Status:
COMPLETED
Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis
Lead Sponsor:
Catalysis SL
Conditions:
Nonalcoholic Steatohepatitis
Insulin Resistance
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate whether the addition of Diamel, a nutritional supplement, to hypocaloric diet and exercise could improve the histological results (steatosis, necro-inflammatory...
Eligibility Criteria
Inclusion
- Histological diagnosis of steatohepatitis (minimal histological criteria for steatohepatitis include steatosis involving at least 5% of hepatocytes, lobular inflammation, and/or fibrosis)
- Age between 18 and 70 years
- Ability to provide informed consent
- Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)
Exclusion
- Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and α-1 antitrypsin deficiency)
- Pregnancy or lactation
- Decompensated cirrhosis
- Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery
- Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil
- Fasting glucose levels greater than 250 mg per deciliter (13.3 mmolm per liter)
- Contraindication to liver biopsy
- Refusal to participate in the study
- Concomitant disease with reduced life expectancy
- Severe psychiatric conditions
- Drug dependence
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00820651
Start Date
November 1 2009
End Date
April 1 2012
Last Update
April 26 2012
Active Locations (1)
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1
National Institute of Gastroenterology
Vedado, La Habana, Cuba, 10400