Personalized Dietary Management in Type 2 Diabetes

2 型糖尿病的个性化饮食管理

• 批准号: 10526427
• 负责人: Eran Segal
• 金额: $ 68.99万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-15 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10526427
• 关键词: Address; Affect; Algorithms; Amputation; Area; Area Under Curve; Behavioral; Behavioral Sciences; Beta Cell; Blood Glucose; Blood Vessels; Blood capillaries; Cardiovascular system; Cell physiology; Clinical Trials; Computational Biology; Counseling; Dementia; Deterioration; Development; Diabetic Diet; Diet; Dietary Intervention; Dietary intake; Discipline of Nursing; Disease; Disease Progression; Education; Educational Materials; Endocrinology; Epidemic; Failure; Food; Frequencies; Frustration; Glucose; Glycosylated hemoglobin A; Goals; Health Technology; Heart Diseases; Hyperglycemia; Hypoglycemia; Individual; Intervention; Intervention Studies; Investigation; Kidney Diseases; Malignant Neoplasms; Measurement; Measures; Mediating; Mediterranean Diet; Metabolic; Modeling; Molecular Profiling; Nature; Non-Insulin-Dependent Diabetes Mellitus; Nutritional; Nutritional Study; Participant; Patients; Performance; Persons; Pharmaceutical Preparations; Polypharmacy; Randomized; Recommendation; Regimen; Research; Research Priority; Retinal Diseases; Risk; Schedule; Self Efficacy; Self Management; Standardization; Strategic Planning; Stroke; Technology; Time; United States; United States National Institutes of Health; Variant; adverse outcome; design; dietary; dietary approach; disorder risk; efficacy evaluation; experience; genetic testing; glucose monitor; glycemic control; gut microbiome; lifestyle intervention; mHealth; machine learning algorithm; medication compliance; microbiome; nutrition; personalized intervention; personalized medicine; preservation; randomized trial; response; social cognitive theory; success; treatment as usual

Abstract Hyperglycemia in type 2 diabetes (T2D) is associated with a variety of vascular complications of the disease, but clinical trials of medication regimens designed to achieve near-normal HbA1c have been disappointing and may even increase the risk of adverse outcomes due to polypharmacy. Enhancing behavioral management of postprandial glycemia can further reduce glycemic exposure and downstream effects without the risks of polypharmacy. Postprandial glycemia is largely driven by dietary intake, but research findings regarding the best dietary approach to limit glycemic exposure are mixed and mostly negative. Studies done, to-date, have used one-size-fits-all dietary regimens that do not take into consideration the fact that glycemic response is highly individual. In this clinical trial of 255 (85/group) individuals with early-stage T2D, participants will be randomized to: (1) a Social Cognitive Theory-based behavioral lifestyle intervention that includes a one-size-fits-all Mediterranean ADA diet (hereafter Standardized), (2) Standardized plus personalized dietary guidance to minimize postprandial glycemic response to meals (hereafter Personalized), or (3) a Usual Care Control plus (hereafter UCC). We will compare the groups in terms of mean amplitude of glycemic excursion (MAGE). Hypothesis MAGEPersonalized< MAGEStandardized < MAGEUCC at 6 months. At each time point we will describe between group differences in HbA1c, β-cell function, and the need to escalate the medication regimen. We also will describe the impact of the interventions on alternative measures of glycemic variability (standard deviation, Continuous Overall Net Glycemic Action, area under the curve, and frequency of out-of-range and seriously out- of-range glucose values). We will explore the relative contribution of GV and HbA1c to observed changes in β- cell function. The proposed study is an integrative scientific undertaking, reflecting the input of experts in nursing, the behavioral sciences, computational biology, microbiome, mHealth technology, endocrinology, and nutrition for the development of personalized behavioral counseling to minimize glycemic exposure and disease progression in those with early-stage T2D.

摘要 2型糖尿病(T2D)的高血糖与该疾病的各种血管并发症有关，但 旨在使HbA1c接近正常的药物方案的临床试验一直令人失望，可能 甚至增加了因多药联用而产生不良后果的风险。加强员工的行为管理 餐后血糖可以进一步减少血糖暴露和下游影响，而不会有以下风险 综合药房。餐后血糖在很大程度上是由饮食摄入量驱动的，但关于最佳饮食的研究发现 限制血糖暴露的饮食方法有多种，而且大多是负面的。到目前为止，已经进行的研究使用了 一刀切的饮食方案，没有考虑到这样一个事实，即血糖反应高度 个人的。在这项对255名(85人/组)早期T2D患者进行的临床试验中，参与者将被随机分组 TO：(1)基于社会认知理论的行为生活方式干预，包括一刀切 地中海ADA饮食(此后标准化)，(2)标准化加个性化饮食指导，以 最大限度地减少餐后血糖反应(此后个性化)，或(3)常规护理控制加 (以下简称UCC)。我们将根据血糖漂移的平均幅度(MAGE)对两组进行比较。 假设MAGE在6个月时个性化和标准化&MAGEUCC。在每个时间点，我们将描述 两组间在糖化血红蛋白、β细胞功能方面的差异，以及是否需要升级用药方案。我们也 将描述干预措施对血糖变异性(标准差， 连续的总体净血糖作用、曲线下面积以及超出范围和严重超出范围的频率- 范围外的血糖值)。我们将探索GV和HbA1c对观察到的β变化的相对贡献。 细胞功能。这项拟议的研究是一项综合性的科学事业，反映了护理专家的投入， 行为科学、计算生物学、微生物学、移动健康技术、内分泌学和营养学 用于开发个性化行为咨询，以将血糖暴露和疾病降至最低 早期T2D患者的进展情况。