Non-Alcoholic Fatty Liver Disease
Conditions
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.
Interventions
OTHERCold exposure
Two hours of mild cold exposure using a water-perfused vest
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic lipid content (%) | Six weeks | Magnetic resonance imaging-proton density fat fraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brown adipose tissue volume (ml) / activity (SUVmean) | Six weeks | 18-fluorodeoxyglucose positron emission tomography/ magnetic resonance imaging |
| Basal metabolic rate (kcal/day/kg fat-free body mass) | Six weeks | Indirect calorimetry |
| Cold-induced non-shivering thermogenesis (%) | Six weeks | Indirect calorimetry: percentage increase in basal metabolic rate before and after cold exposure |
| Body fat mass (kg) | Six weeks | Air displacement plethysmography |
| Insulin sensitivity | Six weeks | Matsuda Index for 2 hour standard oral glucose tolerance test |
Countries
Austria
Contacts
Primary ContactFlorian Kiefer, MD, PhD
Outcome results
None listed