Personalized Dietary Management in Type 2 Diabetes

2 型糖尿病的个性化饮食管理

基本信息

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
项目类别：
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

项目摘要

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.

抽象的 2 型糖尿病 (T2D) 中的高血糖与该疾病的多种血管并发症相关，但是旨在实现接近正常 HbA1c 的药物治疗方案的临床试验令人失望，并且可能加强多药治疗甚至会增加不良后果的风险。餐后血糖可以进一步降低血糖暴露和下游影响，而不存在以下风险：餐后血糖很大程度上是由饮食摄入引起的，但研究结果表明最好的治疗方法。限制血糖暴露的饮食方法多种多样，迄今为止所做的研究大多是负面的。一刀切的饮食方案没有考虑到血糖反应高度这一事实在这项对 255 名（85 名/组）早期 T2D 患者进行的临床试验中，参与者将被随机分组。 (1) 基于社会认知理论的行为生活方式干预，其中包括一刀切的方法地中海 ADA 饮食（以下简称标准化），(2) 标准化加个性化饮食指导尽量减少餐后血糖反应（以下简称个性化），或 (3) 常规护理控制加（以下简称 UCC）我们将根据血糖波动的平均幅度 (MAGE) 来比较各组。假设 MAGEPersonalized< MAGEStandardized < MAGEUCC 在 6 个月时，我们将描述每个时间点。我们还研究了 HbA1c、β 细胞功能以及升级药物治疗方案的需要之间的组间差异。将描述干预措施对血糖变异性替代指标（标准差、连续总体净血糖作用、曲线下面积以及超出范围和严重超出范围的频率我们将探讨 GV 和 HbA1c 对观察到的 β- 变化的相对贡献。拟议的研究是一项综合科学事业，反映了护理专家的投入，行为科学、计算生物学、微生物组、移动医疗技术、内分泌学和营养学开发个性化行为咨询，以尽量减少血糖暴露和疾病早期 T2D 患者的进展。