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

This study is currently recruiting participants.
Verified July 2012 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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: July 23, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Liver Disease
 Drug: Metformin
Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650181

Contacts
Contact: Aldo Torre Delgadillo, M.D., M.Sc. 525554870900 ext 2714 detoal@yahoo.com

Locations
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Recruiting
Mexico City, Mexico, 14000
Contact: Aldo Torre Delgadillo, M.D., M.Sc.     525554870900 ext 2714     detoal@yahoo.com    
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 Médicas y Nutrición Salvador Zubirán
  More Information

No publications provided

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
Study First Received: July 11, 2012
Last Updated: July 23, 2012
Health Authority: Mexico: Secretaria de Salud

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

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

ClinicalTrials.gov processed this record on May 22, 2013