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

NAFLD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02051842
• Other study ID #: GAS-1081-13/14-1
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: January 2019
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: Aldo Torre, M.D., M.Sc.
• Phone: 54870900
• Email: detoal[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Pre-diabetes
• Prediabetic State

Intervention

Drug:
• Metadoxine

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oxidative stress	Malondialdehyde levels	3 month follow-up
Other	Oxidative stress	Malondialdehyde levels	6 months follow-up
Primary	Oxidative stress	Malondialdehyde levels	Baseline