Preventive Potential of Bilirubin

Mild Hyperbilirubinaemia Clinical Trial

— BILIHEALTH  

Official title:

Investigating the Preventive Potential of Bilirubin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792996
• Other study ID #: UNIVIE-BILIHEALTH
• Status: Completed
• Start date: June 1, 2014
• Est. completion date: June 1, 2016

Study information

• Verified date: March 2021
• Source: University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 1, 2016
• Est. primary completion date: June 1, 2016
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Mild Hyperbilirubinaemia

Intervention

Other:
• No intervention
No intervention. case - control design.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Vienna	Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The investigators will consider Lipid parameter	Compare plasma parameter of lipid metabolism (Cholesterol, LDL, HDL, Triglycerides, ..) between Gilbert´s Syndrome subjects and controls.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	The investigators will consider the composition of gut-microbiota	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.	Baseline
Secondary	The investigators will consider oxidative stress marker	Compare plasma concentrations of oxidative stress marker such as malondialdehyde or GSH/GSSG between Gilbert´s Syndrome subjects and controls.	Baseline
Secondary	The investigators will consider anabolic and catabolic hormones	Compare plasma concentrations of hormones (Glucagon (pg/ml), T3 (pg/ml), TSH(µM/ml),) between Gilbert´s Syndrome subjects and controls.	Baseline
Secondary	The investigators will consider telomere length	Compare telomere length between Gilbert´s Syndrome subjects and controls.	Baseline
Secondary	The investigators will consider RNA and DNA gene expression	Compare RNA and DNA gene expression between Gilbert´s Syndrome subjects and controls.	Baseline
Secondary	The investigators will consider the metabolomic response after a standard breakfast	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.	Five blood samplings over 180 minutes.