- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01553500
Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease (GC-NASH)
Study of the Efficacy and Tolerability of Glucomannan on Children Affected by NAFLD
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Rome, Italy, 00165
- Bambino Gesù Children's Hospital and Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity
|
Experimental: glucomannan
|
glucomannan is administered at dosage of 5g/day in form of biscuits (6 biscuits/day)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in lipid profile
Time Frame: 6,12,18,24 months
|
Evaluation of tryglicerides, total and LDL colesterol levels
|
6,12,18,24 months
|
Change from baseline in glycemic homeostasis
Time Frame: 6,12,18,24 months
|
glycemic homeostesis will be evaluated through glycemia and insulinemia basal levels and after oral glucose tolerance test
|
6,12,18,24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
liver enzymes
Time Frame: 6,12,18,24 months
|
evaluation of liver function test
|
6,12,18,24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Valerio Nobili, MD, Bambino Gesù Children's Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPBG_GLUCO_2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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