Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

Phase 3

Completed

• Conditions: Insulin Resistance; Nonalcoholic Steatohepatitis
• Interventions: Other: Placebo and lifestyle counseling; Dietary Supplement: Diamel

• Registration Number: NCT00820651
• Lead Sponsor: Catalysis SL

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Study Start: 2009-11
• Status Verified: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2012-04-25
• Last Update Posted: 2012-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo and lifestyle counseling	-
Diamel	Diamel	-

Primary Outcome Measures

Name	Time	Method
The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 52 weeks (end of the treatment) as compared with pre-treatment liver biopsy.	52 weeks

Secondary Outcome Measures

Name	Time	Method
Insulinresistance levels (HOMA-IR) at 52 weeks (end of the treatment), Aminotransferase levels at 52 weeks (end of the treatment), Body weight, Body Mass Index and waist circumference at 52 weeks (end of the treatment)	52 weeks

Trial Locations

Locations (1)

National Institute of Gastroenterology; 🇨🇺 Vedado, Havana, Cuba