Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Insulin Resistance; Nonalcoholic Steatohepatitis

Treatments: Dietary Supplement: Diamel; Other: Placebo and lifestyle counseling

Study type: Interventional

Funder types: Industry

Identifiers

NCT00820651

DIAMEL_NASH-09

Details and patient eligibility

About

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 activity and fibrosis), insulin resistance, aminotransferase levels and anthropometric measures in comparison with a placebo-controlled group with hypocaloric diet and exercise during 52 weeks of treatment in patients with nonalcoholic steatohepatitis.

Enrollment: 158 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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158 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Other: Placebo and lifestyle counseling

Diamel

Experimental group

Treatment:

Dietary Supplement: Diamel