Investigating brown fat activity in people with Gilbert's syndrome
BiliMetHealth- Energy Metabolism and Brown Adipose Tissue (BAT) Activity in Individuals With Gilbert's Syndrome (GS) and Healthy Controls
This study is trying to see how brown fat activity and bilirubin levels in people with Gilbert's syndrome compare to healthy individuals to better understand their metabolic health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06336369 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between bilirubin metabolism and metabolic health by comparing individuals with Gilbert's syndrome to healthy controls. Participants will undergo various assessments including cold exposure, PET-CT imaging, MRI, blood sampling, and indirect calorimetry to evaluate energy metabolism, body composition, and brown adipose tissue activity. The study seeks to understand how mildly elevated bilirubin levels may influence metabolic health and reduce the risk of certain diseases.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 65 with Gilbert's syndrome characterized by elevated bilirubin levels.
Not a fit: Patients with significant liver or metabolic diseases, or those outside the specified age range, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how Gilbert's syndrome may confer metabolic advantages and inform new approaches to managing metabolic health.
How similar studies have performed: While studies on bilirubin's effects on health exist, this specific investigation into brown adipose tissue activity in Gilbert's syndrome is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Karl-Heinz Wagner, Univ.-Prof. Mag. — University of Vienna
- Study coordinator: Karl-Heinz Wagner, Univ.-Prof. Mag.
- Email: karl-heinz.wagner@univie.ac.at
- Phone: +43-1- 4277 - 54930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.