Mapping of Metabolic Liver Functions in Patients With Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Metabolic Liver Function assessed by ABT
研究概览
简要总结
Background: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the western world and an important cause of morbidity and mortality including risk of cardiovascular disease. A ruling dogma is that a fatty liver is well-functioning. Recent studies imply the contrary but quantitative measurements of metabolic liver function have not been systematically investigated in NAFLD.
Objectives: To study and quantify specific metabolic liver functions in varying degrees of NAFLD. Furthermore to map the coagulation system of patients with NAFLD.
Methods: A human clinical study. Metabolic liver functions are studied by a series of functional tests (Galactose elimination capacity (GEC), Aminopyrine breath test (ABT), Indocyanine green plasma disappearance rate (ICG-PDR), Functional hepatic nitrogen clearance (FHNC)). Regional liver function evaluated by 2-[18F]fluoro-2-deoxy-D-galactose (FDGal) PET/CT is compared to fat infiltration assessed by Magnetic resonance imaging (MRI). Primary and secondary hemostasis, natural anti-coagulants and fibrinolysis are evaluated.
Perspectives: To challenge the dogma, that hepatic metabolic function is not affected in NAFLD, improving the understanding of the relationship between the clinical degree of NAFLD, histology, metabolic functions, and imaging. Furthermore to disclose a proposed procoagulant imbalance in NAFLD.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Hepatic steatosis found on ultrasound
- •Clinical indication for liver biopsy (typically persistently elevated alanine transaminase (ALT) levels)
排除标准
- •Other liver pathology
- •Alcohol consumption > 20g/day
- •Chronic inflammatory disease, current infection or cancer
- •Diabetes mellitus type I, II or HbA1c ≥ 48 mmol/mol (6.5 %)
- •Prednisolone treatment within last 8 weeks
- •Pregnancy within last 12 months
- •Contraindication for MRI
结局指标
主要结局
Metabolic Liver Function assessed by ABT
时间窗: Baseline
Regional metabolic liver function evaluated by FDGal PET/CT
时间窗: Baseline
100 megabecquerel FDGal is injected intravenously in the beginning of a 20 min PET recording and 3D images of regional metabolic liver function expressed in terms of hepatic metabolic clearance of FDGal is created.
Metabolic Liver Function assessed by GEC
时间窗: Baseline
Metabolic Liver Function assessed by ICG-PDR
时间窗: Baseline
Regional fat infiltration assessed by MRI
时间窗: Baseline
Metabolic Liver Function assessed by FHNC
时间窗: Baseline
次要结局
- Primary hemostasis(Baseline)
- Secondary hemostasis(Baseline)
- Fibrinolysis(Baseline)
- Natural anti-coagulants(Baseline)