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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Metformin

Patients treated with diet, exercise and metformin

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Patients with Steatohepatitis treated with diet, exercise and metformin

Metformin

Intervention Type DRUG

Patients with fatty liver treated with diet, exercise and metformin

Suplement

Patients treated with diet, exercise and metformin plus Siliphos (140mg) + Selenium (15mcg) -Methionine 3mg + Alpha Lipoic Acid (200mg).

Group Type ACTIVE_COMPARATOR

Siliphos+ Selenium - Methionine + Alpha Lipoic Acid

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Metformin

Patients with Steatohepatitis treated with diet, exercise and metformin

Intervention Type DRUG

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

Intervention Type DIETARY_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

Intervention Type DIETARY_SUPPLEMENT

Metformin

Patients with fatty liver treated with diet, exercise and metformin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No