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

NCT02051842 | Unknown Phase 4

• 1 other identifier: GAS-1081-13/14-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD; Pre-diabetes

Keywords

NAFLD; oxidative stress; malondialdehyde

Outcome Measures

Primary Outcomes (1)

• Oxidative stress

  Malondialdehyde levels

  Baseline

Other Outcomes (2)

• Oxidative stress

  3 month follow-up

• Oxidative stress

  6 months follow-up

Study Arms (2)

Metadoxine

EXPERIMENTAL

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

Placebo tablet

PLACEBO COMPARATOR

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

Interventions

Metadoxine DRUG

Also known as: Metadoxil, Abrixone

Metadoxine; Placebo tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female
• to 65 years old
• Ultrasonographic diagnosis of NAFLD
• Prediabetes diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Mexico City, 14000, Mexico

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Glucose Intolerance

Interventions

metadoxine

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Aldo Torre, MD MSci

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aldo Torre, M.D., M.Sc.

CONTACT

54870900; detoal@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: January 31, 2014
• Study Start: January 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

ME (1)