Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

Overview

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.

Full Title of Study: “Efficacy and Safety of Diamel, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized and Double Blind Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2012

Interventions

  • Dietary Supplement: Diamel
    • Diamel, a nutritional supplement, 2 oral pills (660 mg), every 8 hours, daily, during 52 weeks
  • 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)

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
  • Experimental: Diamel

Clinical Trial Outcome Measures

Primary 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

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Catalysis SL
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eduardo Vilar Gomez, Ph.D, Principal Investigator, National Institute of Gastroenterology

Citations Reporting on 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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