Clinical trial NCT00820651: Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis
Official title: Efficacy and Safety of Diamel, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized and Double Blind Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nonalcoholic Steatohepatitis
Insulin Resistance
Keywords: Nonalcoholic steatohepatitis
Insulinresistance
Diet and exercise
Nutritional supplement
Nonalcoholic fatty liver disease
Lifestyle modifications
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 52 weeks (end of the treatment) as compared with pre-treatment liver biopsy.
timeFrame: 52 weeks
Secondary outcomes:
measure: 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)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Vedado
country: Cuba
facility: National Institute of Gastroenterology
state: Havana
Study officials:
affiliation: National Institute of Gastroenterology
name: Eduardo Vilar Gomez, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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