Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Effect of glucose and glucose-insulin infusion on plasma IGF-I and IGFBP-1 during hemodialysis
研究概览
简要总结
The purpose of this study is to investigate whether the anabolic potentials of insulin may be used to reverse the catabolic effects of hemodialysis in non-diabetic patients with end-stage renal failure.
详细描述
Nutritional markers such as lean body mass and serum albumin are strong predictors of the mortality and morbidity in patients with end-stage renal failure (ESRF) on maintenance hemodialysis (HD). Maintenance HD is considered to contribute to the malnutrition of patients with ESRF, but the exact mechanism has remained unknown. However, we have recently shown that the bioactivity of insulin-like growth factor-I (IGF-I) is reduced by 50% during HD. Furthermore, we showed that the reduction in the bioactivity of IGF-I is directly linked to an up-regulation of IGF-binding protein-1 (IGFBP-1), the only acutely regulated IGFBP, which increased by 6-fold during HD. IGFBP-1 is produced in the liver, primarily under the control of insulin, which promptly inhibits the hepatic production of IGFBP-1. As plasma insulin remains fairly low during a maintenance HD, the increase in IGFBP-1 may be explained by the absence of insulin.
The finding that HD acutely down-regulates the bioactivity of IGF-I by an up-regulation of IGFBP-1 may not only explain the catabolic mechanisms of HD per se, it also opens for a new treatment strategy of ESRF patients undergoing maintenance HD. Thus, on the basis of our previous study we hypothesize that treatment of ERSF patients with high doses of insulin during maintenance HD may counter-act the HD-induced stimulation of IGFBP-1, making it possible to preserve the bioactivity of IGF-I, and thereby abolishing the catabolic impact of HD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years
- •stable patients on maintenance hemodialysis for > 3 months
- •well-functioning arteriovenous (AV) shunt with recirculation < 5%
- •informed consent
排除标准
- •diabetes mellitus
- •body mass index < 18.5 kg/m2 or > 30 kg/m2
- •malnutrition (subjective global assessment (SGA) score C)
- •malignancy
- •use of immunosuppressive drugs including glucocorticosteroids
- •severe infectious disease < 4 weeks
- •pregnancy
- •Exclusion Criteria during the study:
- •myocardial infarction or arrythmia with hemodynamic derangements
- •permanent thrombosis in the arteriovenous (AV) shunt
- •severe infectious disease
- •renal transplantation
研究组 & 干预措施
Glukose-infusion
Glucose-infusion during hemodialysis
干预措施: Glucose-infusion (Drug)
Glucose-insulin infusion
Glucose-insulin infusion during hemodialysis
干预措施: Glucose-insulin infusion (Drug)
结局指标
主要结局
Effect of glucose and glucose-insulin infusion on plasma IGF-I and IGFBP-1 during hemodialysis
时间窗: From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis
All patients are randomly assigned to a hemodialysis session with either i) no infusion, ii) a continuous iv infusion of glucose, and iii) a continuous iv infusion of glucose and shortacting insulin. Each dialysis session will be separated by 2 weeks of wash-out
次要结局
- Relationship between inflammatory markers and plasma concentrations of IGF-I and IGFBP-1 during hemodialysis(From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis)