Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease

Phase 2

Completed

• Conditions: Insulin Resistance; Metabolic Syndrome; Non Alcoholic Fatty Liver Disease

• Registration Number: NCT01553500
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-10-03
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-14
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Last Update Submitted: 2014-04-01
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in lipid profile	6,12,18,24 months	Evaluation of tryglicerides, total and LDL colesterol levels
Change from baseline in glycemic homeostasis	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

Name	Time	Method
liver enzymes	6,12,18,24 months	evaluation of liver function test

Trial Locations

Locations (1)

Bambino Gesù Children's Hospital and Research Institute; 🇮🇹 Rome, Italy