Human Metabolism of Ornithine Phenylacetate: A Study in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- metabolism of ornithine phenylacetate to glutamate and glutamine
研究概览
简要总结
Intravenous infusion of stable tracers of ornithine, glutamine, glutamate, and glycine will be performed, and collect blood samples, urine samples, and muscle biopsies to evaluate the effect of a continuous oral intake of phenylacetate salt of ornithine (OP) on its metabolic fate.
详细描述
The study involves 1 screening visit of approximately 1 hour and 4 study days of approximately 10 hours. The subject will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening day, body weight and height will be measured and Dual-energy X-ray absorptiometry (DXA) will be performed to measure body composition. After 4 hours subjects received a continuous intravenous infusion with OP in a dosage of 1 g /h. Next to the stable tracers provided to determine OP metabolism, stable tracers of phenylalanine (PHE) and tyrosine (TYR) may be provided to determine the effect of OP on protein metabolism at plasma and muscle tissue level. This required 2 muscle biopsies and on 2 study days 1 set of stable tracer pulses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects:
- •Healthy male & female according to the investigator's or appointed staff's judgment
- •Age 40-70 years (to be comparable with patients with liver cirrhosis: average 54.1 +/- 9.4 years)
排除标准
- •Metabolic diseases including diabetes and hepatic or renal disorders
- •Presence of acute illness or metabolically unstable chronic illness
- •Failure to give informed consent
- •(Possible) pregnancy
- •Any other condition according to the PI or nurse that would interfere with the study or safety of the patient or influence the results
- •Unwilling to stop taking nutritional protein supplements within 5 days before test day
- •History of hypo- or hyper-coagulation disorders, including use of a Coumadin derivative, history of deep venous thrombosis (DVT), or pulmonary embolism (PE) at any point in lifetime
- •Currently taking anti-thrombotics (i.e. medical indication) and cannot stop for 3-7 days prior to test days
- •Allergy to local anesthetic
研究组 & 干预措施
phenylacetate salt of ornithine
There are 4 study days of approximately 10 hours. Amino acid tracers (e.g., OP, PHE, TYR) will be provided via IV. The dosage of OP provided in this study 6 g in a period of 6 hours. 2 muscle biopsies will be completed on 2 of the study days.
干预措施: phenylacetate salt of ornithine (Other)
结局指标
主要结局
metabolism of ornithine phenylacetate to glutamate and glutamine
时间窗: 4 study days that are 8 hours each
The incorporation of the N atoms of ORN into glutamate, and the quantitative contribution of both pathways will be traced, and when the enrichment of ORN and GLU is measured in muscle tissue, give an estimation of the importance of muscle OAT for this incorporation.
次要结局
未报告次要终点
研究者
Marielle PKJ Engelen, PhD
Associate Professor
Texas A&M University