Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06336369

Energy Metabolism and Brown Adipose Tissue Activity in Individuals With Gilbert's Syndrome and Healthy Controls

Led by Medical University of Vienna · Updated on 2024-03-28

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Medical University of Vienna

Lead Sponsor

U

University of Vienna

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research investigates the relationship between bilirubin metabolism and metabolic health by comparing individuals with Gilbert's syndrome (GS) to healthy controls. The study focuses on energy metabolism, body composition, and the activity of brown adipose tissue (BAT) in these two groups. Researchers aim to understand why people with GS show a distinct metabolic profile linked to mildly elevated bilirubin levels and its potential health effects. Participants will undergo several diagnostic procedures over three separate days. These include cold exposure to stimulate brown fat, PET-CT imaging to assess BAT, MRI scans of the liver, abdominal fat, and muscle, blood sampling, indirect calorimetry to measure energy expenditure, bioelectrical impedance analysis for body composition, and infrared thermography. The study groups consist of 40 individuals with GS and 40 matched controls based on age and gender, distinguished by their bilirubin blood levels. Each participant will attend three study days involving fasting before key measurements. On the first day, brown adipose tissue activity is measured; on the second day, fat distribution in the liver and muscle is assessed. Participants also complete dietary and physical activity questionnaires. The primary outcome is the activation of brown adipose tissue induced by cold over 12 hours across the three days. Researchers will monitor metabolic health, body composition, and BAT activity to compare GS individuals with controls. The study is conducted by the Medical University of Vienna and lasts approximately three days per participant.

CONDITIONS

Brief Title

Brown Adipose Tissue Activity in Gilbert's Syndrome

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Written consent provided
  • Age between 18 and 65 years
  • Liver markers (AST, ALT, GGT) less than twice the upper normal range
  • Non-smoker
  • Moderate physical activity level
  • Ability to understand study requirements
  • For cases: total bilirubin in blood greater than 1.2 mg/dL and unconjugated bilirubin greater than 1 mg/dL
  • For controls: total bilirubin in blood less than or equal to 1.2 mg/dL and unconjugated bilirubin less than or equal to 1 mg/dL
Not Eligible

You will not qualify if you...

  • Age below 18 or above 65 years
  • Current or past heart, lung, metabolic, or muscle diseases
  • Breastfeeding or current/potential pregnancy
  • Liver diseases including hepatitis A and B
  • Kidney diseases
  • Active tumor disease
  • History of organ transplant
  • Unwillingness to meet study demands
  • Not weight stable (more than ±5% change) in past 3 months
  • Any condition or medication that may cause personal risk, study bias, or affect liver markers within last 5 weeks
  • For cases: total bilirubin less than or equal to 1.2 mg/dL or unconjugated bilirubin less than or equal to 1 mg/dL
  • For controls: total bilirubin greater than 1.2 mg/dL or unconjugated bilirubin greater than 1 mg/dL

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 3 independent days

Participants undergo testing including blood sampling, cooling procedure, PET-CT imaging, MR imaging, indirect calorimetry, thermography, and impedance analysis to assess brown adipose tissue activity and fat distribution.

3 visits (in-person) over 3 separate days

Trial Site Locations

Total: 1 location

1

Medical University of Vienna

Vienna, Austria, 1090

Actively Recruiting

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Research Team

K

Karl-Heinz Wagner, Univ.-Prof. Mag.

F

Florian Kiefer, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

Looking to the horizon: the role of bilirubin in the development and prevention of age-related chronic diseases.

Karl-Heinz Wagner, Marlies Wallner, Christine Mölzer...

https://pubmed.ncbi.nlm.nih.gov/25881719