Effect of Metadoxine on Oxidative Stress in Non-alcoholic Fatty Liver Disease Prediabetic Mexican Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Oxidative stress
研究概览
简要总结
Oxidative stress is produced by imbalance between reactive oxygen species and antioxidant systems. This state is frequently associated with chronic diseases like obesity, insulin resistance, metabolic syndrome and hepatic steatosis. In the liver, the oxidative stress may trigger the progression of fatty liver disease, from triglyceride accumulation to inflammation, cirrhosis and hepatocellular carcinoma. Thus, the attenuation of oxidative stress, could be an important therapeutic target to lessen the severity of the disease. Until now, there is not a medical treatment to cure non-alcoholic fatty liver disease, but therapies aimed at reducing oxidative stress have been proposed. Metadoxine, an ionic complex of pyridoxine-pyrrolidone molecule, acts as a synthetic antioxidant, forming traps that can reduce free radicals; likewise, metadoxine has a proven capacity to reduce fat liver in alcoholic hepatitis. Finally, in fact that alcoholic and non-alcoholic liver diseases share molecular mechanisms in the generation of oxidative stress, the investigators propose metadoxine as a posssible modifier of the oxidative stress in non-alcoholic liver disease, prediabetic patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Male and female
- •18 to 65 years old
- •Ultrasonographic diagnosis of NAFLD
- •Prediabetes diagnosis
排除标准
- •Alcoholism
- •Hepatitis C or B Virus Infection
- •Pregnancy
- •Autoimmune hepatitis
- •Metformin or metadoxine allergy
- •Parenteral nutrition in the last month
- •Weigh loss greater than 10% in the last month
- •Taking vitamin supplements in the last month
研究组 & 干预措施
Metadoxine
Metadoxine 500 mg tablets by mouth every 12 hours for 6 months and metformin 500 mg tablets by mouth every 8 hours for 6 months
干预措施: Metadoxine (Drug)
Placebo tablet
Placebo tablet (for Metadoxine) by mouth every 12 hours for 6 months and metformin 500 mg tablets by mouth every 8 hours for 6 months
干预措施: Metadoxine (Drug)
结局指标
主要结局
Oxidative stress
时间窗: Baseline
Malondialdehyde levels
次要结局
未报告次要终点
研究者
ALDO TORRE DELGADILLO
Principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
