Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease

Metabolic Syndrome Clinical Trial

— GC-NASH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553500
• Other study ID #: OPBG_GLUCO_2010
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2011
• Last updated: April 1, 2014
• Start date: June 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2012
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Insulin Resistance
• Liver Diseases
• Metabolic Syndrome
• Metabolic Syndrome X
• Non Alcoholic Fatty Liver Disease

Intervention

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

Behavioral:
• lifestyle intervention
hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity

Locations

Country	Name	City	State
Italy	Bambino Gesù Children's Hospital and Research Institute	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Bambino Gesù Hospital and Research Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in lipid profile	Evaluation of tryglicerides, total and LDL colesterol levels	6,12,18,24 months	No
Primary	Change from baseline in glycemic homeostasis	glycemic homeostesis will be evaluated through glycemia and insulinemia basal levels and after oral glucose tolerance test	6,12,18,24 months	No
Secondary	liver enzymes	evaluation of liver function test	6,12,18,24 months	Yes