Rationale and Design of the Vitamin D and Type 2 Diabetes (D2d) Study: A Diabetes Prevention Trial
Rationale and Design of the Vitamin D and Type 2 Diabetes (D2d) Study: A Diabetes Prevention Trial
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DOI：
10.2337/dc14-1005
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发表时间：
2014-12-01
期刊：
影响因子：
16.2
通讯作者：
Staten, Myrlene A.
中科院分区：
文献类型：
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作者：
Pittas, Anastassios G.;Dawson-Hughes, Bess;Staten, Myrlene A.
观察性研究表明，维生素D可以降低2型糖尿病的风险。然而，缺乏长期试验的数据。维生素D与2型糖尿病（D2 d）研究是一项随机临床试验，旨在研究2型糖尿病高危人群中维生素D补充与糖尿病发展之间是否存在因果关系。研究设计和方法2d的设计得到了美国国家糖尿病、消化和肾脏疾病研究所（NIDDK）的U34计划基金的支持。最终方案得到了D2 D研究小组、数据和安全监测委员会以及NIDDK的批准。关键的合格标准是年龄30岁，BMI 24（亚裔美国人为22.5）至42 kg/m2，糖尿病风险增加（定义为满足美国糖尿病协会建立的糖尿病前期的三个血糖标准中的两个[空腹血糖100-125 mg/dL（5.5-6.9 mmol/L），75 g葡萄糖负荷后2小时负荷后葡萄糖140-199 mg/dL（7.7-11.0 mmol/L），血红蛋白A（1c），5.7-6.4%（39-46 mmol/mol）]），无甲状旁腺功能亢进、肾结石或高钙血症。D2 d参与者被随机分配到每日一次维生素D-3（胆钙化醇4，000 IU）或安慰剂组，并平均随访3年。主要终点是研究期间通过实验室标准评估的至发生糖尿病的时间，或如果在D2 d以外诊断，则通过裁定评估。招募于2013年底开始。结论2d将测试维生素D补充剂是否安全有效地降低2型糖尿病高危人群进展为糖尿病的风险。
OBJECTIVEObservational studies suggest that vitamin D may lower the risk of type 2 diabetes. However, data from long-term trials are lacking. The Vitamin D and Type 2 Diabetes (D2d) study is a randomized clinical trial designed to examine whether a causal relationship exists between vitamin D supplementation and the development of diabetes in people at high risk for type 2 diabetes.RESEARCH DESIGN AND METHODSD2d was designed with support from a U34 planning grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The final protocol was approved by the D2d Research Group, the data and safety monitoring board, and NIDDK. Key eligibility criteria are age 30 years, BMI of 24(22.5 for Asian Americans) to 42 kg/m(2), increased risk for diabetes (defined as meeting two of three glycemic criteria for prediabetes established by the American Diabetes Association [fasting glucose 100-125 mg/dL (5.5-6.9 mmol/L), 2-h postload glucose after 75-g glucose load 140-199 mg/dL (7.7-11.0 mmol/L), hemoglobin A(1c), 5.7-6.4% (39-46 mmol/mol)]), and no hyperparathyroidism, nephrolithiasis, or hypercalcemia. D2d participants are randomized to once-daily vitamin D-3 (cholecalciferol 4,000 IU) or placebo and followed for an average of 3 years. The primary end point is time to incident diabetes as assessed by laboratory criteria during the study or by adjudication if diagnosed outside of D2d. Recruitment was initiated at the end of 2013.CONCLUSIONSD2d will test whether vitamin D supplementation is safe and effective at lowering the risk of progression to diabetes in people at high risk for type 2 diabetes.