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Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

Primary Purpose

Nonalcoholic Steatohepatitis, Insulin Resistance

Status
Completed
Phase
Phase 3
Locations
Cuba
Study Type
Interventional
Intervention
Diamel
Placebo and lifestyle counseling
Sponsored by
Catalysis SL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis focused on measuring Nonalcoholic steatohepatitis, Insulinresistance, Diet and exercise, Nutritional supplement, Nonalcoholic fatty liver disease, Lifestyle modifications

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute of Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Diamel

Arm Description

Outcomes

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.

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)

Full Information

First Posted
January 9, 2009
Last Updated
April 25, 2012
Sponsor
Catalysis SL
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1. Study Identification

Unique Protocol Identification Number
NCT00820651
Brief Title
Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis
Official Title
Efficacy and Safety of Diamel, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized and Double Blind Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalysis SL

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis, Insulin Resistance
Keywords
Nonalcoholic steatohepatitis, Insulinresistance, Diet and exercise, Nutritional supplement, Nonalcoholic fatty liver disease, Lifestyle modifications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Diamel
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Diamel
Other Intervention Name(s)
Dietary supplement
Intervention Description
Diamel, a nutritional supplement, 2 oral pills (660 mg), every 8 hours, daily, during 52 weeks
Intervention Type
Other
Intervention Name(s)
Placebo and lifestyle counseling
Other Intervention Name(s)
Placebo, Lifestyle modification
Intervention Description
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)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Vilar Gomez, Ph.D
Organizational Affiliation
National Institute of Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Gastroenterology
City
Vedado
State/Province
Havana
ZIP/Postal Code
10400
Country
Cuba

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
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Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

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