Trial record 13 of 176 for:    "Visceral steatosis"

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
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 April 17, 2014