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

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ClinicalTrials.gov Identifier: NCT01650181
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Liver Disease Drug: Metformin Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : November 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : June 2014

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Metformin
Patients treated with diet, exercise and metformin
 Drug: Metformin
Patients with Steatohepatitis treated with diet, exercise and metformin
Drug: 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 BID
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650181


Locations
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Principal Investigator: Aldo Torre Delgadillo, M.D., M. Sc. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: ALDO TORRE DELGADILLO, M.D. Science Master, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01650181     History of Changes
Other Study ID Numbers: GAS-399-11/11/1
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014

Keywords provided by ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
nafld, nash, fatty liver

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Metformin
Selenium
Thioctic Acid
Hypoglycemic Agents
Physiological Effects of Drugs
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements
Micronutrients
Growth Substances
Vitamin B Complex
Vitamins