Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06336369

Brown Adipose Tissue Activity in Gilbert's Syndrome

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

80

Participants Needed

1

Research Sites

149 weeks

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

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.

CONDITIONS

Official 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...

  • Age between 18 and 65 years
  • Written consent to participate
  • Liver markers (AST, ALT, GGT) less than twice the upper normal limit
  • Non-smoker
  • Moderate physical activity level
  • Ability to understand study requirements
  • For Gilbert's syndrome group: total bilirubin in blood above 1.2 mg/dL and unconjugated bilirubin above 1 mg/dL
  • For control group: total bilirubin in blood 1.2 mg/dL or below and unconjugated bilirubin 1 mg/dL or below
Not Eligible

You will not qualify if you...

  • Age below 18 or above 65 years
  • Current or past heart, lung, metabolic, or musculoskeletal disease
  • Breastfeeding or pregnant
  • Liver diseases including hepatitis A and B
  • Kidney diseases
  • Active tumor disease
  • Organ transplant recipients
  • Unwillingness to meet study demands
  • Body weight not stable within ±5% for at least 3 months before study
  • Any condition or behavior, including medication, posing personal risk or biasing results
  • For Gilbert's syndrome group: total bilirubin in blood 1.2 mg/dL or below or unconjugated bilirubin 1 mg/dL or below
  • For control group: total bilirubin in blood above 1.2 mg/dL or unconjugated bilirubin above 1 mg/dL

AI-Screening

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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.

CONTACT

F

Florian Kiefer, MD, PhD

CONTACT

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

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