Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis
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.
|Liver Disease||Drug: Metformin Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Biochemical and Echosonographic Impacts Using Siliphos-Selenium-Methionine-Alpha Lipoic Acid + Metformin Versus Metformin in Patients With Fatty Liver and Steatohepatitis|
- Impact on biochemical and echosonographic parameters [ Time Frame: 6 months ]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).
- Identify changes in anthropometric parameters [ Time Frame: 6 months ]Identify and measure changes in anthropometrics parameters of metabolic syndrome like BMI, fasting glucose, lipid profile, arterial pressure, abdominal perimeter, waist index.
|Study Start Date:||November 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Metformin
Patients treated with diet, exercise and metformin
Patients with Steatohepatitis treated with diet, exercise and metforminDrug: Metformin
Patients with fatty liver treated with diet, exercise and metformin
Active Comparator: Suplement
Patients treated with diet, exercise and metformin plus Siliphos (140mg) + Selenium (15mcg) -Methionine 3mg + Alpha Lipoic Acid (200mg).
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 BIDDietary Supplement: 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650181
|Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán|
|Mexico City, Mexico, 14000|
|Principal Investigator:||Aldo Torre Delgadillo, M.D., M. Sc.||Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran|