Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catalysis SL
ClinicalTrials.gov Identifier:
NCT00820651
First received: January 9, 2009
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Nonalcoholic Steatohepatitis
Insulin Resistance
Dietary Supplement: Diamel
Other: Placebo and lifestyle counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 158
Study Start Date: November 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
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
Study First Received: January 9, 2009
Last Updated: April 25, 2012
Health Authority: Cuba: National Coordinating Center of Clinical Trials (CENCEC)

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
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 16, 2014