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临床试验/NCT02799719
NCT02799719已完成不适用

Body Fat Mass as Predictors of Survival in Hemodialysis Patients and Its Association With Clinical Metabolic Profiles, Markers of Inflammation and Adipocytokines in Chronic Hemodialysis Patients: a Prospective Study.

Tungs' Taichung Metroharbour Hospital0 个研究点目标入组 65 人开始时间: 2014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
65
主要终点
Occurence of CVD events

研究概览

简要总结

Overweight and obesity have become an increasing problem in patients on hemodialysis. However, in virtually all observational studies in chronic kidney disease(CKD) and dialysis patients , using body mass index(BMI) as metric fat mass is associated inversely with death rate. Nevertheless, it is questionable that obesity can be considered an unequivocal protective factor in chronic diseases as increase body fat mass appears to be a potential cause of the chronic inflammation frequently present in these patients. The consequences of this inflammation are impaired nutritional status, accelerated atherosclerosis, and increased mortality. In the present study, by using dual-energy X-ray absorptiometry (DEXA) and bioimpedance spectroscopy (BIS) to evaluated the contributions of fat mass to outcomes in an observational cohort of hemodialysis patients. Besides, we aim to assess the relationship between body fat composition, clinical metabolic risk profiles, measures of adiposity, such as waist circumference (WC), visceral adiposity index, waist-to-hip ratio (WHR), and waist-to-height ratio (WHtR), markers of inflammation and adipocytokines in these maintenance hemodialysis patients.

详细描述

Patient Selection

Clinically stable stage 5 chronic kidney disease patients (400 patients) attending the Tungs Taichung Metroharbour will be enrolled in this study. These patients will be given written information and are invited to participate in the study. Written informed consent will be obtained from each patient enrolled. Our hospital dialysis center undergoes multi-frequency bioelectrical impedance analysis( BIA) scanning on a bimonthly basis as part of their ongoing clinical care. Multi-frequency BIA is performed on patients attending the center as part of their routine dry weight assessment. Among these patients, eighty ambulatory adults attending for thrice-weekly outpatient hemodialysis treatments concomitantly had similar dual-energy X-ray absorptiometry (DEXA) scan and postdialysis multi-frequency BIA assessments for review. Patients with implantable defibrillators, those with cardiac pacemakers, and amputees are excluded from the study. This study will be conducted prospectively for 3 years.

Methods Body Composition Assessment Measurements with dual-energy X-ray absorptiometry (DEXA)

DEXA was performed with patients in the supine position. The radiation exposure is estimated to be one tenth of that for standard chest radiography. DEXA is scheduled postdialysis. Whole-body composition, including total and segmental lean, total body fat mass, and bone mineral content, will be calculated using the compatible software. For patients with multiple multifrequency BIA estimations, the study performed will be arranged temporally to the DEXA scan for more relevant comparison.

Measurement of Bioimpedance In all patients BIS will be carried out bimonthly using the Body Composition Monitor (Fresenius Medical Care Deutschland Gesellschaft mit beschrankter Haftung (GmbH), Germany), which takes measurements at 50 frequencies in a range of 5 to 1000 kilohertz(KHz). The measurement was performed approximately 30 minutes after the midweek hemodialysis session, with four conventional electrodes being placed in the patient, who was lying in the supine position: two in the hand and two in the foot contralateral to the vascular access. Regarding the quality of measurements, all exceeded 95%. The manufacturer of the Body Composition Monitor (Fresenius Medical Care) indicated that 30 minutes after the hemodialysis session, the balance between intra-and extracellular fluid was restored and no significant differences in relation to pre-dialysis values were observed. Parameters obtain directly through BIS that are used in this study are free fat mass, lean body mass, intracellular water (ICW) and extracellular water( ECW). Protein-energy wasting (PEW), represented by the intracellular water/dry body weight (ICW/BW) ratio, and overhydration, represented by the extracellular water/dry body weight(ECW/BW) ratio will be analysed.

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
否

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 (such as collagen disease), and advanced liver disease are excluded.

结局指标

主要结局

Occurence of CVD events

时间窗: 3 years

A DEXA scan is used to measure total and segmental lean(kg), total body fat mass(kg), and bone mineral content(kg). A BIS is used to measurefree fat mass(Kg), lean body mass(Kg),ICW(L) and ECW(L).

次要结局

  • Presence of inflammation(3 years)
  • Correlates of metabolic syndrome(3 years)

研究者

发起方
Tungs' Taichung Metroharbour Hospital
申办方类型
Other
责任方
Sponsor

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