High vs Low Glycemic Index Mixed Meal Tolerance Test in Children and Adolescents with Cystic Fibrosis

项目摘要 囊性纤维化相关糖尿病（CFRD）是糖尿病患者中最常见的并发症之一， 囊性纤维化患者。与无糖尿病的CF患者不同，CFRD患者的 由于葡萄糖耐量异常导致的死亡率和肺功能下降 往往早于面板堆石坝的诊断。胰岛细胞持续暴露于 血糖水平升高通常被认为是β细胞功能障碍的重要原因。 我们的成人CF中心和其他机构最近发表的数据显示，CF患者通常 食用低质量的饮食，摄入高添加糖。我们特别关切的是， 富含高血糖指数（GI）食物和含糖饮料（SSB）的饮食 可能增加CF中的β细胞功能障碍。我们建议，我们可以成功地进行一个 可行性研究，其中将涉及参与者的同意和随机化， 方案和研究数据收集，以及从 参与者其次，我们预计，从这一点收集的结果数据的分析， 可行性研究将提供餐后变化之间关联的初步数据， 在混合餐耐量试验后出现葡萄糖和氧化还原失衡。为了验证这一点，我们建议 目标1）确定开展一项 评价餐后血糖变化的随机、平衡2x2析因设计 暴露于混合餐（因GI和SSB摄入量而异）后。几个 评估可行性的指标将包括参与者同意的意愿， 随机化（<20%拒绝），研究者和参与者之间的高方案忠诚度（≥85%）， 参与者的高访视出席率（≥85%）和高保留率（≥80%），以及 主要临床结局测量（≥90%）等。目标2）初步评估 餐后高血糖、胰岛细胞功能和肠促胰岛素对高或低血糖的反应的变化 在青少年CF患者中进行GI混合餐耐受试验（MMTT）（含和不含SSB）。科目 将被平等随机分配到含糖饮料加高血糖指数组 (SSB+HI-GI），加糖饮料加低血糖指数（SSB+LO-GI），无糖 加糖饮料加高血糖指数（NSSB+HI-GI）或无糖加糖饮料 加上低血糖指数（NSSB+LO-GI）。子目标2）确定 在伴有和不伴有SSB的高GI MMTT与低GI MMTT之间存在相关性， 氨基硫醇氧化还原失衡。

PROJECT SUMMARY Cystic fibrosis related diabetes (CFRD) is one of the most common co-morbidities seen in patients with cystic fibrosis. Unlike CF patients without diabetes, CFRD patients have a higher mortality rates and a decline in pulmonary function due to abnormalities in glucose tolerance that often predate the diagnosis of CFRD. Sustained exposure of the islet cell to modestly elevated blood glucose levels is often cited as an important cause of beta cell dysfunction. Recent published data from our adult CF center and others show that patients with CF often consume a low-quality diet with high added sugar intake. We are particularly concerned that a diet which is abundant in high glycemic index (GI) foods and sugar sweetened beverages (SSB) may increase beta cell dysfunction in CF. We propose that we can successfully conduct a feasibility study, which will involve the consenting and randomizing of participants, the following of protocols and gathering of study data, and an evaluation of procedural acceptability from participants. Secondarily, we anticipate that an analysis of outcome data collected from this feasibility study will allow for preliminary data of the association between postprandial changes in glucose and redox imbalance following a mixed meal tolerance test. To test this, we propose the following Aims: Aim 1) Determine the feasibility and acceptability of conducting a randomized, balanced 2x2 factorial design that evaluates postprandial changes in glucose following exposure to a mixed meal that varies by GI and consumption of a SSB. A few of the metrics to evaluate feasibility will include a willingness from participants to consent and be randomized (<20% refusal), high protocol fidelity among investigators and participants (≥85%), high visit attendance by participants (≥85%) and high retention (≥80%), and completion of the primary clinical outcome measurements (≥90%), among others. Aim 2) Evaluate preliminary changes in postprandial hyperglycemia, islet cell function and incretin response to a high or low GI mixed meal tolerance test (MMTT) with and without SSBs in adolescents with CF. Subjects will be equally randomized to either sugar sweetened beverage plus high glycemic index (SSB+HI-GI), sugar sweetened beverage plus low glycemic index (SSB+LO-GI), no sugar sweetened beverage plus high glycemic index (NSSB+HI-GI), or no sugar sweetened beverage plus low glycemic index (NSSB+LO-GI) using permuted blocks. Sub Aim 2) Determine if an association exists between high vs. low GI MMTT with and without SSB and changes in plasma aminothiol redox imbalance.