Clinical trial NCT04792996: Preventive Potential of Bilirubin
Official title: Investigating the Preventive Potential of Bilirubin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Hyperbilirubinaemia
Lead sponsor: University of Vienna
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
First posted: 2021-03-11
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120 participants, 60 participants with mild hyperbilirubinaemia, 60 subjects without mild hyperbilirubinaemia, age and gender matching.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The investigators will consider Lipid parameter
timeFrame: Baseline
Secondary outcomes:
measure: The investigators will consider plasma parameter of glucose metabolism
timeFrame: Baseline
measure: The investigators will consider AMPK metabolic pathway
timeFrame: Baseline
measure: The investigators will consider body composition
timeFrame: Baseline
measure: The investigators will consider heme catabolic pathway
timeFrame: Baseline
measure: The investigators will consider the metabolomic response
timeFrame: Baseline
measure: The investigators will consider the composition of gut-microbiota
timeFrame: Baseline
measure: The investigators will consider oxidative stress marker
timeFrame: Baseline
measure: The investigators will consider anabolic and catabolic hormones
timeFrame: Baseline
measure: The investigators will consider telomere length
timeFrame: Baseline
measure: The investigators will consider RNA and DNA gene expression
timeFrame: Baseline
measure: The investigators will consider the metabolomic response after a standard breakfast
timeFrame: Five blood samplings over 180 minutes.
Other outcomes:
Locations:
Study officials:
References: