Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis

Liver Disease Clinical Trial

Official title:

Biochemical and Echosonographic Impacts Using Siliphos-Selenium-Methionine-Alpha Lipoic Acid + Metformin Versus Metformin in Patients With Fatty Liver and Steatohepatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650181
• Other study ID #: GAS-399-11/11/1
• Status: Completed
• Phase: Phase 4
• First received: July 11, 2012
• Last updated: August 18, 2014
• Start date: November 2011
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial Summary

Non-alcoholic steatohepatitis represents 10 - 15% total cases of hepatic cirrhosis. In the upcoming years, the economic burden of this disease will increase and will mean an important problem for our health system due to obesity epidemic.

There are several treatments for non-alcoholic steatohepatitis; however, none of them have overcome a healthy lifestyle including diet, exercise and some drugs related with insulin metabolism.

There after, using hepatoprotective drugs and antioxidants have been recommended as an eligible therapy to reduce the progression from fatty liver to steatohepatitis and cirrhosis. Being this approach not only an experimental item yet but also an unavoidable reality.

The purpose of this randomized controlled study is explore the effects of siliphos-selenium-methionine-alpha lipoic acid + metformin versus metformin in patients with fatty liver and non-alcoholic steatohepatitis about biochemical and echosonographic parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with Metabolic Syndrome according to ATP III Criteria

• Non smokers

• Without intake of vitamins or herbal medicine for at least one month

• Without uncontrolled glycemic levels

• Compatible ultrasound and/or histological report

Exclusion Criteria:

• Alcohol ingest > 50 gr weekly or chronic alcoholism

• Creatine serum > 2 mg/dL

• Potassium serum > 5.5 mEq/L

• Allergic to metformin or any components of the study

• Pregnancy

• Anomalies of blood coagulation or liver anatomic

• Patients with diseases and/or treatment that cause fatty liver or steatohepatitis

• Body weight change > 10% in the last 5 weeks

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fatty Liver
• Liver Disease
• Liver Diseases

Intervention

Drug:
• Metformin
Patients with Steatohepatitis treated with diet, exercise and metformin

Dietary Supplement:
• Siliphos+ Selenium - Methionine + Alpha Lipoic Acid
Patients with Steatohepatitis treated with diet, exercise, metformin and Siliphos (140mg) + Selenium (15 mcg) - Methionine (3mg) + Alpha Lipoic Acid (200mg), two tablets BID
• Siliphos+ Selenium - Methionine + Alpha Lipoic Acid
Patients with fatty liver treated with diet, exercise, metformin and Siliphos (140mg) + Selenium (15 mcg) - Methionine (3mg) + Alpha Lipoic Acid (200mg), two tablets BID

Drug:
• Metformin
Patients with fatty liver treated with diet, exercise and metformin

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
Primary	Impact on biochemical and echosonographic parameters	Identify and measure if patients with metabolic syndrome with NALFD under Siliphos (140mg) + Selenium (15mcg) - Methionine (3mg) + Alfa lipoic acid (200mg) treatment added to conventional therapy improves echosonographic pattern measure accord bright scale and biochemical parameters like LFT´s compared with conventional therapy alone (metformin + diet + exercise).	6 months	Yes
Secondary	Identify changes in anthropometric parameters	Identify and measure changes in anthropometrics parameters of metabolic syndrome like BMI, fasting glucose, lipid profile, arterial pressure, abdominal perimeter, waist index.	6 months	Yes