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Recruiting Not applicable

Cold-induced Brown Fat Activation and Hepatic Steatosis

NCT03811236 · tracked via the Priya Life Science Austria tracker
Phase
Not applicable
Started
2019-01-21
Last updated
2024-03-13

Condition(s) studied

Non-Alcoholic Fatty Liver Disease

Investigational drug(s) / intervention(s)

Cold exposure

Cold exposure: Two hours of mild cold exposure using a water-perfused vest

Study 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

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Hepatic lipid content (%) — Six weeks
    Magnetic resonance imaging-proton density fat fraction

Trial sites (1)

FacilityCityRegionStatus
Medical University of Vienna Vienna Austria Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03811236 on ClinicalTrials.gov ↗ ← All trials in Austria