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：肥胖糖尿病患者患有慢性肾脏疾病的结构化运动：一项随机对照试验。 2型糖尿病，肥胖症和慢性肾脏疾病（CKD）的患者通常在身体上不活跃，死亡率很高，并且可能受益于运动计划。但是，尚无随机对照试验来确定该人群中运动训练的好处。这项研究旨在证实以下假设：CKD肥胖糖尿病患者的运动训练增加能量消耗将带来以下益处：1。肾脏益处，包括蛋白尿降低和肾小球过滤率的稳定（GFR）2。心血管效益2。心血管益处，包括降低血液压力，降低血液压力，心脏耐受性，运动耐受性，并增加了运动耐受性。 3。改善的葡萄糖对照（下糖化血红蛋白），脂质对照（胆固醇降低，改善了动脉粥样硬化的特征）4。改善了身体成分（体重减轻，瘦体重增加，体重增加和脂肪质量降低）。 5。炎症减少（通过高敏C反应蛋白评估），内皮功能障碍（通过流介导的扩张评估）和氧化应激（通过减少谷胱甘肽评估）。 6。与健康相关的生活质量提高。 为了准备这项提议，我们进行了一项24周的随机控制可行性研究，将有氧运动以及仅在2型糖尿病患者，肥胖症（BMI> 30 kg/m2）和2-4阶段CKD（EGFR 15-90 ML/MIN/MIN/MIN/1.73M2）的患者中，将有氧运动以及最佳医疗管理与医疗管理进行了比较。随机运动的受试者接受了三次的每周有氧训练，进行了6次接受监督的家庭运动。运动训练可显着改善运动持续时间，静息收缩压和蛋白尿。 现在，我们提出了一项大规模的随机对照试验，以确定运动对CKD糖尿病患者的肾功能，心血管适应性，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，然后进行40周的监督家庭运动（总学习期限为1年）。主要结局变量将是12和52周时蛋白尿（蛋白尿和总蛋白尿）的降低。血压（BP），糖化血红蛋白，脂质谱，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，因此我们将利用VA远程医疗计划来监视所有受试者的家庭BP。我们还将执行生活质量（QOL）评估，因为这样的数据对该项目很重要，以确定锻炼可以在该人群中对健康的感知产生有意义的改善，以及共有疾病（ICE）的指数（ICED），以测量合并症以确定合并症是否对研究结果有任何影响。流行病学研究中心抑郁量表（CES-D）也将用于确定抑郁症（协变量）对研究结果和遵守研究目标的影响。 这项研究将直接解决结构化运动计划对心血管并发症高风险的患者人群的影响。我们将特别解决这样一种新颖的想法，即运动不仅会改善心血管健康，而且还可以改善糖尿病引起的肾脏并发症。