Rapid Resolution of Human Fatty Liver Disease, the Key to Obesity-related Morbidity and Mortality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Liver fat percent by nuclear magnetic resonance imaging
研究概览
简要总结
The major adverse health consequences of obesity occur only when non-alcoholic fatty liver disease (NAFLD) also develops. NAFLD is characterized by abnormal hepatic accumulation of triglycerides and other lipids. The first-line approach to NAFLD management is caloric restriction and weight loss, but these remain difficult to achieve. Little attention has been given to dietary carbohydrate restriction, despite recent reports showing that hepatic de novo lipogenesis, a process that converts dietary carbohydrates into fatty acids in the postprandial state, accounts for approximately 25% of liver triglyceride content in hyperinsulinemic subjects with NAFLD. For comparison, only 15% of the liver triglycerides were derived from dietary fatty acids in patients with NAFLD who had consumed a standardized 30% fat diet for four days before being assessed.
详细描述
To establish the time-course of hepatic fat loss in NAFLD subjects on a carbohydrate-restricted diet (<20 g/day), a serial assessments of liver fat during two week diet will be performed. Also, markers of lipid and insulin metabolism, liver function test and changes in gut microbiota during rapid metabolic improvement will be assessed.
The overall aim is to exploit this unique set of human material to determine the specific cellular and molecular pathways that are modified in the early stages of metabolic improvement and fatty liver regression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •increased liver fat above 5 % in magnetic resonance spectroscopy
- •body mass index 27-39.9 kg/m2
排除标准
- •liver cirrhosis
- •portal hypertension
- •chronic liver disease other than NAFLD
- •diabetes mellitus or other significant endocrine disease
- •any medication acting on nuclear hormone receptors or inducing liver enzymes or self-administration of supplements other than calcium or vitamins/trace elements
- •any significant cardiovascular co-morbidity
- •history of non-compliance
- •genotype (PNPLA3-MM and TM6SF2-TT) promoting liver fat accumulation
结局指标
主要结局
Liver fat percent by nuclear magnetic resonance imaging
时间窗: 14 days
Liver fat percent measured by nuclear magnetic resonance imaging
次要结局
- De novo lipogenesis measured as Incorporation of new fatty acids (%) to very-low density lipoprotein triglycerides(14 days)
- Gut microbiota measured as change in microbiome profile from baseline(14 days)
研究者
Marja-Riitta Taskinen
Professor
Helsinki University Central Hospital