跳至主要内容
临床试验/NCT02718612
NCT02718612已完成不适用

Association Between Sarcopenia and Sarcopenic Obesity With Metabolic and Cardiovascular Risk Factors in Taiwanese Dialysis Patients

Tungs' Taichung Metroharbour Hospital0 个研究点目标入组 70 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
主要终点
Presence of sacropenia

研究概览

简要总结

Uraemic sarcopenia is complex, and progressive . As older persons are particularly susceptible to renal failure and this accelerates the physiological muscle wasting in this patient group. Hence sarcopenia is an important factor of functional impairment in elderly patients suffering from chronic kidney disease. On the other hand, overweight has become increasing common in dialysis patients, and is paradoxically reported to be associated with better survival. It remains unclear if adipose tissue in overweight in elderly dialysis patients is a source of proinflammatory mediators, which could contribute to protein-energy wasting (PEW), cardiovascular disease, and increased mortality. This study attempts to explore the prevalence of Sarcopenic Obesity (SO) in a cohort of hemodialysis patients with a more well defined criteria. In addition, this study aims to examine the association between sarcopenia and SO with metabolic and cardiovascular risk factors in these patients.

详细描述

Patients

The study is a cross-sectional analysis of all patients on hemodialysis patients treated at Tungs' Taichung Metroharbor hospital(500 patients). Patients ≥20 years of age and been on maintenance hemodialysis for at least 3 month before the study. The dialysis sessions were 3.5 to 4.5 h three times per week, with a blood flow greater than 300 mL/min, a dialysate flow of 600 mL/min, and a bicarbonate buffer.

Clinical assessments and data collection

The investigators collect baseline clinical data [such as age, sex, height, bodyweight, clinical etiology of Chronic Kidney Disease if possible, comorbidities, blood pressure, laboratory measures [such as serum creatinine, albumin, C-reactive protein (CRP), total cholesterol, complete blood counts, total carbon dioxide, anthropometric information and various potential indicators of PEW [such as body mass index, waist/hip ratio, mid-arm circumference (MAC), triceps skinfold thickness (TSF), mid-arm muscle circumference (MAMC), mid-arm muscle area (MAMA), SGA, BIA analyses, and hand grip Strength (HGS). For the laboratory tests, fasting blood samples are obtained from each patient and are performed in the Department of Clinical Pathology of the investigators hospital by means of routine methods. Interleukin-6 (IL-6) and tumour necrosis factor-α(TNF-α )levels are measured via immunometric enzyme immunoassay. Insulin is analyzed using human ELISA kits . Sensitivity is 2.88 pmol/L, and the upper limits of intra- and inter-assay coefficients of variation were 3.3 and 7.6, respectively. Homeostatic Model Assessment Insulin Resistance(HOMA-IR) was calculated as fasting insulin (U/l) × fasting glucose (mg/dl)/405, as described by Matthews et al.

All patients received echocardiograms studies performed within 3 months after enrollment, which were used to estimate Congestive Heart Failure (defined as an ejection fraction of <40%) or left ventricular hypertrophy (LVH, defined as left ventricle mass index 125 g/m2 in men and 100 g/m2 in women). Cardiovascular disease is defined as a previous history of Congestive Heart Failure, LVH, ischemic heart disease(including prior history of angina, myocardial infarction, coronary artery bypass grafting and percutaneous cardiac catheter intervention) or cerebrovascular disease (including prior history of transient ischemic attack and stroke).

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both sexes aged > 20 years-old.
  • Received stable hemodialysis at least 3 months.
  • Written informed consent.

排除标准

  • Patients with malignant disease, acute infectious disease, acute inflammatory disease,liver cirrhosis, and chronic use of any type of immunosuppressive medication are excluded.

结局指标

主要结局

Presence of sacropenia

时间窗: one year

Definition and diagnosis of sarcopenia from European European Working Group on Sarcopenia based on 1. Low muscle mass 2. Low muscle strength 3. Low physical performance

次要结局

未报告次要终点

研究者

发起方
Tungs' Taichung Metroharbour Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paik Seong Lim

MD

Tungs' Taichung Metroharbour Hospital

相似试验

Prevalence and Determinants of Sarcopenic Obesity in... | 临床试验