Using cold exposure to activate brown fat and reduce liver fat
Cold-induced Brown Fat Activation and Hepatic Steatosis
This study tests if exposing overweight and obese people with fatty liver disease to cold can help activate their brown fat and reduce fat in their liver.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT03811236 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of cold exposure on brown adipose tissue (BAT) activation in overweight and obese patients with non-alcoholic fatty liver disease (NAFLD). The research aims to determine if recruiting BAT through cold acclimation can lead to a decrease in hepatic lipid content. Participants will undergo recurrent cooling sessions to assess changes in BAT size and activity, as well as improvements in metabolic health markers. The study focuses on the relationship between BAT and liver fat accumulation, which is critical for addressing the rising prevalence of NAFLD.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese individuals with a body mass index between 28 and 40 kg/m² and hepatic lipid content greater than 10%.
Not a fit: Patients with endocrine diseases, chronic kidney disease, active malignancies, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel non-invasive treatment option for patients with NAFLD, potentially reducing liver fat and improving metabolic health.
How similar studies have performed: While the concept of BAT activation through cold exposure is promising, this specific approach in relation to NAFLD is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * body mass index 28 - 40 kg/m\^2 * hepatic lipid content \> 10 % Exclusion Criteria: * endocrine disease, except treated hypo-/hyperthyroidism and hypertriglyceridemia (\<500 mg/dl) and untreated type II diabetes mellitus (fasting glucose \< 140 mg/dl) * use of beta-blockers, alpha-blockers and rilmenidine * chronic kidney disease * inflammatory bowel disease * active malignant disease * autoimmune disease * chronic alcohol abuse or alcohol consumption greater than 30g/d for men or 20 g/d for women * transferrin saturation \> 40% * serum alpha-1 antitrypsin \< 90 mg/dl * serum ceruloplasmin \< 20 mg/dl * positive serology for autoimmune hepatitis * positive hepatitis serology * liver cirrhosis * portal hypertension * pregnancy * contraindications for magnetic resonance imaging
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Florian Kiefer, MD, PhD — Medical University of Vienna
- Study coordinator: Florian Kiefer, MD, PhD
- Email: florian.kiefer@meduniwien.ac.at
- Phone: +43140400
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.