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OpenTrials
Completed

NCT Number: NCT04792996

Preventive Potential of Bilirubin

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.

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Key information

Conditions

Mild Hyperbilirubinaemia

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention. case - control design.

Primary outcomes

  1. The investigators will consider Lipid parameter

    Time frame: Baseline

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

Secondary outcomes

  1. The investigators will consider plasma parameter of glucose metabolism

    Time frame: 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.

  2. The investigators will consider AMPK metabolic pathway

    Time frame: 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.

  3. The investigators will consider body composition

    Time frame: 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.

  4. The investigators will consider heme catabolic pathway

    Time frame: Baseline

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

  5. The investigators will consider the metabolomic response

    Time frame: 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.

  6. The investigators will consider the composition of gut-microbiota

    Time frame: 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.

  7. The investigators will consider oxidative stress marker

    Time frame: Baseline

    Compare plasma concentrations of oxidative stress marker such as malondialdehyde or GSH/GSSG between Gilbert´s Syndrome subjects and controls.

  8. The investigators will consider anabolic and catabolic hormones

    Time frame: Baseline

    Compare plasma concentrations of hormones (Glucagon (pg/ml), T3 (pg/ml), TSH(µM/ml),) between Gilbert´s Syndrome subjects and controls.

  9. The investigators will consider telomere length

    Time frame: Baseline

    Compare telomere length between Gilbert´s Syndrome subjects and controls.

  10. The investigators will consider RNA and DNA gene expression

    Time frame: Baseline

    Compare RNA and DNA gene expression between Gilbert´s Syndrome subjects and controls.

  11. The investigators will consider the metabolomic response after a standard breakfast

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Vienna

Other

Collaborators

  • Medical University of Vienna

Registry information

Official study title

Investigating the Preventive Potential of Bilirubin

Acronym: BILIHEALTH

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 11, 2021
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.