Treating early type 2 diabetes by reducing postprandial glucose excursions: A paradigm shift in lifestyle modification

项目摘要/摘要 2型糖尿病(T2D)是一种代价高昂的流行病，在美国和世界各地都是如此。通常，它是通过 逐步升级和复杂的用药方案，这对以下方面构成了挑战 依从性、成本和副作用。生活方式干预是一种潜在的可持续的、成本更低的解决方案 有积极的副作用。家长R01赠款报告称，与传统的减肥疗法相比， 以减少营养后血糖(BG)漂移为重点的干预措施在改善 代谢控制、心血管疾病风险、抑郁、赋权和糖尿病痛苦。功效是 与基线人口、心理或疾病严重程度变量无关，这表明这种方法是 适用范围广泛。目前的方案与我们以前的研究不同，因为它将是一个多中心的研究 对于更大的外部效度，个性化以更准确地反映常规护理，新适用于成人 被诊断为T2D，谁可能受益最大，将在家中自我管理，以消除需要 用于面对面接触，因此将得到更广泛的适用。 200名新诊断为T2D且尚未开始服用糖尿病药物的成年人将被随机分配 个体化用药管理或个体化营养后血糖漂移最小化 (创业板)。药物管理参与者将从他们的初级保健提供者接收药物类型， 剂量和时机，将优化治疗并将副作用降至最低。四届自办创业板 将通过允许参与者在文本或视频格式、连续 血糖或毛细血管血糖监测，以及基于他们的短信提示的时间和内容 偏好和资源。参与者将在治疗前以及治疗后3个月和12个月进行评估。 评估将包括临床(A1c、血脂、血压、体重、心血管疾病风险)、行为 (体力活动、碳水化合物摄入量)和心理社会(抑郁、赋权、糖尿病困扰) 结果。在整个12个月的研究期间，每个参与者与糖尿病相关的支出将是 被追踪到了。我们假设，在降低A1c方面，GEM将优于药物管理， 更少的糖尿病药物，更低的糖尿病相关成本，将带来更大的次要好处。 这项研究的结果有可能立即为新诊断的T2D患者和他们的 初级保健提供者提供了一种新的、具有成本效益的生活方式干预选择。它还可以引导研究人员向 研究创业板的影响及其潜在机制的维持(如降低胰岛素抵抗， 葡萄糖毒性，改善胰岛素的产生)。

Project Summary/Abstract Type 2 diabetes (T2D) is a costly epidemic, both in the U.S. and worldwide. Typically, it is managed with a progressively escalating and complicated medication regimen, which presents challenges with respect to adherence, cost, and side-effects. Lifestyle interventions are a potentially sustainable, less expensive solution with positive side effects. The parent R01 grant reported that, compared to conventional weight loss therapy, an intervention that focuses on reducing post-nutrient blood glucose (BG) excursions is effective at improving metabolic control, risk for cardiovascular disease, depression, empowerment and diabetes distress. Efficacy was unrelated to baseline demographic, psychological or disease severity variables, suggesting this approach is broadly applicable. The current proposal differs from our previous research in that it will be a multi-center study for greater external validity, individualized to more accurately reflect routine care, applied to adults newly diagnosed with T2D, who may benefit the most, and it will be self-administered at home to eliminate the need for face-to-face contact and consequently will be more broadly applicable. 200 adults who are newly diagnosed with T2D and have not begun taking diabetes medication will be randomized to individualized medication management or to individualized post-nutrient glucose excursion minimization (GEM). Medication management participants will receive from their primary care provider the medication types, doses and timing that will optimize treatment and minimize side effects. The 4-session, self-administered GEM will be individualized by allowing participants to choose between a text or video format, between continuous glucose or capillary BG monitoring, and the timing and content of text-message prompts based on their preference and resources. Participants will be assessed before, and at both 3 and 12 months post-treatment. Assessments will include clinical (A1c, lipids, blood pressure, weight, risk of cardiovascular disease), behavioral (physical activity, carbohydrate intake) and psychosocial (depression, empowerment, diabetes distress) outcomes. Throughout the 12-month study period, each participant’s diabetes-related expenditures will be tracked. We hypothesize that GEM will be superior to medication management in terms of reducing A1c, with less diabetes medication, lower diabetes-related cost, and will lead to greater secondary benefits. The results of this study have the potential to immediately provide patients newly diagnosed with T2D and their primary care providers a new, cost-effective lifestyle intervention option. It could also direct researchers toward investigating the maintenance of GEM’s impact and its underlying mechanisms (e.g. reducing insulin resistance, glucose toxicity, improving insulin production).