Investigating the Preventive Potential of Bilirubin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- The investigators will consider Lipid parameter
研究概览
简要总结
The prevalence of mild hyperbilirubinemia, also known as Gilbert´s Syndrome, is usually defined using an unconjugated bilirubin (UCB) blood concentration above 17.1 µmol/l. The prevalence of GS is remarkably common, affecting 5-10% (depending on ethnicity and gender) of the adult population.
The aim of this project is to investigate whether there is a difference in health related marker between 60 subjects with Gilbert´s Syndrome (mild hyperbilirubinaemia) and 60 age and gender matched control subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- 否
入选标准
- •Signed declaration of consent
- •Age: 20-80 years
- •Liver enzymes (AST, ALT, GGT) < 1.5x over norm values
- •Non smoking
- •Moderate physical activity
- •Ability to communicate with the study team in the local language to understand the study procedure
- •Cases (GS):
- •Total blood bilirubin > 1.2 mg/dl
- •Unconjugated bilirubin > 1 mg/dl
- •Controls (non-GS):
- •Total blood bilirubin ≤ 1.2 mg/dl
- •Unconjugated bilirubin ≤ 1 mg/dl
排除标准
- •Age < 20 or > 80 years
- •Cardiovascular diseases
- •Liver diseases (including Hep B and C)
- •Cholelithiasis
- •Hemolysis
- •Renal diseases
- •Active tumors
- •Diabetes mellitus
- •Professional athletes
- •Subjects with organ transplants
- •Intake of antioxidants within the last 4 weeks
- •Intake of liver influencing medication within the last 5 weeks
- •Cases (GS):
- •Total blood bilirubin ≤ 1.2 mg/dl
- •Unconjugated bilirubin ≤ 1 mg/dl
- •Controls (non-GS):
- •Total blood bilirubin > 1.2 mg/dl
- •Unconjugated bilirubin > 1 mg/dl
结局指标
主要结局
The investigators will consider Lipid parameter
时间窗: Baseline
Compare plasma parameter of lipid metabolism (Cholesterol, LDL, HDL, Triglycerides, ..) between Gilbert´s Syndrome subjects and controls.
次要结局
- The investigators will consider AMPK metabolic pathway(Baseline)
- The investigators will consider the metabolomic response(Baseline)
- The investigators will consider heme catabolic pathway(Baseline)
- The investigators will consider the composition of gut-microbiota(Baseline)
- The investigators will consider oxidative stress marker(Baseline)
- The investigators will consider telomere length(Baseline)
- The investigators will consider the metabolomic response after a standard breakfast(Five blood samplings over 180 minutes.)
- The investigators will consider plasma parameter of glucose metabolism(Baseline)
- The investigators will consider body composition(Baseline)
- The investigators will consider anabolic and catabolic hormones(Baseline)
- The investigators will consider RNA and DNA gene expression(Baseline)
研究者
Wagner Karl-Heinz
Professor of Human Nutrition
University of Vienna