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

基本信息

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
项目类别：
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

项目摘要

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这通常早于 CFRD 的诊断。胰岛细胞持续适度暴露于环境中。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 患者经常我们特别关注的是低质量饮食和高添加糖摄入量。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。可行性研究，其中将涉及以下内容的同意和随机化协议和研究数据的收集，以及程序可接受性的评估其次，我们预计将从参与者那里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为了测试这一点，我们建议进行混合膳食耐受性测试后的葡萄糖和氧化还原失衡。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。评估可行性的指标将包括同意的意愿和随机（<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) 评估初步结果。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 的青少年有或没有 SSB 的胃肠道混合膳食耐受性测试 (MMTT)。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。