Personalized Dietary Management in Type 2 Diabetes

摘要 2型糖尿病（T2 D）的高血糖症与多种血管并发症有关，但 旨在达到接近正常HbA 1c的药物治疗方案的临床试验令人失望， 甚至会增加因多种药物治疗而产生不良后果的风险。加强行为管理， 餐后血糖控制可以进一步降低血糖暴露和下游效应， 多药疗法餐后腹泻主要是由饮食摄入量驱动的，但关于最佳饮食的研究结果表明， 限制血糖暴露的饮食方法好坏参半，大多数是消极的。到目前为止，已经进行的研究使用了 一刀切的饮食方案，没有考虑到血糖反应是高血糖的事实， 单独的.在本项255例（85例/组）早期T2 D患者的临床试验中，受试者将被随机分组 （1）以社会认知理论为基础的行为生活方式干预，包括一种一刀切的 地中海ADA饮食（以下简称标准化），（2）标准化加个性化饮食指导， 最大限度地减少餐后血糖反应（以下称为个性化），或（3）饮食护理控制加 （以下简称UCC）。我们将比较各组的血糖波动平均幅度（法师）。 假设6个月时MAGE个性化<MAGE标准化< MAGEUCC。在每个时间点，我们将描述 HbA 1c、β细胞功能的组间差异，以及是否需要升级药物治疗方案。我们也 将描述干预对血糖变异性的替代测量的影响（标准偏差， 连续整体净糖化作用、曲线下面积以及超出范围和严重超出范围的频率- 范围葡萄糖值）。我们将探讨GV和HbA 1c对观察到的β- 细胞功能拟议的研究是一项综合性的科学事业，反映了护理专家的投入， 行为科学、计算生物学、微生物组、移动健康技术、内分泌学和营养学 发展个性化的行为咨询，以尽量减少血糖暴露和疾病 早期T2 D患者的进展。

Abstract Hyperglycemia in type 2 diabetes (T2D) is associated with a variety of vascular complications of the disease, but clinical trials of medication regimens designed to achieve near-normal HbA1c have been disappointing and may even increase the risk of adverse outcomes due to polypharmacy. Enhancing behavioral management of postprandial glycemia can further reduce glycemic exposure and downstream effects without the risks of polypharmacy. Postprandial glycemia is largely driven by dietary intake, but research findings regarding the best dietary approach to limit glycemic exposure are mixed and mostly negative. Studies done, to-date, have used one-size-fits-all dietary regimens that do not take into consideration the fact that glycemic response is highly individual. In this clinical trial of 255 (85/group) individuals with early-stage T2D, participants will be randomized to: (1) a Social Cognitive Theory-based behavioral lifestyle intervention that includes a one-size-fits-all Mediterranean ADA diet (hereafter Standardized), (2) Standardized plus personalized dietary guidance to minimize postprandial glycemic response to meals (hereafter Personalized), or (3) a Usual Care Control plus (hereafter UCC). We will compare the groups in terms of mean amplitude of glycemic excursion (MAGE). Hypothesis MAGEPersonalized< MAGEStandardized < MAGEUCC at 6 months. At each time point we will describe between group differences in HbA1c, β-cell function, and the need to escalate the medication regimen. We also will describe the impact of the interventions on alternative measures of glycemic variability (standard deviation, Continuous Overall Net Glycemic Action, area under the curve, and frequency of out-of-range and seriously out- of-range glucose values). We will explore the relative contribution of GV and HbA1c to observed changes in β- cell function. The proposed study is an integrative scientific undertaking, reflecting the input of experts in nursing, the behavioral sciences, computational biology, microbiome, mHealth technology, endocrinology, and nutrition for the development of personalized behavioral counseling to minimize glycemic exposure and disease progression in those with early-stage T2D.