Brown Adipose Tissue Activity in Gilbert's Syndrome (NCT06336369) | Clinical Trial Compass
RecruitingNot Applicable
Brown Adipose Tissue Activity in Gilbert's Syndrome
Austria80 participantsStarted 2024-03-06
Plain-language 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. energy metabolism and body composition in individuals with Gilbert's syndrome and control subjects
3. brown adipose tissue activity in Gilbert's syndrome and healthy controls.
Participants will undergo the following investigations:
1. cold exposure
2. PET-CT imaging with 18-F-FDG
3. MRI imaging of liver, abdominal fat and muscle
4. blood sampling
5. indirect calorimetry
6. bioelectrical impedance analysis
7. infrared thermography
Researchers will compare individuals with GS and control subjects in terms of metabolic health, body composition and BAT activity.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
cold-induced brown adipose tissue (BAT) activation