Cold-induced Brown Fat Activation and Hepatic Steatosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cold exposure.
- Who it may be relevant to
- Registry conditions: Non-Alcoholic Fatty Liver Disease. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Cold exposure
Two hours of mild cold exposure using a water-perfused vest
Primary outcome measures
- Hepatic lipid content (%) [Time frame: Six weeks]
Secondary outcome measures (5)
- Brown adipose tissue volume (ml) / activity (SUVmean) [Time frame: Six weeks]
- Basal metabolic rate (kcal/day/kg fat-free body mass) [Time frame: Six weeks]
- Cold-induced non-shivering thermogenesis (%) [Time frame: Six weeks]
- Body fat mass (kg) [Time frame: Six weeks]
- Insulin sensitivity [Time frame: Six weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Austria · 1 center
- Medical University of Vienna — Vienna
Identifiers
NCT: NCT03811236 · 1911/2017