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

囊性纤维化儿童和青少年的高血糖指数与低血糖指数混合膳食耐受性测试

• 批准号: 10700968
• 负责人: Tanicia Daley
• 金额: $ 19.56万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10700968
• 关键词: Achievement; Acute; Address; Adolescent; Adult; Age; Apoptosis; Area; Beta Cell; Blood Glucose; C-Peptide; Calories; Cell physiology; Cessation of life; Child; Clinical; Communities; Consent; Consumption; Cysteine; Cystic Fibrosis; Cystine; Data; Development; Diabetes Mellitus; Diagnosis; Diet; Dietary Intervention; Evaluation; Exposure to; Feasibility Studies; First Degree Relative; Food; Functional disorder; Glucose; Glucose Intolerance; Glutathione; Glutathione Disulfide; Glycemic Index; Goals; High Fat Diet; Hour; Hyperglycemia; Impairment; Ingestion; Insulin; Intake; Intervention; Islet Cell; Knowledge; Measurement; Mediating; Morbidity - disease rate; Non-Insulin-Dependent Diabetes Mellitus; Nutrient; Oral; Outcome; Oxidation-Reduction; Oxidative Stress; Participant; Patients; Persons; Plasma; Precipitating Factors; Procedures; Protocols documentation; Publishing; Randomized; Recurrence; Research Personnel; Research Priority; Research Project Grants; Role; Surveys; Testing; Toxic effect; Visit; Work; acceptability and feasibility; aminothiol; comorbidity; cystic fibrosis patients; cystic fibrosis related diabetes; design; dietary excess; dietary guidelines; early childhood; evidence base; glucose tolerance; indexing; insulin secretion; interest; mortality; primary endpoint; primary outcome; pulmonary function; recruit; response; secondary outcome; sugar; sweetened beverage; willingness

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.

项目总结 囊性纤维化相关糖尿病(CFRD)是最常见的并发症之一 囊性纤维化患者。与无糖尿病的慢性阻塞性肺疾病患者不同，CFRD患者有更高的 糖耐量异常引起的死亡率和肺功能下降 这往往早于CFRD的诊断。胰岛细胞持续暴露于 血糖水平升高经常被认为是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公布的数据显示，CF患者通常 食用低质量的饮食，摄入高附加糖。我们特别关注的是， 富含高血糖指数(GI)食物和含糖饮料(SSB)的饮食 可能会增加CF中的β细胞功能障碍。我们建议我们可以成功地进行一次 可行性研究，这将涉及参与者的同意和随机化，如下 方案和研究数据的收集，以及程序可接受性的评估 参与者。其次，我们预计对从这一事件中收集的结果数据的分析 可行性研究将为餐后变化之间的联系提供初步数据 在混合餐耐量测试后的葡萄糖和氧化还原失衡。为了测试这一点，我们建议 以下目标：目标1)确定开展一项 评估餐后血糖变化的随机、平衡2x2析因设计 在接触了随GI和SSB消费而变化的混合餐之后。其中几个 评估可行性的指标将包括参与者是否愿意同意和 随机化(20%拒绝)，调查人员和参与者的高度礼仪保真度(≥85%)， 参与者的高访问参与率(≥85%)和高保留率(≥80%)，以及完成 主要临床结果测量(≥90%)，以及其他。目标2)初步评估 餐后高血糖、胰岛细胞功能及胰岛素对高、低负荷反应的变化 有无SSB的青少年CF患者的GI混合餐耐量试验(MMTT)。科目 将被随机分为含糖饮料和高血糖指数两组 (SSB+HI-GI)，含糖饮料加低血糖指数(SSB+LO-GI)，不含糖 含糖饮料加高血糖指数(NSSB+HI-GI)或不含糖饮料 加使用置换块的低血糖指数(NSSB+LO-GI)。子目标2)确定是否 伴有或不伴有SSB的高与低GI MMT值与血浆变化之间存在关联 氨硫醇氧化还原失衡。