Gilbert SyndromeNCT06336369
Brown Adipose Tissue Activity in Gilbert's Syndrome
An observational study of Gilbert Syndrome, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The goal of this case-control study is to investigate energy metabolism and brown adipose tissue (BAT) activity in individuals with Gilbert's syndrome (GS) and controls. The main focus of the study is to analyze: 1. the link between bilirubin metabolism and metabolic health. 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gilbert Syndrome
- What is being tested?
- analyzing brown adipose tissue, body composition and metabolic health
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 6 Mar 2024to 5 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: cohort from previous study
Who may be able to join
- written consent, age between 18 and 65 years of age, liver marker (AST, ALT, GGT) < 2x of the upper norm range, non-smoker, moderate physical activity, ability to understand the requirements of the course of study
- Cases: (Gilbert-Syndrom):
- Total bilirubin in the blood > 1.2 mg/dL (17.1 μM)
- Unconjugated (indirect bilirubin) > 1 mg/dL
- Controls (non-Gilbert-Syndrom):
- Total bilirubin in the blood ≤ 1.2 mg/dL (17.1 μM)
- Unconjugated (indirect bilirubin) ≤ 1 mg/dL
Who cannot join
- age < 18 or > 65 years; having current or any history of cardio-pulmonary, metabolic or musculoskeletal disease; breastfeeding or was/potentially pregnant; liver diseases incl. hep A and B; kidney diseases; active tumor disease; persons with an organ transplant; not willing to meet the demands of the study; not being weight stable (± 5% body mass; self-reported) for at least the 3 months prior to their involvement; or any conditions or concurrent behaviour (including medication) that may have posed undue personal risk to the participant, introduce bias to the study or were influencing liver marker in the last 5 weeks.
- Cases: (Gilbert-Syndrom):
- Total bilirubin in the blood ≤ 1.2 mg/dL (17.1 μM)
- Unconjugated (indirect bilirubin) ≤ 1 mg/dL
- Controls (non-Gilbert-Syndrom):
- Total bilirubin in the blood > 1.2 mg/dL (17.1 μM)
- Unconjugated (indirect bilirubin) > 1 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BiliMetHealth- Energy Metabolism and Brown Adipose Tissue (BAT) Activity in Individuals With Gilbert's Syndrome (GS) and Healthy Controls
The goal of this case-control study is to investigate energy metabolism and brown adipose tissue (BAT) activity in individuals with Gilbert's syndrome (GS) and controls. The main focus of the study is to analyze:
- the link between bilirubin metabolism and metabolic health.
- energy metabolism and body composition in individuals with Gilbert's syndrome and control subjects
- brown adipose tissue activity in Gilbert's syndrome and healthy controls.
Read more
Participants will undergo the following investigations:
- cold exposure
- PET-CT imaging with 18-F-FDG
- MRI imaging of liver, abdominal fat and muscle
- blood sampling
- indirect calorimetry
- bioelectrical impedance analysis
- infrared thermography
Researchers will compare individuals with GS and control subjects in terms of metabolic health, body composition and BAT activity.
Read the detailed description
Bilirubin has long been associated with liver pathology and haemolytic conditions and was until recently assumed to possess little or no biological function. However, unconjugated bilirubin (UCB) rarely approaches these toxic levels and approximates 10 μM in the general population, which is 30-60 times below the reported toxic threshold.
The beneficial associations of mildly elevated blood UCB concentrations with diseases of civilization (in particular those affecting the cardiovascular system and all-cause mortality) have been reported in numerous studies. In addition, a mildly elevated UCB is also associated with reduced adiposity, decreased risk of metabolic syndrome, non-alcoholic fatty liver disease and diabetes as well as overall cancer risk. Bilirubin downregulates pro-inflammatory responses often observed in disease, which complements epidemiological evidence of reduced inflammatory, autoimmune, and degenerative diseases in individuals with GS. Together, these observations may account for the reduced all-cause mortality rates reported in those with GS compared to the normobilirubinaemic population. Finally, bilirubin has been recently reported to modulate cell signalling and act as an endocrine molecule. The investigators were amongst the first to show that - bile pigments possess substantial anti-mutagenic in vitro and ex vivo antioxidant capacity; - subjects with mild hyperbilirubinaemia - also called Gilbert ́s Syndrome (GS) have a significantly reduced BMI compared to age and gender matched controls, a lower hip circumference (HC) as well as lower total/LDL cholesterol, triglycerides and low- and pro-atherogenic sub fractions as well as IL-6. Interestingly effects of GS in older participants (≥35yrs) is most profound, with substantially reduced anthropometric data and improved lipid profile.
Very recently the investigators and others showed that enhanced lipid catabolism in GS seems to be the key mechanism involved.
Based on these very preliminary observations, and the strong link between bilirubin metabolism and metabolic health the investigators aim to investigate in this application more deeply mechanistic questions to better understand why GS subjects show the very specific phenotype and its metabolic potential.
Here the investigators propose a human case control study. Therefore the investigators will investigate 40 GS individuals vs. 40 age and gender matched controls. Participants will be recruited as performed in previous studies.
Cases: (Gilbert-Syndrom):
- Total bilirubin in the blood > 1.2 mg/dL (17.1 μM)
- Unconjugated (indirect bilirubin) > 1 mg/dL
Controls (non-Gilbert-Syndrom):
- Total bilirubin in the blood ≤ 1.2 mg/dL (17.1 μM)
- Unconjugated (indirect bilirubin) ≤ 1 mg/dL
The duration of the study lasts for every participant 3 independent days. On the preinvestigation-day a screening will be performed including a blood sampling to prove in- and exclusion criteria.
On study day 1 participants must be fastened and will undergo the measurement of the brown adipose tissue.
On study day 2 participants must be fastened and will undergo the measurement of fat distribution in liver and muscle.
One 24-hr recall, a FFQ and a physical activity questionnaire will be assessed at the beginning of study day 1.
- Conditions
- Gilbert Syndrome
- Being tested
- analyzing brown adipose tissue, body composition and metabolic health
- Medical subject headings
- Gilbert Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analyzing brown adipose tissue, body composition and metabolic healthDiagnostic test
cooling procedure, PET-CT imaging, MR imaging, blood sampling, indirect calorimetry, thermograpy, impedance analysis
| Study group | Role | What they receive |
|---|---|---|
| Cases | Cases: (Gilbert-Syndrom):
* Total bilirubin in the blood > 1.2 mg/dL (17.1 μM)
* Unconjugated (indirect bilirubin) > 1 mg/dL Receives: Diagnostic Test: analyzing brown adipose tissue, body composition and metabolic health | |
| Controls | Controls (non-Gilbert-Syndrom):
* Total bilirubin in the blood ≤ 1.2 mg/dL (17.1 μM)
* Unconjugated (indirect bilirubin) ≤ 1 mg/dL Receives: Diagnostic Test: analyzing brown adipose tissue, body composition and metabolic health |
What is being measured
The primary outcome is the main question the study is designed to answer.
cold-induced brown adipose tissue (BAT) activation
proven via PET-CT imaging due to radioactive tracer uptake (18-F-FDG)
Measured: 3 independent days, 12 hours in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start6 Mar 2024
- Primary completion15 Sep 2026
- Study completion5 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Gilbert SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vienna, Griffith University
- Responsible party
- Principal investigator, Dr. Florian Kiefer, Medical University of Vienna
- Investigators
- Karl-Heinz Wagner, Univ.-Prof. Mag., Principal investigator, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336369
- Sponsor's protocol ID
- 1713/2023
- Status last verified
- Oct 2026
- First submitted
- 21 Mar 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bulmer AC, Blanchfield JT, Toth I, Fassett RG, Coombes JS. Improved resistance to serum oxidation in Gilbert's syndrome: a mechanism for cardiovascular protection. Atherosclerosis. 2008 Aug;199(2):390-6. doi: 10.1016/j.atherosclerosis.2007.11.022. Epub 2007 Dec 26.
PubMed 18155709Wagner KH, Wallner M, Molzer C, Gazzin S, Bulmer AC, Tiribelli C, Vitek L. Looking to the horizon: the role of bilirubin in the development and prevention of age-related chronic diseases. Clin Sci (Lond). 2015 Jul;129(1):1-25. doi: 10.1042/CS20140566.
PubMed 25881719Wagner KH, Shiels RG, Lang CA, Seyed Khoei N, Bulmer AC. Diagnostic criteria and contributors to Gilbert's syndrome. Crit Rev Clin Lab Sci. 2018 Mar;55(2):129-139. doi: 10.1080/10408363.2018.1428526. Epub 2018 Feb 1.
PubMed 29390925Vitek L. The role of bilirubin in diabetes, metabolic syndrome, and cardiovascular diseases. Front Pharmacol. 2012 Apr 3;3:55. doi: 10.3389/fphar.2012.00055. eCollection 2012.
PubMed 22493581Vitek L. Bilirubin and atherosclerotic diseases. Physiol Res. 2017 Apr 5;66(Suppl 1):S11-S20. doi: 10.33549/physiolres.933581.
PubMed 28379026Weaver L, Hamoud AR, Stec DE, Hinds TD Jr. Biliverdin reductase and bilirubin in hepatic disease. Am J Physiol Gastrointest Liver Physiol. 2018 Jun 1;314(6):G668-G676. doi: 10.1152/ajpgi.00026.2018. Epub 2018 Mar 1.
PubMed 29494209Jangi S, Otterbein L, Robson S. The molecular basis for the immunomodulatory activities of unconjugated bilirubin. Int J Biochem Cell Biol. 2013 Dec;45(12):2843-51. doi: 10.1016/j.biocel.2013.09.014. Epub 2013 Oct 19.
PubMed 24144577Horsfall LJ, Nazareth I, Pereira SP, Petersen I. Gilbert's syndrome and the risk of death: a population-based cohort study. J Gastroenterol Hepatol. 2013 Oct;28(10):1643-7. doi: 10.1111/jgh.12279.
PubMed 23701650Vitek L, Haluzik M. The role of bile acids in metabolic regulation. J Endocrinol. 2016 Mar;228(3):R85-96. doi: 10.1530/JOE-15-0469. Epub 2016 Jan 5.
PubMed 26733603Bulmer AC, Ried K, Blanchfield JT, Wagner KH. The anti-mutagenic properties of bile pigments. Mutat Res. 2008 Jan-Feb;658(1-2):28-41. doi: 10.1016/j.mrrev.2007.05.001. Epub 2007 May 18.
PubMed 17602853Bulmer AC, Ried K, Coombes JS, Blanchfield JT, Toth I, Wagner KH. The anti-mutagenic and antioxidant effects of bile pigments in the Ames Salmonella test. Mutat Res. 2007 May 18;629(2):122-32. doi: 10.1016/j.mrgentox.2007.01.008. Epub 2007 Feb 11.
PubMed 17350329Wallner M, Blassnigg SM, Marisch K, Pappenheim MT, Mullner E, Molzer C, Nersesyan A, Marculescu R, Doberer D, Knasmuller S, Bulmer AC, Wagner KH. Effects of unconjugated bilirubin on chromosomal damage in individuals with Gilbert's syndrome measured with the micronucleus cytome assay. Mutagenesis. 2012 Nov;27(6):731-5. doi: 10.1093/mutage/ges039. Epub 2012 Aug 8.
PubMed 22874647Wallner M, Antl N, Rittmannsberger B, Schreidl S, Najafi K, Mullner E, Molzer C, Ferk F, Knasmuller S, Marculescu R, Doberer D, Poulsen HE, Vitek L, Bulmer AC, Wagner KH. Anti-genotoxic potential of bilirubin in vivo: damage to DNA in hyperbilirubinemic human and animal models. Cancer Prev Res (Phila). 2013 Oct;6(10):1056-63. doi: 10.1158/1940-6207.CAPR-13-0125. Epub 2013 Aug 27.
PubMed 23983086Seyed Khoei N, Grindel A, Wallner M, Molzer C, Doberer D, Marculescu R, Bulmer A, Wagner KH. Mild hyperbilirubinaemia as an endogenous mitigator of overweight and obesity: Implications for improved metabolic health. Atherosclerosis. 2018 Feb;269:306-311. doi: 10.1016/j.atherosclerosis.2017.12.021. Epub 2017 Dec 14.
PubMed 29279144Wallner M, Marculescu R, Doberer D, Wolzt M, Wagner O, Vitek L, Bulmer AC, Wagner KH. Protection from age-related increase in lipid biomarkers and inflammation contributes to cardiovascular protection in Gilbert's syndrome. Clin Sci (Lond). 2013 Sep;125(5):257-64. doi: 10.1042/CS20120661.
PubMed 23566065
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BiliMetHealth- Energy Metabolism and Brown Adipose Tissue (BAT) Activity in Individuals With Gilbert's Syndrome (GS) and Healthy Controls
- ClinicalTrials.gov ID
- NCT06336369
- Acronym / sponsor ID
- 1713/2023
- Conditions
- Gilbert Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- University of Vienna, Griffith University
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 5 Oct 2026 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this case-control study is to investigate energy metabolism and brown adipose tissue (BAT) activity in individuals with Gilbert's syndrome (GS) and controls. The main focus of the study is to analyze:
- the link between bilirubin metabolism and metabolic health.
- energy metabolism and body composition in individuals with Gilbert's syndrome and control subjects
- brown adipose tissue activity in Gilbert's syndrome and healthy controls.
Participants will undergo the following investigations:
- cold exposure
- PET-CT imaging with 18-F-FDG
- MRI imaging of liver, abdominal fat and muscle
- blood sampling
- indirect calorimetry
- bioelectrical impedance analysis
- infrared thermography
Researchers will compare individuals with GS and control subjects in terms of metabolic health, body composition and BAT activity.
Detailed description
Bilirubin has long been associated with liver pathology and haemolytic conditions and was until recently assumed to possess little or no biological function. However, unconjugated bilirubin (UCB) rarely approaches these toxic levels and approximates 10 μM in the general population, which is 30-60 times below the reported toxic threshold.
The beneficial associations of mildly elevated blood UCB concentrations with diseases of civilization (in particular those affecting the cardiovascular system and all-cause mortality) have been reported in numerous studies. In addition, a mildly elevated UCB is also associated with reduced adiposity, decreased risk of metabolic syndrome, non-alcoholic fatty liver disease and diabetes as well as overall cancer risk. Bilirubin downregulates pro-inflammatory responses often observed in disease, which complements epidemiological evidence of reduced inflammatory, autoimmune, and degenerative diseases in individuals with GS. Together, these observations may account for the reduced all-cause mortality rates reported in those with GS compared to the normobilirubinaemic population. Finally, bilirubin has been recently reported to modulate cell signalling and act as an endocrine molecule. The investigators were amongst the first to show that - bile pigments possess substantial anti-mutagenic in vitro and ex vivo antioxidant capacity; - subjects with mild hyperbilirubinaemia - also called Gilbert ́s Syndrome (GS) have a significantly reduced BMI compared to age and gender matched controls, a lower hip circumference (HC) as well as lower total/LDL cholesterol, triglycerides and low- and pro-atherogenic sub fractions as well as IL-6. Interestingly effects of GS in older participants (≥35yrs) is most profound, with substantially reduced anthropometric data and improved lipid profile.
Very recently the investigators and others showed that enhanced lipid catabolism in GS seems to be the key mechanism involved.
Based on these very preliminary observations, and the strong link between bilirubin metabolism and metabolic health the investigators aim to investigate in this application more deeply mechanistic questions to better understand why GS subjects show the very specific phenotype and its metabolic potential.
Here the investigators propose a human case control study. Therefore the investigators will investigate 40 GS individuals vs. 40 age and gender matched controls. Participants will be recruited as performed in previous studies.
Cases: (Gilbert-Syndrom):
- Total bilirubin in the blood > 1.2 mg/dL (17.1 μM)
- Unconjugated (indirect bilirubin) > 1 mg/dL
Controls (non-Gilbert-Syndrom):
- Total bilirubin in the blood ≤ 1.2 mg/dL (17.1 μM)
- Unconjugated (indirect bilirubin) ≤ 1 mg/dL
The duration of the study lasts for every participant 3 independent days. On the preinvestigation-day a screening will be performed including a blood sampling to prove in- and exclusion criteria.
On study day 1 participants must be fastened and will undergo the measurement of the brown adipose tissue.
On study day 2 participants must be fastened and will undergo the measurement of fat distribution in liver and muscle.
One 24-hr recall, a FFQ and a physical activity questionnaire will be assessed at the beginning of study day 1.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: analyzing brown adipose tissue, body composition and metabolic healthCases: (Gilbert-Syndrom): * Total bilirubin in the blood > 1.2 mg/dL (17.1 μM) * Unconjugated (indirect bilirubin) > 1 mg/dL |
| Controls | – | Diagnostic Test: analyzing brown adipose tissue, body composition and metabolic healthControls (non-Gilbert-Syndrom): * Total bilirubin in the blood ≤ 1.2 mg/dL (17.1 μM) * Unconjugated (indirect bilirubin) ≤ 1 mg/dL |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- cohort from previous study
Key inclusion criteria (7 listed)
- written consent, age between 18 and 65 years of age, liver marker (AST, ALT, GGT) < 2x of the upper norm range, non-smoker, moderate physical activity, ability to understand the requirements of the course of study
- Total bilirubin in the blood > 1.2 mg/dL (17.1 μM)
- Unconjugated (indirect bilirubin) > 1 mg/dL
- Total bilirubin in the blood ≤ 1.2 mg/dL (17.1 μM)
- Unconjugated (indirect bilirubin) ≤ 1 mg/dL
Key exclusion criteria (7 listed)
- age < 18 or > 65 years; having current or any history of cardio-pulmonary, metabolic or musculoskeletal disease; breastfeeding or was/potentially pregnant; liver diseases incl. hep A and B; kidney diseases; active tumor disease; persons with an organ transplant; not willing to meet the demands of the study; not being weight stable (± 5% body mass; self-reported) for at least the 3 months prior to their involvement; or any conditions or concurrent behaviour (including medication) that may have posed undue personal risk to the participant, introduce bias to the study or were influencing liver marker in the last 5 weeks.
- Total bilirubin in the blood ≤ 1.2 mg/dL (17.1 μM)
- Unconjugated (indirect bilirubin) ≤ 1 mg/dL
- Total bilirubin in the blood > 1.2 mg/dL (17.1 μM)
- Unconjugated (indirect bilirubin) > 1 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analyzing brown adipose tissue, body composition and metabolic healthcooling procedure, PET-CT imaging, MR imaging, blood sampling, indirect calorimetry, thermograpy, impedance analysis | Diagnostic test | Cases, Controls |
Primary outcome
cold-induced brown adipose tissue (BAT) activation
Time frame: 3 independent days, 12 hours in total
proven via PET-CT imaging due to radioactive tracer uptake (18-F-FDG)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 18155709Bulmer AC, Blanchfield JT, Toth I, Fassett RG, Coombes JS. Improved resistance to serum oxidation in Gilbert's syndrome: a mechanism for cardiovascular protection. Atherosclerosis. 2008 Aug;199(2):390-6. doi: 10.1016/j.atherosclerosis.2007.11.022. Epub 2007 Dec 26.
- Background: PubMed 25881719Wagner KH, Wallner M, Molzer C, Gazzin S, Bulmer AC, Tiribelli C, Vitek L. Looking to the horizon: the role of bilirubin in the development and prevention of age-related chronic diseases. Clin Sci (Lond). 2015 Jul;129(1):1-25. doi: 10.1042/CS20140566.
- Background: PubMed 29390925Wagner KH, Shiels RG, Lang CA, Seyed Khoei N, Bulmer AC. Diagnostic criteria and contributors to Gilbert's syndrome. Crit Rev Clin Lab Sci. 2018 Mar;55(2):129-139. doi: 10.1080/10408363.2018.1428526. Epub 2018 Feb 1.
- Background: PubMed 22493581Vitek L. The role of bilirubin in diabetes, metabolic syndrome, and cardiovascular diseases. Front Pharmacol. 2012 Apr 3;3:55. doi: 10.3389/fphar.2012.00055. eCollection 2012.
- Background: PubMed 28379026Vitek L. Bilirubin and atherosclerotic diseases. Physiol Res. 2017 Apr 5;66(Suppl 1):S11-S20. doi: 10.33549/physiolres.933581.
- Background: PubMed 29494209Weaver L, Hamoud AR, Stec DE, Hinds TD Jr. Biliverdin reductase and bilirubin in hepatic disease. Am J Physiol Gastrointest Liver Physiol. 2018 Jun 1;314(6):G668-G676. doi: 10.1152/ajpgi.00026.2018. Epub 2018 Mar 1.
- Background: PubMed 24144577Jangi S, Otterbein L, Robson S. The molecular basis for the immunomodulatory activities of unconjugated bilirubin. Int J Biochem Cell Biol. 2013 Dec;45(12):2843-51. doi: 10.1016/j.biocel.2013.09.014. Epub 2013 Oct 19.
- Background: PubMed 23701650Horsfall LJ, Nazareth I, Pereira SP, Petersen I. Gilbert's syndrome and the risk of death: a population-based cohort study. J Gastroenterol Hepatol. 2013 Oct;28(10):1643-7. doi: 10.1111/jgh.12279.
- Background: PubMed 26733603Vitek L, Haluzik M. The role of bile acids in metabolic regulation. J Endocrinol. 2016 Mar;228(3):R85-96. doi: 10.1530/JOE-15-0469. Epub 2016 Jan 5.
- Background: PubMed 17602853Bulmer AC, Ried K, Blanchfield JT, Wagner KH. The anti-mutagenic properties of bile pigments. Mutat Res. 2008 Jan-Feb;658(1-2):28-41. doi: 10.1016/j.mrrev.2007.05.001. Epub 2007 May 18.
- Background: PubMed 17350329Bulmer AC, Ried K, Coombes JS, Blanchfield JT, Toth I, Wagner KH. The anti-mutagenic and antioxidant effects of bile pigments in the Ames Salmonella test. Mutat Res. 2007 May 18;629(2):122-32. doi: 10.1016/j.mrgentox.2007.01.008. Epub 2007 Feb 11.
- Background: PubMed 22874647Wallner M, Blassnigg SM, Marisch K, Pappenheim MT, Mullner E, Molzer C, Nersesyan A, Marculescu R, Doberer D, Knasmuller S, Bulmer AC, Wagner KH. Effects of unconjugated bilirubin on chromosomal damage in individuals with Gilbert's syndrome measured with the micronucleus cytome assay. Mutagenesis. 2012 Nov;27(6):731-5. doi: 10.1093/mutage/ges039. Epub 2012 Aug 8.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl-Heinz Wagner, Univ.-Prof. Mag. principal investigator
University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gilbert Syndrome, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cold-induced brown adipose tissue (BAT) activation (time frame: 3 independent days, 12 hours in total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06336369, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.