Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-16 @ 5:51 PM
Study NCT ID:
NCT02063802
Status:
UNKNOWN
Last Update Posted:
2014-02-14
First Post:
2014-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin vs Conjugated Linoleic Acid and an Intervention Program With Healthy Habits in Obese Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-08-03', 'releaseDate': '2016-06-22'}], 'estimatedResultsFirstSubmitDate': '2016-06-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D044243', 'term': 'Linoleic Acids, Conjugated'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008041', 'term': 'Linoleic Acids'}, {'id': 'D043371', 'term': 'Fatty Acids, Omega-6'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-13', 'studyFirstSubmitDate': '2014-02-12', 'studyFirstSubmitQcDate': '2014-02-13', 'lastUpdatePostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in body mass index at 4 months', 'timeFrame': 'baseline, 4 months'}, {'measure': 'Change in body fat mass at 4 months', 'timeFrame': 'baseline, 4 months'}, {'measure': 'Change in lean body mass at 4 months', 'timeFrame': 'baseline, 4 months'}], 'secondaryOutcomes': [{'measure': 'Change in clinical laboratory values at 4 months', 'timeFrame': 'baseline, 4 months'}, {'measure': 'Change in M Value in CLAMP at 4 months', 'timeFrame': 'baseline, 4 months'}, {'measure': 'Change in muscle tissue transcriptome at 4 months', 'timeFrame': 'baseline, 4 months'}, {'measure': 'Change in adipose tissue transcriptome at 4 months', 'timeFrame': 'baseline, 4 months'}, {'measure': 'Change in inflammatory cytokines al 4 months', 'timeFrame': 'baseline, 4 months'}, {'measure': 'Change in the phosphorylation of the insulin receptor in muscle tissue at 4 months', 'timeFrame': 'baseline, 4 months'}, {'measure': 'Change in the phosphorylation of the insulin receptor in adipocytes at 4 months', 'timeFrame': 'baseline, 4 months'}, {'measure': 'Change in activation status of proteins involved in insulin signaling of myocytes cDNA at 4 months', 'timeFrame': 'baseline, 4 months'}, {'measure': 'Number of Participants with Serious and Non-Serious Adverse Events', 'timeFrame': 'up to 4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatric obesity', 'conjugated linoleic acid', 'CLA', 'metformin'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '27778642', 'type': 'DERIVED', 'citation': 'Garibay-Nieto N, Queipo-Garcia G, Alvarez F, Bustos M, Villanueva E, Ramirez F, Leon M, Laresgoiti-Servitje E, Duggirala R, Macias T, Cuevas S, Jalife A, Fonseca-Sanchez M, Serratos F, Lopez-Alvarenga JC. Effects of Conjugated Linoleic Acid and Metformin on Insulin Sensitivity in Obese Children: Randomized Clinical Trial. J Clin Endocrinol Metab. 2017 Jan 1;102(1):132-140. doi: 10.1210/jc.2016-2701.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to examine the effects of conjugated linoleic acid (CLA) vs metformin along with an intervention program with healthy habits on body composition, weight, M value in CLAMP and clinical laboratory values, as well as molecular and genetic changes in obese children.\n\nPatients from the pediatric service of the Hospital from 8 to 18 years old with a body mass index ≥ Pc 95 and 35kg/m2 are randomized to either interventional group for 4 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes between 8 and 18 years old\n* Pc BMI ≥ 95 and \\<35kg/m2,\n* No endocrine diseases, including diabetes mellitus\n* No systemic diseases\n* No genetic diseases\n* No pharmacological treatment affecting lipid metabolism or glucose\n* No history of acute or prolonged immobilization\n* Normal aminotransferases\n* Signed Informed consent and assent'}, 'identificationModule': {'nctId': 'NCT02063802', 'briefTitle': 'Metformin vs Conjugated Linoleic Acid and an Intervention Program With Healthy Habits in Obese Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Silanes S.A. de C.V.'}, 'officialTitle': 'Effect of an Intervention Program With Healthy Habits Plus Metformin or Conjugated Linoleic Acid Over Clinical Parameters and Molecular Pathways of Insulin Resistance in Obese Pediatric Patients', 'orgStudyIdInfo': {'id': 'DI/11/311/04/108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'metformin and healthy habits program', 'description': '1 gr per day. (250mg tablets). The patient takes 2 tablets with breakfast and 2 tablets with dinner and 2 placebo tablets with food by mouth for four months.', 'interventionNames': ['Drug: metformin', 'Behavioral: Healthy habits program']}, {'type': 'EXPERIMENTAL', 'label': 'Conjugated Linoleic Acid and healthy habits', 'description': 'Total dose: 3gr per day (500mg capsules). The patient takes 2 capsules with breakfast, 2 capsules with lunch and 2 capsules with dinner by mouth for four months.', 'interventionNames': ['Dietary Supplement: Conjugated Linoleic Acid', 'Behavioral: Healthy habits program']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and healthy habits program', 'description': 'Total dose 6 tablets per day. The patient takes 2 tablets with breakfast, two tablets with lunch and two tablets with dinner by mouth for four months.', 'interventionNames': ['Drug: Placebo', 'Behavioral: Healthy habits program']}], 'interventions': [{'name': 'metformin', 'type': 'DRUG', 'description': 'total dose: 1 gr per day (250mg tablets). The patient takes 2 tablets with breakfast and 2 tablets with dinner and 2 placebo tablets with food by mouth for four months.', 'armGroupLabels': ['metformin and healthy habits program']}, {'name': 'Conjugated Linoleic Acid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'total dose: 3gr/día(500mg capsules). The patient takes 2 capsules with breakfast, 2 capsules with lunch and 2 capsules with dinner for four months.', 'armGroupLabels': ['Conjugated Linoleic Acid and healthy habits']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Total dose 6 tablets per day. The patient takes 2 tablets with breakfast, two tablets with lunch and two tablets with dinner by mouth for four months', 'armGroupLabels': ['Placebo and healthy habits program']}, {'name': 'Healthy habits program', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Conjugated Linoleic Acid and healthy habits', 'Placebo and healthy habits program', 'metformin and healthy habits program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06726', 'city': 'Mexico City', 'state': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Nayely G Garibay, Pediatrician', 'role': 'CONTACT', 'email': 'gngaribay@hotmail.com', 'phone': '+52 (55) 59-48-26-37'}, {'name': 'Mayra A Bustos, Doctor', 'role': 'CONTACT', 'email': 'mayibe2609@gmail.com', 'phone': '+52 7773406509'}], 'facility': 'General Hospital of Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Jorge A Gonzalez, Director', 'role': 'CONTACT', 'email': 'jogonzalez@silanes.com.mx', 'phone': '521 (55)54883761', 'phoneExt': '3761'}, {'name': 'Yulia Romero, Coordinator', 'role': 'CONTACT', 'email': 'Yromero@silanes.com.mx', 'phone': '521 (55)54883700', 'phoneExt': '3777'}], 'overallOfficials': [{'name': 'Nayely G Garibay, Pediatrician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General de México'}, {'name': 'Gloria E Queipo, M.Specialist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General de México'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Silanes S.A. de C.V.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hospital General de Mexico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-06-22', 'type': 'RELEASE'}, {'date': '2016-08-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Laboratorios Silanes S.A. de C.V.'}}}}