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

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:

Drug Information available for: Racemethionine Methionine Metformin Thioctic acid Metformin hydrochloride Lipoic acid Selenomethionine

Genetic and Rare Diseases Information Center resources: Visceral Steatosis

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.


Enrollment:	50
Study Start Date:	November 2011
Study Completion Date:	June 2014
Primary Completion Date:	March 2014 (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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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:	August 18, 2014
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:


Metformin Selenium Thioctic Acid Antioxidants Growth Substances Hypoglycemic Agents Micronutrients	Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protective Agents Trace Elements Vitamin B Complex Vitamins

ClinicalTrials.gov processed this record on March 03, 2015