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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02051842
Enrollment
100
Registered
2014-01-31
Start date
2016-01-31
Completion date
2020-12-31
Last updated
2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD, Pre-diabetes

Keywords

NAFLD, oxidative stress, malondialdehyde

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.

Interventions

Sponsors

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Oxidative stressBaselineMalondialdehyde levels

Other

MeasureTime frameDescription
Oxidative stress3 month follow-upMalondialdehyde levels

Countries

Mexico

Contacts

Primary ContactAldo Torre, M.D., M.Sc.
detoal@yahoo.com54870900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026