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Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease (GC-NASH)

This study is currently recruiting participants.
Verified March 2012 by Bambino Gesù Hospital and Research Institute
Sponsor:
Information provided by (Responsible Party):
Valerio Nobili, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier:
NCT01553500
First received: October 3, 2011
Last updated: March 12, 2012
Last verified: March 2012
History of Changes
  Purpose

Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Insulin resistance and increased serum levels of free fatty acids (FFAs) are considered the main primary hits that lead to the excessive lipid accumulation in hepatocytes resulting in steatosis.

Has been reported that a diet rich in high-viscosity fiber improves glycemic control and lipid profile, suggesting a therapeutic potential role in the treatment of NAFLD.

Aim of this study is to evaluate the efficacy and tolerability of glucomannan in children affected by non alcoholic fatty liver disease.


Condition Intervention Phase
Metabolic Syndrome
Non Alcoholic Fatty Liver Disease
Insulin Resistance
 Dietary Supplement: glucomannan
Behavioral: lifestyle intervention
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Efficacy and Tolerability of Glucomannan on Children Affected by NAFLD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bambino Gesù Hospital and Research Institute:

Primary Outcome Measures:
  • Change from Baseline in lipid profile [ Time Frame: 6,12,18,24 months ] [ Designated as safety issue: No ]
    Evaluation of tryglicerides, total and LDL colesterol levels

  • Change from baseline in glycemic homeostasis [ Time Frame: 6,12,18,24 months ] [ Designated as safety issue: No ]
    glycemic homeostesis will be evaluated through glycemia and insulinemia basal levels and after oral glucose tolerance test


Secondary Outcome Measures:
  • liver enzymes [ Time Frame: 6,12,18,24 months ] [ Designated as safety issue: Yes ]
    evaluation of liver function test


Estimated Enrollment: 66
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: glucomannan Dietary Supplement: glucomannan
glucomannan is administered at dosage of 5g/day in form of biscuits (6 biscuits/day)
Placebo Comparator: placebo Behavioral: lifestyle intervention
hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • informed consent by parents or legal tutor
  • ALT levels <10 ULN
  • hyperechogenicity at liver ultrasound examination suggestive of fatty liver
  • INR < 1,3
  • Albumin > 3 g/dl
  • total bilirubin < 2,5 mg/dl
  • no previous gastrointestinal bleeding
  • no previous portosystemic encephalopathy
  • normal renal function
  • no HIV-HCV-HDV infection
  • normal cell blood count

Exclusion Criteria:

  • every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation
  • finding of active liver disease due to other causes
  • corticosteroids, immunosuppressive drugs or chemotherapy in the 2 months before of the study
  • alcohol consumption
  • use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
  • finding of actual or previous level of alpha-fetoprotein > 50 ng/ml
  • hepatocellular carcinoma
  • diabetes mellitus type I
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553500

Contacts
Contact: Valerio Nobili, MD 003968592863 nobili66@yahoo.it

Locations
Italy
Bambino Gesù Children's Hospital and Research Institute Recruiting
Rome, Italy, 00165
Contact         nobili66@yahho.it    
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
Investigators
Principal Investigator: Valerio Nobili, MD Bambino Gesù Children's Hospital
  More Information

No publications provided

Responsible Party: Valerio Nobili, Principal Investigator, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT01553500     History of Changes
Other Study ID Numbers: OPBG_GLUCO_2010
Study First Received: October 3, 2011
Last Updated: March 12, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Bambino Gesù Hospital and Research Institute:
NAFLD
insulin resistance
children

Additional relevant MeSH terms:
Fatty Liver
Insulin Resistance
Liver Diseases
Metabolic Syndrome X
Digestive System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
 Metabolic Diseases
(1-6)-alpha-glucomannan
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013