Mild Hyperbilirubinaemia
Conditions
Brief summary
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.
Interventions
OTHERNo intervention
No intervention. case - control design.
Sponsors
Medical University of Vienna
University of Vienna
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Inclusion criteria
In general * 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
Exclusion criteria
In general * Age \< 20 or \> 80 years * Cardiovascular diseases * Liver diseases (including Hep B and C) * Cholelithiasis * Hemolysis * Renal diseases * Active tumors * Diabetes mellitus * Smoking * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The investigators will consider Lipid parameter | Baseline | Compare plasma parameter of lipid metabolism (Cholesterol, LDL, HDL, Triglycerides, ..) between Gilbert´s Syndrome subjects and controls. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The investigators will consider AMPK metabolic pathway | Baseline | Compare parameter of the AMPK metabolic pathway (phosphorylated AMPK (rfU), phosphorylated Ppar-alpha (rfU), phosphorylated Ppar-gamma (rfU)) between Gilbert´s Syndrome subjects and controls. |
| The investigators will consider body composition | Baseline | Compare parameter of the body composition (BMI (kg/m2), fat mass (%), waist circumference (cm), hip circumference (cm), abdominal circumference (cm)) between Gilbert´s Syndrome subjects and controls. |
| The investigators will consider heme catabolic pathway | Baseline | Compare parameter of the heme catabolic pathway (expression of heme oxygenase (RQ), expression of Biliverdinreductase (RQ)) between Gilbert´s Syndrome subjects and controls. |
| The investigators will consider the metabolomic response | Baseline | Compare the metabolomic pattern (ie all metabolites; analyzed using both nuclear magnetic resonance (NMR) and mass spectrometry (MS) techniques) between Gilbert´s Syndrome subjects and controls. |
| The investigators will consider the composition of gut-microbiota | Baseline | Compare the composition of the gut microbiota (Gene sequencing of the 16S rRNA on the stool samples are performed to identify the microbes down to genus level as well as the microbial diversity and relative abundance) between Gilbert´s Syndrome subjects and controls. |
| The investigators will consider plasma parameter of glucose metabolism | Baseline | Compare plasma parameter of glucose metabolism (plasma glucose (mg/dl), plasma insulin (µU/ml), C-peptide (ng/ml)) between Gilbert´s Syndrome subjects and controls. |
| The investigators will consider anabolic and catabolic hormones | Baseline | Compare plasma concentrations of hormones (Glucagon (pg/ml), T3 (pg/ml), TSH(µM/ml),) between Gilbert´s Syndrome subjects and controls. |
| The investigators will consider telomere length | Baseline | Compare telomere length between Gilbert´s Syndrome subjects and controls. |
| The investigators will consider RNA and DNA gene expression | Baseline | Compare RNA and DNA gene expression between Gilbert´s Syndrome subjects and controls. |
| The investigators will consider the metabolomic response after a standard breakfast | Five blood samplings over 180 minutes. | Compare the metabolomic pattern after a standard breakfast (ie all metabolites; analyzed using both nuclear magnetic resonance (NMR) and mass spectrometry (MS) techniques) between Gilbert´s Syndrome subjects and controls. |
| The investigators will consider oxidative stress marker | Baseline | Compare plasma concentrations of oxidative stress marker such as malondialdehyde or GSH/GSSG between Gilbert´s Syndrome subjects and controls. |
Outcome results
None listed