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

NCT01650181 | Completed Phase 4 DMC

• 1 other identifier: GAS-399-11/11/1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Disease

Keywords

nafld, nash, fatty liver

Outcome Measures

Primary Outcomes (1)

• Impact on biochemical and echosonographic parameters

  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).

  6 months

Secondary Outcomes (1)

• Identify changes in anthropometric parameters

  6 months

Study Arms (2)

Metformin

ACTIVE COMPARATOR

Patients treated with diet, exercise and metformin

Drug: Metformin

Suplement

ACTIVE COMPARATOR

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

Interventions

Metformin DRUG

Patients with Steatohepatitis treated with diet, exercise and metformin

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

Suplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico City, 14000, Mexico

Location

MeSH Terms

Conditions

Liver Diseases; Non-alcoholic Fatty Liver Disease; Fatty Liver

Interventions

Metformin; Thioctic Acid

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Carboxylic Acids; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Aldo Torre Delgadillo, M.D., M. Sc.

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Science Master

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 26, 2012
• Study Start: November 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

ME (1)