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NCT Number: NCT01650181

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.

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Key information

Conditions

Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14000, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

Patients with Steatohepatitis treated with diet, exercise and metformin

Siliphos+ Selenium - Methionine + Alpha Lipoic Acid

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 26, 2012
Registry last updated
Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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