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Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

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ClinicalTrials.gov Identifier: NCT00820651
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : April 26, 2012
Sponsor:
Information provided by (Responsible Party):
Catalysis SL

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Insulin Resistance Dietary Supplement: Diamel Other: Placebo and lifestyle counseling Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Diamel, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized and Double Blind Controlled Study
Study Start Date : November 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo 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)
Other Names:
  • Placebo
  • Lifestyle modification
Experimental: Diamel Dietary Supplement: Diamel
Diamel, a nutritional supplement, 2 oral pills (660 mg), every 8 hours, daily, during 52 weeks
Other Name: Dietary supplement


Outcome Measures
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Primary Outcome Measures :
  1. The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 52 weeks (end of the treatment) as compared with pre-treatment liver biopsy. [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. 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) [ Time Frame: 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820651


Locations
Cuba
National Institute of Gastroenterology
Vedado, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Eduardo Vilar Gomez, Ph.D National Institute of Gastroenterology
More Information
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Additional Information:
Paper published in full text version  This link exits the ClinicalTrials.gov site

Publications of Results:
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

Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT00820651     History of Changes
Other Study ID Numbers: DIAMEL_NASH-09
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: April 26, 2012
Last Verified: April 2012

Keywords provided by Catalysis SL:
Nonalcoholic steatohepatitis
Insulinresistance
Diet and exercise
 Nutritional supplement
Nonalcoholic fatty liver disease
Lifestyle modifications

Additional relevant MeSH terms:
Insulin Resistance
Fatty Liver
Non-alcoholic Fatty Liver Disease
Hyperinsulinism
 Glucose Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases