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Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00820651
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : April 26, 2012
Information provided by (Responsible Party):
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.

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

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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

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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

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 identifier (NCT number): NCT00820651

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National Institute of Gastroenterology
Vedado, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
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Principal Investigator: Eduardo Vilar Gomez, Ph.D National Institute of Gastroenterology
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

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Responsible Party: Catalysis SL Identifier: NCT00820651    
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
Diet and exercise
Nutritional supplement
Nonalcoholic fatty liver disease
Lifestyle modifications
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases