NCT00820651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 26, 2012

Status Verified

April 1, 2012

Enrollment Period

2.4 years

First QC Date

January 9, 2009

Last Update Submit

April 25, 2012

Conditions

Nonalcoholic SteatohepatitisInsulin Resistance

Keywords

Nonalcoholic steatohepatitisInsulinresistanceDiet and exerciseNutritional supplementNonalcoholic fatty liver diseaseLifestyle modifications

Outcome Measures

Primary Outcomes (1)

  • The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 52 weeks (end of the treatment) as compared with pre-treatment liver biopsy.

    52 weeks

Secondary Outcomes (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)

    52 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Other: Placebo and lifestyle counseling

Diamel

EXPERIMENTAL
Dietary Supplement: Diamel

Interventions

DiamelDIETARY_SUPPLEMENT

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

Also known as: Dietary supplement
Diamel
Placebo and lifestyle counselingOTHER

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)

Also known as: Placebo, Lifestyle modification
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Gastroenterology

Vedado, La Habana, 10400, Cuba

Location

Related Publications (1)

  • 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

    RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseInsulin ResistanceMotor Activity

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Eduardo Vilar Gomez, Ph.D

    National Institute of Gastroenterology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 12, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 26, 2012

Record last verified: 2012-04

Locations

CU(1)