Low Glycemic Index Mediterranean Diet Effect on Moderate or Severe Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Non-alcoholic Fatty Liver Disease Ultrasonography Score
研究概览
简要总结
Non-alcoholic fatty liver disease (NAFLD) is a clinical/biochemical condition associated with the metabolic syndrome. As the disease stems from excess calorie intake and lack of physical activity, the correction of unhealthy lifestyles is the background of any prevention and treatment strategy
详细描述
The majority of NAFLD patients are characterized by high body mass index, insulin resistance and they show a remarkably higher energy intake in comparison to individuals without hepatic steatosis. Several authors have proposed dietary weight loss strategies to ameliorate or reverse fatty liver because of the potential role of weight loss on the supposed risk factors of liver injury, mainly insulin resistance, free fatty acid levels, and pro-inflammatory and profibrotic adipokines. There are no definite data regarding how much and how rapidly weight loss should be to have the more favorable effects, but in obese children, the larger the weight loss, the larger the decrease of liver enzyme levels and the lower the prevalence of NAFLD. The American Gastroenterological Association recommends a weight loss target of 10% of baseline. A loss of at least 10% of body weight in obese patients is associated with a normalization of previously abnormal liver function tests as well as decreased hepatomegaly, but even a moderate weight loss (approximately 6% of baseline weight) can improve insulin resistance and intrahepatic liver content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject enrolled in the cohort Nutriep assembled in 2005-2007
- •Moderate or severe NAFLD
排除标准
- •Middle NAFLD
- •Not enrolled in the Nutriep cohort
- •Pregnancy
结局指标
主要结局
Non-alcoholic Fatty Liver Disease Ultrasonography Score
时间窗: Six months
A semiquantitative score to measure Non-alcoholic Fatty Liver Disease will be used
次要结局
未报告次要终点
研究者
Alberto R Osella
Senior Researcher
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
