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

NCT02051842 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-01-31

No results posted yet for this study

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.

Conditions

  • NAFLD
  • Pre-diabetes

Interventions

DRUG

Metadoxine

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Aldo Torre, MD MSci · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-01-31
Completion
2020-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02051842 on ClinicalTrials.gov