富含维生素 D3 的酸奶饮料对 2 型糖尿病患者维生素 D 受体基因多态性的人体测量、代谢、炎症和氧化应激生物标志物的影响：一项随机对照临床试验研究方案。
Efficacy of vitamin D3-fortified-yogurt drink on anthropometric, metabolic, inflammatory and oxidative stress biomarkers according to vitamin D receptor gene polymorphisms in type 2 diabetic patients: a study protocol for a randomized controlled clinical trial.
机构信息
Department of Nutrition and Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS), Tehran, Iran.
出版信息
BMC Endocr Disord. 2011 Jun 22;11:12. doi: 10.1186/1472-6823-11-12.
BACKGROUND
Development of type 2 diabetes mellitus (T2DM) is determined by the interactions of genetic and environmental factors. This study was designed to evaluate the possible role of VDR single nucleotide polymorphisms (SNPs) on different aspects of diabetic host response (anthropometric, metabolic, oxidative stress and inflammatory) to daily intake of vitamin D through fortified yogurt drink for 12 weeks.
METHODS/DESIGN: This study comprises two parts: (i) a case-control study; and (ii) an intervention trial. In the first part, VDR polymorphisms (Taq1, FokI, Apa1, Bsm1, and Cdx2) are determined in 350 T2DM patients and 350 non-diabetic subjects. In the second part, the possible effects of daily intake of two servings of vitamin D3-fortified yogurt drink (FYD; 500 IU vitamin D/250 mL) on some selected metabolic (including insulin resistance), inflammatory and oxidative stress biomarkers in 135 T2DM patients are assessed. To relate the resulted changes in the biomarkers to vitamin D replenishment, another group of diabetic patients (n = 45) are also included in the study who receive 2 servings of plain yogurt drink (PYD) a day. The primary outcome is serum level of 25(OH) D, which it is expected to be elevated only in FYD group. Secondary outcomes include improvements in glycemic, metabolic, inflammatory and oxidative stress biomarkers in FYD group compared to PYD group. Three VDR FokI polymorphisms are determined only in FYD group followed by comparison of changes in the biomarkers among these genotypic variants.
DISCUSSION
The present study, at least in part, elucidates the discrepancies in the results of different vitamin D-diabetes studies pertaining to the genetic variations of the population. If VDR polymorphisms are found to influence the response to our intervention, then knowing distribution of VDR polymorphisms in both diabetic and non-diabetic populations can give a picture of the proportion of the community in whom up to 1000 IU/d vitamin D may not be effective enough to improve insulin resistance and related morbidities. Therefore, they should ideally receive further nutritional support according to their genotype.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT01236846.
背景
2 型糖尿病（T2DM）的发展取决于遗传和环境因素的相互作用。本研究旨在评估 VDR 单核苷酸多态性（SNPs）在每日摄入强化酸奶饮料 12 周后对糖尿病宿主反应（人体测量、代谢、氧化应激和炎症）的不同方面的可能作用。
方法/设计：本研究包括两部分：（i）病例对照研究；和（ii）干预试验。在第一部分中，在 350 例 T2DM 患者和 350 例非糖尿病患者中确定 VDR 多态性（Taq1、FokI、Apa1、Bsm1 和 Cdx2）。在第二部分中，评估每日摄入两份维生素 D3 强化酸奶饮料（FYD；500 IU 维生素 D/250 mL）对 135 例 T2DM 患者某些选定的代谢（包括胰岛素抵抗）、炎症和氧化应激生物标志物的可能影响。为了将生物标志物的变化与维生素 D 的补充相关联，另一组 45 例糖尿病患者也纳入研究，他们每天接受两份普通酸奶饮料（PYD）。主要结局是血清 25（OH）D 水平，预计仅 FYD 组升高。次要结局包括 FYD 组与 PYD 组相比，血糖、代谢、炎症和氧化应激生物标志物的改善。仅在 FYD 组中确定三个 VDR FokI 多态性，然后比较这些基因型变异体之间生物标志物的变化。
讨论
本研究至少部分阐明了不同维生素 D-糖尿病研究结果之间存在差异的原因，这与人群的遗传变异有关。如果 VDR 多态性被发现影响我们干预的反应，那么了解糖尿病和非糖尿病人群中 VDR 多态性的分布，可以了解社区中多大比例的人每天摄入 1000 IU 维生素 D 可能不足以改善胰岛素抵抗和相关的发病率。因此，根据他们的基因型，他们应该理想地接受进一步的营养支持。
试验注册
ClinicalTrials.gov：NCT01236846。
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