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

Study Overview
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Brief Summary
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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.

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

Conditions
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NAFLD, Pre-diabetes

Intervention / Treatment
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* Drug: Metadoxine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metadoxine<br>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 | Drug: Metadoxine<br> <br> * Other names: Abrixone;|
| Placebo Comparator: Placebo tablet<br>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 | Drug: Metadoxine<br> <br> * Other names: Abrixone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress | Malondialdehyde levels | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAFLD, oxidative stress, malondialdehyde