Structured Exercise in Obese Diabetic Patients with Chronic Kidney Disease: A Ran

肥胖糖尿病慢性肾病患者的结构化运动：A Ran

• 批准号: 8856555
• 负责人: Eileen G Collins
• 金额: --
• 依托单位: EDWARD HINES JR VA HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8856555
• 关键词: Address; Adherence; Aerobic; Aerobic Exercise; Albuminuria; Blood Pressure; Body Composition; Body Weight; Body Weight decreased; C-reactive protein; Cardiovascular system; Caring; Cholesterol; Chronic Kidney Failure; Comorbidity; Cost Savings; Cost of Illness; Data; Diabetes Mellitus; Diabetic Nephropathy; Dilatation - action; Disease; End stage renal failure; Energy Metabolism; Epidemiologic Studies; Etiology; Evaluation; Exercise; Exercise Tolerance; Fatty acid glycerol esters; Feasibility Studies; Glomerular Filtration Rate; Glycosylated Hemoglobin; Health; Health Expenditures; Heart Rate; Home environment; Human; Inflammation; Kidney; Lead; Lipids; Malondialdehyde; Measures; Mediating; Medical; Medicare; Mental Depression; Modality; Monitor; Morbidity - disease rate; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Outcome; Outcome Study; Oxidative Stress; Patient Care; Patients; Perception; Plasma; Population; Preparation; Prevention; Proteinuria; Quality of life; Randomized; Randomized Controlled Trials; Reduced Glutathione; Renal Replacement Therapy; Renal dialysis; Renal function; Rest; Running; Staging; Structure; Training; Urine; Veterans; abstracting; blood glucose regulation; cost; diabetic; diabetic patient; endothelial dysfunction; fitness; health related quality of life; high risk; improved; indexing; mortality; novel; patient population; primary outcome; programs; secondary outcome; telehealth

DESCRIPTION (provided by applicant): Abstract: Structured exercise in obese diabetic patients with chronic kidney disease: a randomized controlled trial. Patients with type 2 diabetes, obesity, and chronic kidney disease (CKD) are generally physically inactive, have a high mortality rate, and may benefit from an exercise program. However, there have been no randomized controlled trials to determine the benefits of exercise training in this population. This study seeks to substantiate the hypothesis that increasing energy expenditure by exercise training in the obese diabetic patient with CKD will result in the following benefits: 1. Renal benefits, including reduction in proteinuria and stabilization of glomerular filtration rate (GFR) 2. Cardiovascular benefits, including decreased blood pressure, decreased heart rate, and increased exercise tolerance. 3. Improved glucose control (lower glycated hemoglobin), lipid control (decreased cholesterol with improved atherogenic profile) 4. Improved body composition (weight loss, increased lean body mass and decreased fat mass). 5. Decreased inflammation (assessed by high-sensitivity C-reactive protein), endothelial dysfunction (assessed by flow-mediated dilatation), and oxidative stress (assessed by reduced glutathione). 6. Increased health-related quality of life. In preparation for this proposal, we performed a 24-week randomized controlled feasibility study comparing aerobic exercise plus optimal medical management to medical management alone in patients with type 2 diabetes, obesity (BMI > 30 kg/m2), and stage 2-4 CKD (eGFR 15-90 mL/min/1.73m2) with persistent proteinuria of > 200 mg/g. Subjects randomized to exercise underwent thrice weekly aerobic training for 6 followed by 18 weeks of supervised home exercise. Exercise training resulted in a significant improvement in exercise duration, resting systolic blood pressure, and proteinuria. We now propose a larger-scale randomized controlled trial to determine the effects of exercise on renal functions, cardiovascular fitness, inflammation, and oxidative stress in diabetic patients with CKD. This will be a 52-week randomized controlled study. Subjects randomized to exercise will undergo 12 weeks of structured exercise training followed by 40 weeks of supervised home exercise (total duration of study 1 year). The primary outcome variable will be a decrease in proteinuria (albuminuria and total proteinuria) at 12 and 52 weeks. Blood pressure (BP), glycated hemoglobin, lipid profile, C-reactive protein (CRP) levels, and body weight and composition will be secondary outcome variables. In addition we will examine indices of endothelial dysfunction (by flow-mediated dilatation) and oxidative stress (plasma and urine malondialdehyde). Moreover, since blood pressure is such an important determinant of renal outcomes, we will take advantage of the VA Telehealth program to monitor home BPs in all subjects. We will also perform Quality of Life (QoL) evaluations, as such data are important for this project in order to establish that exercise can produce a meaningful improvement in perception of health in this population, as well as the Index of Coexistent Diseases (ICED) to measure comorbidities to determine if comorbid conditions had any influence on the outcomes of the study. The Center for Epidemiologic Studies Depression Scale (CES-D) will also be used to determine the influence of depression (covariate) on study outcomes and adherence with the study objectives. This study will directly address the effects of a structured exercise program in a patient population at high risk for cardiovascular complications. We will specifically address the novel idea that exercise will not only improve cardiovascular fitness but will also ameliorate the renal complications resulting from diabetes.

描述（由申请人提供）： 摘要：肥胖糖尿病合并慢性肾脏病患者的结构化运动：一项随机对照试验。 患有 2 型糖尿病、肥胖症和慢性肾病 (CKD) 的患者通常缺乏身体活动，死亡率很高，可能会从锻炼计划中受益。然而，还没有随机对照试验来确定运动训练对该人群的益处。本研究旨在证实以下假设：通过运动训练增加患有 CKD 的肥胖糖尿病患者的能量消耗将带来以下益处： 1. 肾脏益处，包括减少蛋白尿和稳定肾小球滤过率 (GFR) 2. 心血管益处，包括降低血压、降低心率和提高运动耐量。 3. 改善血糖控制（降低糖化血红蛋白）、血脂控制（降低胆固醇并改善动脉粥样硬化） 4. 改善身体成分（体重减轻、瘦体重增加和脂肪量减少）。 5.减少炎症（通过高敏C反应蛋白评估）、内皮功能障碍（通过血流介导的扩张评估）和氧化应激（通过还原型谷胱甘肽评估）。 6. 提高与健康相关的生活质量。 为了准备该提案，我们进行了一项为期 24 周的随机对照可行性研究，对 2 型糖尿病、肥胖症（BMI > 30 kg/m2）和 2-4 期 CKD 患者进行有氧运动加最佳医疗管理与单独医疗管理的比较(eGFR 15-90 mL/min/1.73m2)，持续蛋白尿> 200 mg/g。随机进行运动的受试者每周接受三次有氧训练，共 6 人，然后进行 18 周的监督家庭运动。运动训练显着改善了运动持续时间、静息收缩压和蛋白尿。 我们现在提出一项更大规模的随机对照试验，以确定运动对患有 CKD 的糖尿病患者的肾功能、心血管健康、炎症和氧化应激的影响。这将是一项为期 52 周的随机对照研究。随机进行运动的受试者将接受 12 周的结构化运动训练，然后是 40 周的监督家庭运动（研究总持续时间为 1 年）。主要结果变量是第 12 周和第 52 周时蛋白尿（白蛋白尿和总蛋白尿）的减少。血压 (BP)、糖化血红蛋白、血脂、C 反应蛋白 (CRP) 水平以及体重和成分将是次要结果变量。此外，我们将检查内皮功能障碍（通过血流介导的扩张）和氧化应激（血浆和尿液丙二醛）的指标。此外，由于血压是肾脏结果的重要决定因素，我们将利用 VA 远程医疗计划来监测所有受试者的家庭血压。我们还将进行生活质量 (QoL) 评估，因为此类数据对于该项目非常重要，以便确定运动可以显着改善该人群的健康认知以及共存疾病指数 (ICED)测量合并症以确定合并症是否对研究结果有影响。流行病学研究中心抑郁量表 (CES-D) 还将用于确定抑郁（协变量）对研究结果和遵守研究目标的影响。 这项研究将直接探讨结构化锻炼计划对心血管并发症高危患者群体的影响。我们将特别讨论这样一个新观点：运动不仅可以改善心血管健康，还可以改善糖尿病引起的肾脏并发症。