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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.


Clinical Trial Description

n/a


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


NCT number NCT01553500
Study type Interventional
Source Bambino Gesù Hospital and Research Institute
Contact
Status Completed
Phase Phase 2
Start date June 2011
Completion date December 2013

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