Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease

NCT01553500 | Completed Phase 2

• 1 other identifier: OPBG_GLUCO_2010
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Non Alcoholic Fatty Liver Disease; Insulin Resistance

Keywords

NAFLD; insulin resistance; children

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in lipid profile

  Evaluation of tryglicerides, total and LDL colesterol levels

  6,12,18,24 months

• 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

Secondary Outcomes (1)

• liver enzymes

  6,12,18,24 months

Study Arms (2)

glucomannan

EXPERIMENTAL

Dietary Supplement: glucomannan

placebo

PLACEBO COMPARATOR

Behavioral: lifestyle intervention

Interventions

glucomannan DIETARY_SUPPLEMENT

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

glucomannan

lifestyle intervention BEHAVIORAL

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

placebo

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead

Study Sites (1)

Bambino Gesù Children's Hospital and Research Institute

Rome, 00165, Italy

Location

MeSH Terms

Conditions

Metabolic Syndrome; Non-alcoholic Fatty Liver Disease; Insulin Resistance

Interventions

(1-6)-alpha-glucomannan

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Valerio Nobili, MD

  Bambino Gesù Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2011
• First Posted: March 14, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 2, 2014

Record last verified: 2012-03

Locations

IT (1)