NCT03811236 Cold-induced Brown Fat Activation and Hepatic Steatosis
| NCT ID | NCT03811236 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Non-Alcoholic Fatty Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2019-01-21 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 26 participants in total. It began in 2019-01-21 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In the recent years, research on brown adipose tissue (BAT) revealed that larger amounts as well as higher activity thereof are associated with a favourable metabolic phenotype. Longitudinal studies which applied recurrent cooling sessions demonstrated a high plasticity of BAT which significantly increased in size and activity during these studies. These changes were accompanied by improvements in body fat mass as well as insulin sensitivity. Non-alcoholic fatty liver disease (NAFLD) is estimated to advance to the primary cause of liver cirrhosis and hepatocellular carcinoma in the following years. Besides predisposing genetic and possibly nutritional factors, the insulin resistance syndrome and obesity are the main factors contributing to this excessive hepatic lipid accumulation. The aim of this study is to investigate whether BAT recruitment via cold-acclimation results in decreased hepatic lipid content in overweight/obese patients with NAFLD.
Eligibility 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
Contact & Investigator
Florian Kiefer, MD, PhD
PRINCIPAL INVESTIGATOR
Medical University of Vienna
Frequently Asked Questions
Who can join the NCT03811236 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Non-Alcoholic Fatty Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03811236 currently recruiting?
Yes, NCT03811236 is actively recruiting participants. Contact the research team at florian.kiefer@meduniwien.ac.at for enrollment information.
Where is the NCT03811236 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT03811236 clinical trial?
NCT03811236 is sponsored by Medical University of Vienna. The principal investigator is Florian Kiefer, MD, PhD at Medical University of Vienna. The trial plans to enroll 26 participants.