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临床试验/NCT02051842
NCT02051842Unknown4 期

Effect of Metadoxine on Oxidative Stress in Non-alcoholic Fatty Liver Disease Prediabetic Mexican Patients

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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 Comparator

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

发起方
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
申办方类型
Other
责任方
Principal Investigator
主要研究者

ALDO TORRE DELGADILLO

Principal investigator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

研究点 (1)

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