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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Liver Disease

Intervention / Treatment
-----------------
* Drug: Metformin
* Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid
* Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin<br>Patients treated with diet, exercise and metformin | Drug: Metformin<br>* Patients with Steatohepatitis treated with diet, exercise and metformin<br>Drug: Metformin<br>* Patients with fatty liver treated with diet, exercise and metformin<br>|
| Active Comparator: Suplement<br>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<br>* Patients with Steatohepatitis treated with diet, exercise, metformin and Siliphos (140mg) + Selenium (15 mcg) - Methionine (3mg) + Alpha Lipoic Acid (200mg), two tablets BID<br>Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid<br>* Patients with fatty liver treated with diet, exercise, metformin and Siliphos (140mg) + Selenium (15 mcg) - Methionine (3mg) + Alpha Lipoic Acid (200mg), two tablets BID<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nafld, nash, fatty liver