此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Body Fat Mass Association With Clinical Metabolic Profiles, Markers of Inflammation and Adipocytokines

2017年2月17日 更新者:Tungs' Taichung Metroharbour Hospital

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.

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.

研究概览

地位

完全的

详细说明

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.

Anthropometric parameters The following data will collected bimonthly : height (m)), dry weight (kg) measured with a calibrated scale and body mass index(BMI,kg/m2). Abdominal obesity is defined as a waist circumference of >80 cm in women and >90 cm in men.

Biochemical assays and other measurements Fasting blood samples (4 ml each time) were taken just before starting a dialysis session.The vacutainers were kept cold and placed immediately on ice, then they were centrifuged at 4 degree centigrade and the serum was stored at -80 degree centigrade until the analysis. The measurements of serum creatinine, cholesterol, total proteins, albumin, prealbumin and carbon dioxide(CO2) were analysed using standard methods. Urea reduction ratio and single-pool dialysis efficiency calculator(Kt/V) were used to represent the administered dialysis treatment dose. To decrease intraindividual variation, 3-month averaged values for laboratory measures and urea reduction ratio during the study calendar quarter were calculated and used in this study. High sensitivity C- reactive proteins(CRP) was obtained by the immuno-turbidimetric method. Serum 25(OH)D3 was measured by enzymeimmunoassay and the levels of intact parathyroid hormone( i-PTH) were assessed using immunoradiometric assay. Plasma insulin levels were measured using a radioimmunoassay method. Interleukin-6(IL-6) and tumor necrosis factor-alpha (TNF-α) concentrations were measured in duplicate by enzyme-linked immunosorbent assay(ELISA). Insulin resistance was assessed using the following validated formula: homeostasis model assessment of insulin resistance (HOMA-IR)=(fasting glucose [mmol/1] × fasting insulin [μU/ml])/22.5. Because of confounding introduced by exogenous insulin administration to HOMA-IR results, HOMA-IR was only measured in patients who were not treated with insulin . All the above measurements will be done at baseline, and the end of each years (4 times for the whole study)

研究类型

观察性的

注册 (实际的)

65

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 100年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

hemodialysis (HD) patients

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with malignant disease, acute infectious disease, acute inflammatory disease (such as collagen disease), and advanced liver disease are excluded.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Occurence of CVD events
大体时间: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).

3 years

次要结果测量

结果测量
措施说明
大体时间
Correlates of metabolic syndrome
大体时间:3 years
The measurements of cholesterol(mg/dl),albumin(mg/dl) ,plasma insulin levels(mU/L) were measured using a radioimmunoassay method. Insulin resistance was assessed using the following validated formula: homeostasis model assessment of insulin resistance (HOMA-IR)=(fasting glucose [mmol/1] × fasting insulin [μU/ml])/22.5
3 years
Presence of inflammation
大体时间:3 years
Various biomarkers such as CRP, IL-6, TNF-a
3 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年3月1日

初级完成 (实际的)

2016年12月1日

研究完成 (实际的)

2016年12月1日

研究注册日期

首次提交

2016年5月26日

首先提交符合 QC 标准的

2016年6月9日

首次发布 (估计)

2016年6月15日

研究记录更新

最后更新发布 (实际的)

2017年2月20日

上次提交的符合 QC 标准的更新

2017年2月17日

最后验证

2017年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 102047

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅