Preventive Potential of Bilirubin

University of Vienna120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Mild Hyperbilirubinaemia

Interventions

No interventionOTHER

No intervention. case - control design.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The investigators will consider Lipid parameter

Compare plasma parameter of lipid metabolism (Cholesterol, LDL, HDL, Triglycerides, ..) between Gilbert´s Syndrome subjects and controls.

Time frame: Baseline

Secondary Outcomes

The investigators will consider plasma parameter of glucose metabolism

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.

Time frame: Baseline

The investigators will consider AMPK metabolic pathway

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.

Time frame: Baseline

The investigators will consider body composition

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.

Time frame: Baseline

The investigators will consider heme catabolic pathway

Compare parameter of the heme catabolic pathway (expression of heme oxygenase (RQ), expression of Biliverdinreductase (RQ)) between Gilbert´s Syndrome subjects and controls.

Time frame: Baseline

The investigators will consider the metabolomic response

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.

Time frame: Baseline

Data from ClinicalTrials.gov

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