Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT01553500
Status:
COMPLETED
Last Update Posted:
2014-04-02
First Post:
2011-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C022901', 'term': '(1-6)-alpha-glucomannan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-01', 'studyFirstSubmitDate': '2011-10-03', 'studyFirstSubmitQcDate': '2012-03-12', 'lastUpdatePostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in lipid profile', 'timeFrame': '6,12,18,24 months', 'description': 'Evaluation of tryglicerides, total and LDL colesterol levels'}, {'measure': 'Change from baseline in glycemic homeostasis', 'timeFrame': '6,12,18,24 months', 'description': 'glycemic homeostesis will be evaluated through glycemia and insulinemia basal levels and after oral glucose tolerance test'}], 'secondaryOutcomes': [{'measure': 'liver enzymes', 'timeFrame': '6,12,18,24 months', 'description': 'evaluation of liver function test'}]}, 'conditionsModule': {'keywords': ['NAFLD', 'insulin resistance', 'children'], 'conditions': ['Metabolic Syndrome', 'Non Alcoholic Fatty Liver Disease', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': '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.\n\nHas 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.\n\nAim of this study is to evaluate the efficacy and tolerability of glucomannan in children affected by non alcoholic fatty liver disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* informed consent by parents or legal tutor\n* ALT levels \\<10 ULN\n* hyperechogenicity at liver ultrasound examination suggestive of fatty liver\n* INR \\< 1,3\n* Albumin \\> 3 g/dl\n* total bilirubin \\< 2,5 mg/dl\n* no previous gastrointestinal bleeding\n* no previous portosystemic encephalopathy\n* normal renal function\n* no HIV-HCV-HDV infection\n* normal cell blood count\n\nExclusion Criteria:\n\n* every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation\n* finding of active liver disease due to other causes\n* corticosteroids, immunosuppressive drugs or chemotherapy in the 2 months before of the study\n* alcohol consumption\n* use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism\n* finding of actual or previous level of alpha-fetoprotein \\> 50 ng/ml\n* hepatocellular carcinoma\n* diabetes mellitus type I"}, 'identificationModule': {'nctId': 'NCT01553500', 'acronym': 'GC-NASH', 'briefTitle': 'Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Bambino Gesù Hospital and Research Institute'}, 'officialTitle': 'Study of the Efficacy and Tolerability of Glucomannan on Children Affected by NAFLD', 'orgStudyIdInfo': {'id': 'OPBG_GLUCO_2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'glucomannan', 'interventionNames': ['Dietary Supplement: glucomannan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Behavioral: lifestyle intervention']}], 'interventions': [{'name': 'glucomannan', 'type': 'DIETARY_SUPPLEMENT', 'description': 'glucomannan is administered at dosage of 5g/day in form of biscuits (6 biscuits/day)', 'armGroupLabels': ['glucomannan']}, {'name': 'lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00165', 'city': 'Rome', 'country': 'Italy', 'facility': "Bambino Gesù Children's Hospital and Research Institute", 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Valerio Nobili, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Bambino Gesù Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bambino Gesù Hospital and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Valerio Nobili', 'investigatorAffiliation': 'Bambino Gesù Hospital and Research Institute'}}}}