Hepatic Mitochondrial Metabolism in Fatty Liver Disease in Humans
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in arterialized plasma b-OHB to AcAc ratio
研究概览
简要总结
The goal of this clinical trial is to investigate in healthy volunteers the mechanisms by which ethanol and lipids, the two key risk factors of steatotic liver disease (SLD), affect liver mitochondrial metabolism.
The main question it aims to answer is:
• Does acute administration of ethanol and lipids increase hepatic mitochondrial reductive stress as determined by orally ingested stable isotope tracer 13C-alpha-ketoisocaproate and by plasma beta-hydroxybutyrate to acetoacetate ratio (b-OHB/AcAc) in humans?
详细描述
In this study we investigate the effects of ethanol and lipids on hepatic mitochondrial metabolism in healthy volunteers.
At first visit, an informed consent will be obtained, followed by assessment of inclusion/exclusion criteria. Participants fulfilling the criteria will be enrolled in the study. Body composition will be determined with bioelectrical impedance.
At second visit hepatic lipid content will be measured with magnetic resonance spectroscopy.
Participants will be given in random order on three separate visits (3-5):
- Intravenous infusion of ethanol and normal saline (breath alcohol content target and upper limit corresponding to 0.6 per mil in blood)
- Intravenous infusions of lipid emulsion, heparin and normal saline
- Intravenous infusion of normal saline
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in arterialized plasma b-OHB to AcAc ratio
时间窗: From baseline to the end of treatment at 240 minutes
Arterialized plasma b-OHB and AcAc concentrations
Breath 13CO2 enrichment after ingesting 13C-alpha-ketoisocaproate
时间窗: From baseline to the end of treatment at 330 minutes.
Measured as area under the curve
次要结局
未报告次要终点
研究者
Panu Luukkonen
MD, PhD
Helsinki University Central Hospital