MRT-based Pilot Study to Evaluate Peroral Supplemental Nutrition for Prevention of Cachexia in End-stage Renal Disease With and Without HIV Comorbidity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Cross sectional area of triceps m. in mid-humerus position (MRT)
研究概览
简要总结
End-stage renal disease is often accompanied by malnutrition due to less appetite, metabolic changes or both. Human immunodeficiency virus-infection may exacerbate the state of malnutrition. In a pilot study, we recruit both HIV invected and non-infected patients on hemodialysis. Non-HIV patients will be randomized to peroral supplemental nutrition or no peroral supplemental nutrition. All HIV patients will receive peroral supplemental nutrition. The nutritional state will be determined in magnet resonance tomography at the start and at the end of the study (muscle diameter of triceps m.) and with laboratory parameters (plasma albumin and others). The hypothesis is that supplemental peroral nutrition (a total 250 kcal per day) will stop loss of muscle mass in end-stage renal disease patients (compared to their counterparts without supplemental peroral nutrition) as well as in the high risk group of HIV patients. This pilot study may lead to larger randomized clinical trials and, may affect dietary recommendations.
详细描述
In end-stage renal disease (ESRD), cachexia is a common finding. Metabolic changes, malnutrition, or both appear to be the underlying problems. In fact, lean body mass per body weight better predicts prognosis than creatinin based models (NDT, 2004.19:1182). In addition, comorbidity such as HIV infection may exacerbate cachexia found in ESRD. Whether or not daily supplemental, high-caloric nutrition in ESRD corrects a catabolic state in ESRD is unclear.
Hypothesis to be tested:
Daily supplemental high-caloric nutrition beneficially affects cytokine stimulation (TNF alpha, IL 1beta, IL 6, CrP) and nutritional state (cross sectional area of triceps m. in mid-humerus position (MRT), plasma albumin) in in HIV-positive hemodialysis patients and in chronic hemodialysis patients compared to chronic hemodialysis patients without supplemental nutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients on hemodialysis for more than 1 year,
- •Group 1: HIV infection
排除标准
- •patients on hemodialysis for less than 1 year,
- •Group 2 and 3: HIV infection
- •no pre-/post dialysis weight differences of > 3 kg after long HD free interval over last 10 HD sessions.
- •no current high-caloric nutrition supplements or planned high-caloric supplements for clinical reasons.
- •pregnancy
- •for women: no use of oral contraceptives or other at least equally effective contraception in women with childbearing potential
- •known neoplastic disease other than skin tumors (except melanoma)
- •mental disease or retardation with impaired judgement power
结局指标
主要结局
Cross sectional area of triceps m. in mid-humerus position (MRT)
时间窗: 6 months
次要结局
- plasma albumin < 3.6 mg/dl(6 months)