GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 主要终点
- Blood concentration of galactose
研究概览
简要总结
The primary objective is to determine the galactose single point (GSP) cutoff values to discriminate subjects with different hepatic function. The secondary objective is to analyze the correlations between GSP and other hepatic function assessment methods among this trial subjects.
详细描述
Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease, including the potential for progression to nonalcoholic steatohepatitis (NASH), followed by fibrosis and ultimately cirrhosis. The gold standard to evaluate fibrosis in patients with NAFLD is liver biopsy. The investigators aimed to evaluate the clinical utility of using the galactose single point (GSP) test which recommended by the US FDA to quantitatively measure liver function in patients with NAFLD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must fulfill all of the following criteria to be eligible for the study:
- •Male or female with age between 20-
- •Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.
排除标准
- •Any of the following criteria will disqualify the subject from participation:
- •History of serious allergic reaction to galactose and have galactosemia.
- •History of receiving total gastrectomy, subtotal gastrectomy, celiac disease, or small intestinal resection.
- •History of diabetes mellitus.
- •Subjects are children or handicapped people.
- •Subjects with any other reasons considered by the investigator not in the condition to enter into the trial.
结局指标
主要结局
Blood concentration of galactose
时间窗: Sixty minutes
To determine the GSP cutoff values based on data obtained from this trial to discriminate subjects with different hepatic function
次要结局
未报告次要终点
研究者
Tung Yuan Shih
Research Assistant
National Defense Medical Center, Taiwan