Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

Insulin Resistance Clinical Trial

Official title:

Efficacy and Safety of Diamel, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized and Double Blind Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820651
• Other study ID #: DIAMEL_NASH-09
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2009
• Last updated: April 25, 2012
• Start date: November 2009
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: National Coordinating Center of Clinical Trials (CENCEC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 a-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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Insulin Resistance
• Nonalcoholic Steatohepatitis

Intervention

Dietary Supplement:
• Diamel
Diamel, a nutritional supplement, 2 oral pills (660 mg), every 8 hours, daily, during 52 weeks

Other:
• Placebo and lifestyle counseling
Hypocaloric diet of 1620 kcal daily (The dietary pattern will be distributed in carbohydrates 64%, fat 22% with <10% of saturated fatty acids and protein 14%, and exercise)

Locations

Country	Name	City	State
Cuba	National Institute of Gastroenterology	Vedado	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

References & Publications (1)

Hernandez Yero JA, Vargas Gonzalez D. Utilidad de Diamel en pacientes con diabetes mellitus tipo 2 en tratamiento combinado con glibenclamida. Avances en Diabetología 23(1):284-290, 2007

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No