Serum YKL-40 Levels is Associated With Nutritional and Oxidative Status of Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Analysis of biomarkers of YKL40
研究概览
简要总结
Background
YKL-40 is a glycoprotein that had been reported to be associated with inflammation atherosclerosis and endothelial dysfunction. The objective is to explore the association of serum YKL-40 levels with nutrition status, inflammation, and body composition in a cohort of hemodialysis patients
Methods
We plan to recruit 400 prevalent HD patients. Their baseline serum YKL-40 levels, body anthropometry, the profile of insulin resistance, bioimpedance spectroscopy parameters, and nutritional indices will be measured.
详细描述
Study Design and Patients
Patients This is a prospective observational study. The patients will be recruited from HD patients at dialysis units of Tungs Taichung Metroharbour Hospital, which is an outpatient facility. The study inclusion criteria of participants are those maintain on HD therapy for at least 3 months prior to enrollment and being in stable condition without co-morbidities such as heart failure, infection, cirrhosis, respiratory disease, nephrotic syndrome, malignancy, chronic liver disease, or severe inflammation. None of the patients are receiving surgical operations or hospitalized in recent 3 months. In this study, written informed consent will be obtained from all participants. The study protocol will be send to the institutional review board of Tungs Taichung Metroharbour Hospital for approval. The study will be registered to the ClinicalTrial. Gov. Registry and will fully adhered to the guidelines of the Declaration of Helsinki
Methodology
Laboratory measurements Blood samples will be collected before dialysis session. Serum biochemistry such as albumin, urea nitrogen, uric acid, creatinine, total cholesterol, triacylglycerol levels, total ion binding capacity (TIBC), 25-hydroxyvitamin D, hemoglobin, and white blood count are measured employing standard laboratory techniques with the use of an automatic analyzer. Serum prealbumin and high-sensitivity C-reactive protein (hs-CRP) are quantified by nephelometry. YKL-40 and interleukin-6 (IL-6) were quantified by a double-sided sandwich-type enzyme-linked immunosorbent assay (ELISA) kit (R&D Systems ; Minneapolis, MN, USA).
Fasting glucose levels were measured, after overnight fast and classified according to the American Diabetes Association (ADA) standards [29]. In addition, the serum insulin level, and hemoglobin A1c level are measured. The assessment of insulin resistance is done using the HOMA-IR index [30]: HOMA - IR = fasting glucose (in mmol/l) × fasting insulin (in µU/ml) / 22.5 Serum insulin, vaspin, and adiponectin level is measured by a commercially available ELISA kit following the manufacturer's instructions. Markers of oxidative stress such as total antioxidant capacity [TAC]), serum advanced oxidation protein products (AOPP) and serum CML (a component of AGEs) will also be measured.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes aged 20 years or over
- •Received stable hemodialysis at least 3 months.
- •Written informed consent.
排除标准
- •heart failure
- •infection
- •cirrhosis
- •respiratory disease
- •nephrotic syndrome
- •malignancy
- •chronic liver disease
- •severe inflammation
- •None of the patients are receiving surgical operations or hospitalized in recent 3 months.
结局指标
主要结局
Analysis of biomarkers of YKL40
时间窗: 1 years
YKL40 is also reportedly useful as an inflammation marker in HD patients
Evaluation of nutritional status and body composition
时间窗: 1 years
Malnutrition, with a prevalence between 40% and 75% in maintenance hemodialysis patients is the most important risk factor for morbidity, the quality of life, all-cause mortality and cardiovascular mortality.
次要结局
- insulin(1 years)
- adiponectin(1 years)
- vaspin(1 years)
- total antioxidant capacity(1 years)
- AOPP(1 years)
- Nε-Carboxymethyllysine (CML)(1 years)
- Analysis of biomarkers of IL-6(1 years)