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临床试验/NCT04309201
NCT04309201已完成不适用

Relationship With Muscle Wasting and Insulin Resistance in a Group of Non-diabetic Hemodialysis Patients.

Tungs' Taichung Metroharbour Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Analysis of biomarkers of β-aminoisobutyric Acid( L-BAIBA) levels

研究概览

简要总结

Insulin resistance (IR) is an early metabolic alteration in chronic kidney disease (CKD) patients, becoming almost universal in those who reach the end stage of kidney failure. The skeletal muscle represents the primary site of IR in CKD, and alterations at sites beyond the insulin receptor are recognized as the main defect underlying IR in this condition. The etiology of IR in CKD is multifactorial in nature and may be secondary to disturbances that are prominent in renal diseases, including physical inactivity, chronic inflammation, oxidative stress, vitamin D deficiency, metabolic acidosis, anemia, adipokine derangement, and altered gut microbiome.

IR has been solidly associated with intermediate mechanisms leading to cardiovascular (CV) disease in CKD including left ventricular hypertrophy, vascular dysfunction, and atherosclerosis. Recent studies have identified a muscle factor β-aminoisobutyric acid (BAIBA), which is produced by skeletal muscle during physical activity. BAIBA have been found to link with sedentary life style, abdominal obesity, and impairments in carbohydrate and lipid metabolism. A few studies have shown that BAIBA can protect from diet-induced obesity in animal models. It induces transition of white adipose tissue to a "beige" phenotype, which induces fatty acids oxidation and increases insulin sensitivity. While the exact mechanisms of BAIBA-induced metabolic effects are still not well understood, the aim of this study is want to study its relationship with muscle wasting and insulin resistance in a group of non-diabetic hemodialysis patients.

详细描述

Study Design and Population

Patients and Methods

This study is an observational, cross-sectional and prospective cohort study. One hundred and fifty patients on non-diabetic hemodialysed patients will be included for the cross-sectional survey; Twenty healthy subjects will be elected as the controls. Prevalent adult HD patients with dialysis vintages over 3 months will be recruited. Patients are maintained on regular HD prescription, three times a week, for four-hour sessions. Subjects with significant comorbid conditions such as cancer, heart failure, or severe liver disease and chronic infection such diabetic foot will be excluded. This study is conducted according to the guidelines laid down in the Declaration of Helsinki, and all procedures were reviewed as well as approved by the Regional Hospital Ethics Committee. All subjects should give their written informed consent to participate in the study. Subjects' demographic and clinical characteristics, including age, gender, weight, height, body mass index (BMI), dialysis vintage, and Kt/V will be recorded, and comorbidities and current therapies will be collected.

Anthropometric and biochemical assessments

Systolic and diastolic blood pressures are taken with the subjects in the supine position. A measurement of height and weight was performed on all subjects. Waist circumference was measured at the midpoint between the lower border of the rib cage and the iliac bone. The concentration of plasma insulin was assayed by radioimmunoassay. Fasting plasma glucose was measured using the glucose oxidase method. HbA1c was measured by affinity chromatography. Total cholesterol, triglyceride, and HDL cholesterol levels were measured enzymatically using an autoanalyzer (Hitachi 747; Hitachi, Tokyo, Japan). Serum insulin concentrations are determined by IRMA. Adiponectin and leptin concentrations are measured using a commercially available ELISA kit.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Received stable hemodialysis at least 3 months

排除标准

  • •heart failure
  • •severe liver disease
  • •chronic infection such diabetic foot

结局指标

主要结局

Analysis of biomarkers of β-aminoisobutyric Acid( L-BAIBA) levels

时间窗: 1 years

BAIBA can protect from diet-induced obesity in animal models. It induces transition of white adipose tissue to a "beige" phenotype, which induces fatty acids oxidation and increases insulin sensitivity.

次要结局

  • Presence of Sarcopenia(1 years)

研究者

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

研究点 (1)

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