Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02051842
Recruitment Status : Unknown
Verified January 2019 by ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Recruitment status was:  Recruiting
First Posted : January 31, 2014
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
NAFLD Pre-diabetes Drug: Metadoxine Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Oxidative stress [ Time Frame: Baseline ]
    Malondialdehyde levels


Other Outcome Measures:
  1. Oxidative stress [ Time Frame: 3 month follow-up ]
    Malondialdehyde levels

  2. Oxidative stress [ Time Frame: 6 months follow-up ]
    Malondialdehyde levels


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051842


Contacts
Layout table for location contacts
Contact: Aldo Torre, M.D., M.Sc. 54870900 ext 2711 detoal@yahoo.com

Locations
Layout table for location information
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" Recruiting
Mexico City, Mexico, 14000
Contact: Aldo Torre, M.D, M.Sc.    54870900 ext 2711    detoal@yahoo.com   
Principal Investigator: Aldo Torre, MD MSci         
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Layout table for investigator information
Principal Investigator: Aldo Torre, MD MSci Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: January 31, 2014    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Keywords provided by ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
NAFLD
oxidative stress
malondialdehyde
Additional relevant MeSH terms:
Layout table for MeSH terms
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Metadoxine
Alcohol Deterrents