Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis
Overview[ - collapse ][ - ]
| 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 | Liver Disease |
| Intervention | Drug: Metformin Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid Drug: Metformin |
| Phase | Phase 4 |
| Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| Responsible Party | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| ClinicalTrials.gov Identifier | NCT01650181 |
| First Received | July 11, 2012 |
| Last Updated | December 16, 2013 |
| Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 11, 2012 |
|---|---|
| Last Updated Date | December 16, 2013 |
| Start Date | November 2011 |
| Estimated Primary Completion Date | December 2014 |
| Current 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). |
| Current 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. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis |
|---|---|
| Official Title | Biochemical and Echosonographic Impacts Using Siliphos-Selenium-Methionine-Alpha Lipoic Acid + Metformin Versus Metformin in Patients With Fatty Liver and Steatohepatitis |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care |
| Condition | Liver Disease |
| Intervention | 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 |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 40 |
| Estimated Completion Date | December 2014 |
| Estimated Primary Completion Date | March 2014 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Aldo Torre Delgadillo, M.D., M.Sc. 525554870900 detoal@yahoo.com |
| Location Countries | Mexico |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01650181 |
|---|---|
| Other Study ID Numbers | GAS-399-11/11/1 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| Study Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Aldo Torre Delgadillo, M.D., M. Sc. Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán |
| Verification Date | December 2013 |
Locations[ + expand ][ + ]
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán | Mexico City, Mexico, 14000 Contact: Aldo Torre Delgadillo, M.D., M.Sc. | 5255548709002714 | detoal@yahoo.comRecruiting |
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