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; 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.

项目摘要 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患者的患者较高 由于葡萄糖耐受性异常，死亡率和肺功能下降 这通常早于CFRD的诊断。胰岛细胞持续暴露于适度的 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中心的最新发布数据表明，患有CF的患者经常 消耗高质量的饮食，并添加高糖摄入量。我们特别担心 高血糖指数（GI）食品和糖甜床（SSB）丰富的饮食 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 可行性研究将涉及参与者的同意和随机化，以下 协议和研究数据的收集，以及对程序可接受性的评估 参与者。次要，我们预计从中收集的结果数据的分析 可行性研究将允许餐后变化之间关联的初步数据 在葡萄糖和氧化还原耐受性测试后。为了测试这一点，我们建议 以下目的：目标1）确定进行A的可行性和可接受性 随机，平衡的2x2阶乘设计，评估葡萄糖的餐后变化 在暴露于混合餐的情况下，与SSB的消费不同。一些 评估可行性的指标将包括参与者同意的意愿，并成为 随机（<20％拒绝），研究人员和参与者之间的高方案保真度（≥85％）， 参与者（≥85％）和高保留率（≥80％）以及完成 主要的临床结果测量（≥90％）等。目标2）评估初步 餐后高血糖，胰岛细胞功能的变化以及对高或低的反应 在患有CF的青少年中，GI混合饮食耐受性测试（MMTT）。主题 将同样随机分配给糖甜卧室以及高血糖指数 （SSB+HI-GI），糖甜床和低血糖指数（SSB+LO-GI），无糖 甜床上加高血糖指数（NSSB+HI-GI）或无糖甜床 加上使用置换块的低血糖指数（NSSB+LO-GI）。子目标2）确定是否 与SSB有和没有等离子变化的高gi mmtt之间存在关联 氨基硫醇氧化还原不平衡。