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: 10453251
• 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/10453251
• 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; Deltastab; 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; 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.

项目概要 囊性纤维化相关糖尿病（CFRD）是最常见的合并症之一 囊性纤维化患者。与没有糖尿病的 CF 患者不同，CFRD 患者的患病率更高 葡萄糖耐量异常导致死亡率和肺功能下降 通常早于 CFRD 的诊断。胰岛细胞持续适度暴露于 血糖水平升高通常被认为是β细胞功能障碍的重要原因。 我们成人 CF 中心和其他机构最近发布的数据表明，CF 患者经常 摄入高添加糖的低质量饮食。我们特别担心的是 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。我们建议我们能够成功地开展一次 可行性研究，其中将涉及参与者的同意和随机化，以下内容 方案的制定和研究数据的收集，以及对程序可接受性的评估 参与者。其次，我们预计对由此收集的结果数据进行分析 可行性研究将提供餐后变化之间关联的初步数据 混合膳食耐受性测试后葡萄糖和氧化还原失衡。为了测试这一点，我们建议 目标如下： 目标 1) 确定开展一项研究的可行性和可接受性 评估餐后血糖变化的随机、平衡 2x2 因子设计 接触因 GI 和 SSB 摄入量而异的混合膳食后。其中一些 评估可行性的指标将包括参与者同意并接受的意愿 随机（<20% 拒绝），研究人员和参与者之间的方案保真度高 (≥85%)， 参与者的高访问出席率（≥85%）和高保留率（≥80%），以及完成 主要临床结果测量（≥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反应的变化 患有 CF 的青少年在有或没有 SSB 的情况下进行胃肠道混合膳食耐受性试验 (MMTT)。科目 将同样随机分配到含糖饮料加高血糖指数 (SSB+HI-GI)、低血糖指数含糖饮料(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 加上使用排列块的低血糖指数 (NSSB+LO-GI)。子目标 2) 确定是否 有或没有 SSB 的高 GI MMTT 与低 GI MMTT 与血浆变化之间存在关联 氨基硫醇氧化还原失衡。