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

Overview

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.

Full Title of Study: “Effect of Metadoxine on Oxidative Stress in Non-alcoholic Fatty Liver Disease Prediabetic Mexican Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2020

Interventions

  • Drug: Metadoxine

Arms, Groups and Cohorts

  • Experimental: 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
  • Placebo Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • Oxidative stress
    • Time Frame: Baseline
    • Malondialdehyde levels

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Provider of Information About this Clinical Study
    • Principal Investigator: ALDO TORRE DELGADILLO, Principal investigator – Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Overall Official(s)
    • Aldo Torre, MD MSci, Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Overall Contact(s)
    • Aldo Torre, M.D., M.Sc., 54870900, detoal@yahoo.com

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