Time Restricted Eating As a Viable Alternative to Caloric Restriction for Treating Hyperglycemia in a Population with Type 2 (T2DM) diabetes

摘要 在PAS-20-160“针对疾病的临床试验小型R 01”的支持下， NIDDK，“我们将进行可行性研究，以测试我们的总体假设，即TRE提出了一个可行的 作为热量限制的替代品，可改善血糖测量并减轻体重， 超重/肥胖患者[BMI：25-35 kg/m2]，仅接受二甲双胍治疗的2型糖尿病（T2 DM）。的 这项研究的基本原理来自于观察，即有意的热量限制在以下方面起着不可或缺的作用： 新诊断/早期T2 DM患者的血糖管理。然而，有意的热量限制是 由于存在多重障碍，包括在获得必要的技术援助方面遇到的挑战， 知识、教学干预、交付成本和对生活质量的潜在负担。相比 有意识地限制卡路里，时间限制饮食（TRE），重点是限制饮食窗口。这 饮食的简化视图允许参与者在每天的时间内根据他们的饮食偏好随意进食 frame. TRE与非T2 DM患者的体重减轻相关，并改善T2 DM患者的血糖测量结果。 糖尿病前期患者，但其对血糖测量的影响，特别是考虑体重时 T2 DM患者的变化仍未知。 本研究将涉及TRE与热量限制的24周干预（共n=56，每组n=28） 这将是工作人员监督的12个星期和自我维持的12个星期。我们将利用创新的 诸如基于缩放虚拟访问、基于移动的电话的食物记录、用于 每周体重、持续血糖监测和活动记录仪，以实施我们的干预措施并评估 结果。我们的具体目标包括：目标#1：比较TRE与热量限制对血糖的影响。 目标#2：比较TRE与热量限制对体重的影响，目标#3：比较TRE与热量限制对体重的影响。 TRE与热量限制干预负担。本次可行性研究的影响和意义在于， 提供初步数据，以支持TRE治疗高血糖症的确定性随机对照试验， T2 DM患者。

ABSTRACT With the support of PAS-20-160 “Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK,” we will perform a feasibility study to test our overall hypothesis that TRE presents a viable alternative to caloric restriction for improving glycemic measures and reducing weight in overweight/obese patients [BMI:25-35 kg/m2] with metformin-only treated Type 2 diabetes (T2DM). The rationale for this study arises from the observation that intentional caloric restriction plays an integral part in glycemic management in patients with newly diagnosed/early-stage T2DM. Yet intentional caloric restriction is difficult to sustain due to multiple barriers, including challenges arising from acquiring the necessary knowledge, teaching the intervention, cost of delivery and potential burden on quality of life. In contrast to intentionally restricting calories, time restricted eating (TRE), focuses on restricting the eating window. This simplified view of eating allows participants to eat ad libitum per their dietary preferences during a daily time frame. TRE is associated with weight loss in patients without T2DM and improves glycemic measures in patients with prediabetes, however its effects on glycemic measures, especially when accounting for weight change, in patients with T2DM remains unknown. This study will involve a 24-week intervention of TRE vs Caloric Restriction (n=56 total, n=28 per group) which will be staff supervised for 12 weeks and self-maintained for 12 weeks. We will use innovative state of the art technology such as Zoom-based virtual visits, mobile phone-based food record, wifi-enabled scale for weekly weights, continuous glucose monitoring and actigraphy to implement our interventions and assess outcomes. Our Specific Aims include: Aim #1: Compare the effect of TRE vs Caloric Restriction on glycemic measures, Aim#2: Compare the effect of TRE vs Caloric Restriction on weight, Aim #3: Compare the effect of TRE vs Caloric Restriction on intervention burden. The impact and significance of this feasibility study is to provide preliminary data to support a definitive randomized controlled trial of TRE to treat hyperglycemia in patients with T2DM.