NCT02366052已完成2 期
Nutritional Counseling Versus Nutritional Supplements for the Treatment of NASH - a Randomized Prospective, Open Label Pilot Study (Nuces NASH)
Johannes Gutenberg University Mainz4 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2015年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Reduction of the M30 antigen in the serum
研究概览
简要总结
The main aim of the study is to determine if an oral supplementation of the LCS has a beneficial effect by itself or even enhances the beneficial effects of a moderate life-style intervention on the progression of NAFLD in humans.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Elevated M30 antigen levels (cutoff: >200 - 800 U/L) at screening AND hepatic steatosis on ultrasound
- •OR histologically confirmed NASH
- •- Age 18 to 75 years
排除标准
- •Alcohol intake of more than 30 g/d (men) or 20 g/d (women)
- •Treatment with ursodeoxycholic acid (UDCA), Vitamin E or other investigational NASH drugs 3 months prior to randomization
- •Treatment with medications or substances that may induce secondary NASH (e.g., tamoxifen, corticosteroids, amiodarone, methotrexate) or ameliorate NASH (TNF-antagonists)
- •Treatment with phenprocoumon or warfarin
- •Hepatocellular carcinoma or non-hepatic malignancy
- •Decompensated cirrhosis (Child B,C) or a history of decompensation
- •Liver disease unrelated to NASH, including chronic viral hepatitis B/D or C, autoimmune hepatitis, Wilson's disease or clinical manifest iron overload
- •Bariatric surgery within the last 5 years
- •BMI <18,5 kg/m2 or BMI >45 kg/m2
- •Liver transplantation
- •Heart failure (New York Heart Association Class II - IV)
- •Myocardial infarction, instable coronary artery disease , coronary artery intervention or stroke in the previous 6 months
- •Instable chronic obstructive pulmonary disease, chronic inflammatory bowel disease or rheumatoid arthritis.
- •Instable renal insufficiency (changes in serum creatinin > 50% in the last 3 month) or terminal renal insufficiency requiring dialysis
- •Uncontrolled hypertension (blood pressure > 180/90 despite therapy)
- •Uncontrolled diabetes mellitus defined by hemoglobin A1c > 9
- •Food allergies requiring strictly dietary adherence
- •Pregnant or nursing women
- •Chronic pancreatitis or history of recurring acute pancreatitis
结局指标
主要结局
Reduction of the M30 antigen in the serum
时间窗: 12 and 24 weeks
Reduction of the M30 antigen as a validated measure of the degree of hepatocellular inflammation and injury
次要结局
- Saftey and tolerability(12 and 24 weeks)
- Change in indicators of hepatocellular injury and fibrosis(12 and 24 weeks)
- Change in metabolic risk factors(12 and 24 weeks)
研究者
Priv.-Doz. Dr. J. Schattenberg
Attending Physician
Johannes Gutenberg University Mainz
研究点 (4)
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