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

通过减少餐后血糖波动来治疗早期 2 型糖尿病：改变生活方式的范式转变

• 批准号: 10517020
• 负责人: Daniel Joseph Cox
• 金额: $ 73.27万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10517020
• 关键词: Adherence; Adipose tissue; Adult; Aftercare; Algorithms; American; Area Under Curve; Behavioral; Blood Glucose; Blood Pressure; Blood capillaries; Body Weight decreased; Body mass index; Calories; Carbohydrates; Clinical; Complex; Consent; Continuous Capillary; Cost of Illness; Diabetes Mellitus; Diet; Disease Progression; Dose; Economics; Epidemic; Expenditure; Family; Fatty acid glycerol esters; Feedback; Glucose; Glycosylated hemoglobin A; Grant; Health; Health Benefit; Healthcare Systems; High Density Lipoproteins; Home; Hyperglycemia; Individual; Individual Differences; Ingestion; Injectable; Insulin; Insulin Resistance; Intake; Internet; Intervention; Learning; Life Style Modification; Lipids; Liver; Maintenance; Manuals; Medication Management; Mental Depression; Metabolic Control; Metformin; Modification; Morbidity - disease rate; Multicenter Studies; Newly Diagnosed; Non-Insulin-Dependent Diabetes Mellitus; Nutrient; Oral; Outcome; Pancreas; Parents; Participant; Patient Preferences; Patients; Persons; Pharmaceutical Preparations; Pharmacology; Pharmacotherapy; Physical activity; Physiological; Pilot Projects; Production; Public Health; Randomized; Reading; Recovery; Regimen; Reporting; Research; Research Personnel; Resources; Self Administration; Severity of illness; Skeletal Muscle; Standardization; Text; Text Messaging; Time; Toxic effect; Weight; Work; base; blood glucose regulation; cardiovascular disorder risk; cardiovascular risk factor; care providers; cost; cost effective; depressive symptoms; diabetes distress; diabetes management; diaries; diet and exercise; effective therapy; efficacy evaluation; empowered; empowerment; glucose monitor; improved; innovation; lifestyle intervention; medication compliance; mortality; optimal treatments; pandemic disease; preference; prevent; programs; psychologic; psychosocial; routine care; side effect; social; success; treatment optimization; trial design; user-friendly; weight loss intervention

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).

项目总结/摘要 2型糖尿病（T2 D）是一种昂贵的流行病，在美国和世界范围内。通常，它是用 逐渐升级和复杂的药物治疗方案，这对 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，成本较低的解决方案 有积极的副作用父母R 01补助金报告说，与传统的减肥疗法相比， 一种专注于减少营养后血糖（BG）波动的干预措施可有效改善 代谢控制、心血管疾病风险、抑郁、赋权和糖尿病困扰。疗效 与基线人口统计学、心理学或疾病严重程度变量无关，表明这种方法是 广泛适用。目前的建议与我们以前的研究不同，因为它将是一项多中心研究 为了获得更大的外部效度，个性化以更准确地反映常规护理，新应用于成人 被诊断患有T2 D，谁可能受益最大，它将在家里自我管理，以消除需要 用于面对面接触，因此将更广泛地应用。 200名新诊断为T2 D且尚未开始服用糖尿病药物的成人将被随机分组 个体化药物管理或个体化营养后血糖波动最小化 （GEM）。药物管理参与者将从他们的初级保健提供者那里收到药物类型， 剂量和时间，将优化治疗和最小化副作用。4个交易日，自我管理的创业板 将通过允许参与者选择文本或视频格式，连续 血糖或毛细血管血糖监测，以及基于其 偏好和资源。将在治疗前以及治疗后3个月和12个月对受试者进行评估。 评估将包括临床（A1 c、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）和社会心理（抑郁、赋权、糖尿病困扰） 结果。在整个12个月的研究期间，每位参与者的糖尿病相关支出将 追踪.我们假设GEM在降低A1 c方面上级药物治疗， 减少糖尿病药物治疗，降低糖尿病相关费用，并将带来更大的次级效益。 这项研究的结果有可能立即为新诊断为T2 D的患者及其治疗提供帮助。 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。它还可以指导研究人员 研究GEM的影响及其潜在机制（例如减少胰岛素抵抗， 葡萄糖毒性，改善胰岛素产生）。