Preventive Potential of Bilirubin (BILIHEALTH)

University of Vienna

Status: Completed

Conditions: Mild Hyperbilirubinaemia

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04792996

UNIVIE-BILIHEALTH

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Gilbert´s Syndrome

Description:

Subjects with mild hyperbilirubinaemia and a plasma level of unconjugated bilirubin of 17.1 µmol.

Treatment:

Other: No intervention

Control group

Description:

Healthy controls with lower plasma level of unconjugated bilirubin of 17.1 µmol, aen and gender matched.

Treatment:

Other: No intervention