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

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ClinicalTrials.gov Identifier: NCT01553500
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Valerio Nobili, Bambino Gesù Hospital and Research Institute

Brief Summary:

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 or disease Intervention/treatment Phase
Metabolic Syndrome Non Alcoholic Fatty Liver Disease Insulin Resistance Dietary Supplement: glucomannan Behavioral: lifestyle intervention Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Efficacy and Tolerability of Glucomannan on Children Affected by NAFLD
Study Start Date : June 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change from Baseline in lipid profile [ Time Frame: 6,12,18,24 months ]
    Evaluation of tryglicerides, total and LDL colesterol levels

  2. Change from baseline in glycemic homeostasis [ Time Frame: 6,12,18,24 months ]
    glycemic homeostesis will be evaluated through glycemia and insulinemia basal levels and after oral glucose tolerance test


Secondary Outcome Measures :
  1. liver enzymes [ Time Frame: 6,12,18,24 months ]
    evaluation of liver function test



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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553500


Locations
Italy
Bambino Gesù Children's Hospital and Research Institute
Rome, Italy, 00165
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
Investigators
Principal Investigator: Valerio Nobili, MD Bambino Gesù Children's Hospital

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
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: March 2012

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

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