Cold-induced Brown Fat Activation and Hepatic Steatosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Hepatic lipid content (%)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •body mass index 28 - 40 kg/m^2
- •hepatic lipid content > 10 %
排除标准
- •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
结局指标
主要结局
Hepatic lipid content (%)
时间窗: Six weeks
Magnetic resonance imaging-proton density fat fraction
次要结局
- Brown adipose tissue volume (ml) / activity (SUVmean)(Six weeks)
- Basal metabolic rate (kcal/day/kg fat-free body mass)(Six weeks)
- Cold-induced non-shivering thermogenesis (%)(Six weeks)
- Body fat mass (kg)(Six weeks)
- Insulin sensitivity(Six weeks)
研究者
Dr. Florian Kiefer
Associate Professor of Medicine
Medical University of Vienna