Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-10 @ 2:43 PM
Study NCT ID:
NCT00820651
Status:
COMPLETED
Last Update Posted:
2012-04-26
First Post:
2009-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-25', 'studyFirstSubmitDate': '2009-01-09', 'studyFirstSubmitQcDate': '2009-01-09', 'lastUpdatePostDateStruct': {'date': '2012-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 52 weeks (end of the treatment) as compared with pre-treatment liver biopsy.', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'Insulinresistance levels (HOMA-IR) at 52 weeks (end of the treatment), Aminotransferase levels at 52 weeks (end of the treatment), Body weight, Body Mass Index and waist circumference at 52 weeks (end of the treatment)', 'timeFrame': '52 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nonalcoholic steatohepatitis', 'Insulinresistance', 'Diet and exercise', 'Nutritional supplement', 'Nonalcoholic fatty liver disease', 'Lifestyle modifications'], 'conditions': ['Nonalcoholic Steatohepatitis', 'Insulin Resistance']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Hernandez Yero JA, Vargas Gonzalez D. Utilidad de Diamel en pacientes con diabetes mellitus tipo 2 en tratamiento combinado con glibenclamida. Avances en Diabetología 23(1):284-290, 2007'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate whether the addition of Diamel, a nutritional supplement, to hypocaloric diet and exercise could improve the histological results (steatosis, necro-inflammatory activity and fibrosis), insulin resistance, aminotransferase levels and anthropometric measures in comparison with a placebo-controlled group with hypocaloric diet and exercise during 52 weeks of treatment in patients with nonalcoholic steatohepatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological diagnosis of steatohepatitis (minimal histological criteria for steatohepatitis include steatosis involving at least 5% of hepatocytes, lobular inflammation, and/or fibrosis)\n* Age between 18 and 70 years\n* Ability to provide informed consent\n* Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)\n\nExclusion Criteria:\n\n* Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and α-1 antitrypsin deficiency)\n* Pregnancy or lactation\n* Decompensated cirrhosis\n* Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery\n* Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil\n* Fasting glucose levels greater than 250 mg per deciliter (13.3 mmolm per liter)\n* Contraindication to liver biopsy\n* Refusal to participate in the study\n* Concomitant disease with reduced life expectancy\n* Severe psychiatric conditions\n* Drug dependence'}, 'identificationModule': {'nctId': 'NCT00820651', 'briefTitle': 'Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Catalysis SL'}, 'officialTitle': 'Efficacy and Safety of Diamel, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized and Double Blind Controlled Study', 'orgStudyIdInfo': {'id': 'DIAMEL_NASH-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo and lifestyle counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Diamel', 'interventionNames': ['Dietary Supplement: Diamel']}], 'interventions': [{'name': 'Diamel', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Dietary supplement'], 'description': 'Diamel, a nutritional supplement, 2 oral pills (660 mg), every 8 hours, daily, during 52 weeks', 'armGroupLabels': ['Diamel']}, {'name': 'Placebo and lifestyle counseling', 'type': 'OTHER', 'otherNames': ['Placebo', 'Lifestyle modification'], 'description': 'Hypocaloric diet of 1620 kcal daily (The dietary pattern will be distributed in carbohydrates 64%, fat 22% with \\<10% of saturated fatty acids and protein 14%, and exercise)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Vedado', 'state': 'La Habana', 'country': 'Cuba', 'facility': 'National Institute of Gastroenterology', 'geoPoint': {'lat': 23.13767, 'lon': -82.39339}}], 'overallOfficials': [{'name': 'Eduardo Vilar Gomez, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Gastroenterology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catalysis SL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}