Effect of Metadoxine on Oxidative Stress in Non-alcoholic Hepatic Steatosis

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status and phase: Unknown; Phase 4

Conditions: Pre-diabetes; NAFLD

Treatments: Drug: Metadoxine

Study type: Interventional

Funder types: Other

Identifiers

NCT02051842

GAS-1081-13/14-1

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female
• 18 to 65 years old
• Ultrasonographic diagnosis of NAFLD
• Prediabetes diagnosis

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Metadoxine

Experimental group

Description:

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

Treatment:

Drug: Metadoxine

Placebo tablet

Placebo Comparator group

Description:

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

Treatment:

Drug: Metadoxine