Formula Diet Treatment for Weight Reduction in NASH Patients.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- degree of steatosis
研究概览
简要总结
Non-alcoholic steatohepatitis (NASH) - also called fatty liver - is medically a serious problem because the liver tissue becomes fatty and stiff, and inflammatory reactions occur. This increases the risk of liver fibrosis (= scarring of the liver), liver cirrhosis (= shrunken liver), a liver tumor or death. So far there is no recognized treatment option for this disease. However, there is evidence that a lifestyle change based on a reduced carbohydrate diet, more exercise and a significant weight loss that can improve NASH.
详细描述
Outpatients with NASH will be included into this lifestyle intervention study. Patients will get nutritional advices and a formula diet for 12 weeks. Clinical visits will take place at baseline, after 4, 12 and after 52 weeks.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI>25 kg/qm
排除标准
- •history of drug or alcohol abuse
- •acute or chronic diseases (except type 2 diabetes)
- •pregnancy or breast feeding
研究组 & 干预措施
Lifestyle intervention
Nutrition advices and formula diet
干预措施: Formula diet (Dietary Supplement)
结局指标
主要结局
degree of steatosis
时间窗: 12 weeks
degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation
次要结局
- fat mass(12 weeks and 52 weeks)
- Gamma-glutamyltransferase (GGT)(12 weeks and 52 weeks)
- insulin(12 weeks and 52 weeks)
- Glutamate Pyruvate Transaminase (GPT)(12 weeks and 52 weeks)
- degree of fibrosis(12 weeks and 52 weeks)
- degree of steatosis(52 weeks)
研究者
Stephan Martin
Principal investigator
West German Center of Diabetes and Health