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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01650181
First received: July 11, 2012
Last updated: August 18, 2014
Last verified: August 2014
History of Changes

July 11, 2012
August 18, 2014
November 2011
March 2014   (final data collection date for primary outcome measure)
Impact on biochemical and echosonographic parameters [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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).
Same as current
Complete list of historical versions of study NCT01650181 on ClinicalTrials.gov Archive Site
Identify changes in anthropometric parameters [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Identify and measure changes in anthropometrics parameters of metabolic syndrome like BMI, fasting glucose, lipid profile, arterial pressure, abdominal perimeter, waist index.
Same as current
Not Provided
Not Provided
 
Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis
Biochemical and Echosonographic Impacts Using Siliphos-Selenium-Methionine-Alpha Lipoic Acid + Metformin Versus Metformin in Patients With Fatty Liver and 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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Liver Disease
  • Drug: Metformin
    Patients with Steatohepatitis treated with diet, exercise and metformin
  • 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
  • Drug: Metformin
    Patients with fatty liver treated with diet, exercise and metformin
  • Active Comparator: Metformin
    Patients treated with diet, exercise and metformin
    Interventions:
    • Drug: Metformin
    • Drug: Metformin
  • Active Comparator: Suplement
    Patients treated with diet, exercise and metformin plus Siliphos (140mg) + Selenium (15mcg) -Methionine 3mg + Alpha Lipoic Acid (200mg).
    Interventions:
    • Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid
    • Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01650181
GAS-399-11/11/1
Yes
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Not Provided
Principal Investigator: Aldo Torre Delgadillo, M.D., M. Sc. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP