Preventive Potential of Bilirubin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-01

Study Completion Date

2016-06-01

Brief Summary

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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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Detailed Description

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Conditions

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Mild Hyperbilirubinaemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Gilbert´s Syndrome

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

No intervention

Intervention Type OTHER

No intervention. case - control design.

Control group

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

No intervention

Intervention Type OTHER

No intervention. case - control design.

Interventions

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No intervention

No intervention. case - control design.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No