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

Primary Purpose

Metabolic Syndrome, Non Alcoholic Fatty Liver Disease, Insulin Resistance

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

glucomannan

lifestyle intervention

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring NAFLD, insulin resistance, children

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Bambino Gesù Children's Hospital and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

glucomannan

placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in lipid profile

Evaluation of tryglicerides, total and LDL colesterol levels

Change from baseline in glycemic homeostasis

glycemic homeostesis will be evaluated through glycemia and insulinemia basal levels and after oral glucose tolerance test

Secondary Outcome Measures

liver enzymes

evaluation of liver function test

Full Information

NCT ID

NCT01553500

First Posted

October 3, 2011

Last Updated

April 1, 2014

Sponsor

Bambino Gesù Hospital and Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01553500

Brief Title

Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease

Acronym

GC-NASH

Official Title

Study of the Efficacy and Tolerability of Glucomannan on Children Affected by NAFLD

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bambino Gesù Hospital and Research Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome, Non Alcoholic Fatty Liver Disease, Insulin Resistance

Keywords

NAFLD, insulin resistance, children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

glucomannan

Arm Type

Experimental

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

glucomannan

Intervention Description

glucomannan is administered at dosage of 5g/day in form of biscuits (6 biscuits/day)

Intervention Type

Behavioral

Intervention Name(s)

lifestyle intervention

Intervention Description

hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity

Primary Outcome Measure Information:

Title

Change from Baseline in lipid profile

Description

Evaluation of tryglicerides, total and LDL colesterol levels

Time Frame

6,12,18,24 months

Title

Change from baseline in glycemic homeostasis

Description

glycemic homeostesis will be evaluated through glycemia and insulinemia basal levels and after oral glucose tolerance test

Time Frame

6,12,18,24 months

Secondary Outcome Measure Information:

Title

liver enzymes

Description

evaluation of liver function test

Time Frame

6,12,18,24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Valerio Nobili, MD

Organizational Affiliation

Bambino Gesù Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bambino Gesù Children's Hospital and Research Institute

City

Rome

ZIP/Postal Code

00165

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease

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