Biochemical and Echosonographic Impacts Using Siliphos-Selenium-Methionine-Alpha Lipoic Acid + Metformin Versus Metformin in Patients With Fatty Liver and Steatohepatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Impact on biochemical and echosonographic parameters
研究概览
简要总结
Non-alcoholic steatohepatitis represents 10 - 15% total cases of hepatic cirrhosis. In the upcoming years, the economic burden of this disease will increase and will mean an important problem for our health system due to obesity epidemic.
There are several treatments for non-alcoholic steatohepatitis; however, none of them have overcome a healthy lifestyle including diet, exercise and some drugs related with insulin metabolism.
There after, using hepatoprotective drugs and antioxidants have been recommended as an eligible therapy to reduce the progression from fatty liver to steatohepatitis and cirrhosis. Being this approach not only an experimental item yet but also an unavoidable reality.
The purpose of this randomized controlled study is explore the effects of siliphos-selenium-methionine-alpha lipoic acid + metformin versus metformin in patients with fatty liver and non-alcoholic steatohepatitis about biochemical and echosonographic parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Metabolic Syndrome according to ATP III Criteria
- •Non smokers
- •Without intake of vitamins or herbal medicine for at least one month
- •Without uncontrolled glycemic levels
- •Compatible ultrasound and/or histological report
排除标准
- •Alcohol ingest > 50 gr weekly or chronic alcoholism
- •Creatine serum > 2 mg/dL
- •Potassium serum > 5.5 mEq/L
- •Allergic to metformin or any components of the study
- •Pregnancy
- •Anomalies of blood coagulation or liver anatomic
- •Patients with diseases and/or treatment that cause fatty liver or steatohepatitis
- •Body weight change > 10% in the last 5 weeks
研究组 & 干预措施
Metformin
Patients treated with diet, exercise and metformin
干预措施: Metformin (Drug)
Suplement
Patients treated with diet, exercise and metformin plus Siliphos (140mg) + Selenium (15mcg) -Methionine 3mg + Alpha Lipoic Acid (200mg).
干预措施: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid (Dietary Supplement)
结局指标
主要结局
Impact on biochemical and echosonographic parameters
时间窗: 6 months
Identify and measure if patients with metabolic syndrome with NALFD under Siliphos (140mg) + Selenium (15mcg) - Methionine (3mg) + Alfa lipoic acid (200mg) treatment added to conventional therapy improves echosonographic pattern measure accord bright scale and biochemical parameters like LFT´s compared with conventional therapy alone (metformin + diet + exercise).
次要结局
- Identify changes in anthropometric parameters(6 months)
研究者
ALDO TORRE DELGADILLO
M.D. Science Master
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran