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

基本信息

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
项目类别：
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

项目摘要

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).

项目概要/摘要 2 型糖尿病 (T2D) 在美国和世界范围内都是一种代价高昂的流行病，通常通过以下方法进行管理。逐渐升级和复杂的药物治疗方案，这对以下方面提出了挑战生活方式干预是一种潜在可持续且成本较低的解决方案。母公司 R01 资助报告称，与传统的减肥疗法相比，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。与基线人口、心理或疾病严重程度变量无关，表明这种方法是目前的建议与我们之前的研究不同，因为它将是一项多中心研究。为了获得更大的外部有效性，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 T2D 的人可能受益最多，并且可以在家自我管理以消除需要面对面接触，因此将得到更广泛的应用。 200 名新诊断患有 T2D 且尚未开始服用糖尿病药物的成年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其初级保健提供者处获得药物类型，剂量和时间安排将优化治疗并最大限度地减少副作用 4 个疗程的自我管理 GEM。将通过允许在文本或视频格式、连续格式之间进行选择来实现个性化血糖或毛细血管血糖监测，并根据其短信提示的时间和内容参与者的偏好和资源将在治疗前、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）和社会心理（抑郁、赋权、糖尿病困扰）在整个 12 个月的研究期间，每个参与者的糖尿病相关支出将是我们追踪发现，在降低 A1c 方面，GEM 优于药物管理。减少糖尿病药物治疗，降低糖尿病相关费用，并将带来更大的次要效益。这项研究的结果有可能立即为新诊断为 T2D 的患者及其患者提供帮助。它也可以为初级保健提供者提供一种新的、具有成本效益的生活方式干预选择。研究 GEM 影响的维持及其潜在机制（例如减少胰岛素抵抗、葡萄糖毒性，改善胰岛素的产生）。