例如血压），以及4000 IU/天的长期安全性和耐受性 补充维生素D3。最后，来自D2D安慰剂组的数据将定义前的自然历史 使用包括血红蛋白A1C在内的新美国糖尿病协会诊断标准的糖尿病。 对D2D研究等试验的需求已在多个社论和评论中得到认可，包括 2011年医学研究所关于维生素D的饮食参考摄入量报告，该报告将糖尿病确定为一种 迫切需要严格进行试验的最有希望的非骨骼结果，以确认 在观察和机械研究中看到的有希望的结果。