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

Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)
Overall Status
Unknown status
CT.gov ID
NCT02051842
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
59
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Metadoxine on Oxidative Stress in Non-alcoholic Fatty Liver Disease Prediabetic Mexican Patients
Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
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

Drug: Metadoxine
Other Names:
  • Metadoxil
  • Abrixone

    		•
    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

    Drug: Metadoxine
    Other Names:
  • Metadoxil
  • Abrixone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Oxidative stress [Baseline]

      Malondialdehyde levels

    Other Outcome Measures

    1. Oxidative stress [3 month follow-up]

      Malondialdehyde levels

    2. Oxidative stress [6 months follow-up]

      Malondialdehyde levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" Mexico City Mexico 14000

    Sponsors and Collaborators

    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Investigators

    • Principal Investigator: Aldo Torre, MD MSci, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ALDO TORRE DELGADILLO, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    ClinicalTrials.gov Identifier:
    NCT02051842
    Other Study ID Numbers:
    • GAS-1081-13/14-1
    First Posted:
    Jan 31, 2014
    Last Update Posted:
    Jan 31, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by ALDO TORRE DELGADILLO, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    NAFLD
    oxidative stress
    malondialdehyde
    Additional relevant MeSH terms:
    Prediabetic State
    Metadoxine

    Study Results

    No Results Posted as of Jan 31, 2019