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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-12-31

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.

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Detailed Description

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Conditions

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NAFLD Pre-diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Metadoxine

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Metadoxine

Intervention Type DRUG

Interventions

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Metadoxine

Intervention Type DRUG

Other Intervention Names

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Metadoxil Abrixone

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No