Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT04043702
Status:
COMPLETED
Last Update Posted:
2019-08-02
First Post:
2019-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination of Topiramate and Empagliflozin is Considered a Good Option for the Treatment of Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-10-09', 'releaseDate': '2019-09-17'}], 'estimatedResultsFirstSubmitDate': '2019-09-17'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': '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': 'C570240', 'term': 'empagliflozin'}, {'id': 'D000077236', 'term': 'Topiramate'}], 'ancestors': [{'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-01', 'studyFirstSubmitDate': '2019-07-19', 'studyFirstSubmitQcDate': '2019-08-01', 'lastUpdatePostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in weight', 'timeFrame': '6 months', 'description': 'weight measurement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'drug combination', 'empagliflozin(jardiance)', 'topiramate(conviban)'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The aim was to show if a combination of topiramate and empagliflozin have the greatest weight decreasing effect in comparison to each drug alone and to group with no treatment( control group).\n\n.', 'detailedDescription': 'The aim was to show if a combination of topiramate and empagliflozin have the greatest weight decreasing effect in comparison to each drug alone and to group with no treatment( control group).\n\nMaterials and methods 200 obese patients 4 groups. had been monitored in a private clinic, each group 50 patients number, with 35 females and 15 males who were already on treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'obese peoples , age from 35 to 55 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. stable weight in the previous 6 months.\n2. a sedentary lifestyle.\n3. no history of diabetes mellitus.\n4. taking medication that affects appetite, or weight within the past 6 months\n\nExclusion Criteria:\n\n1. severe anemia\n2. hypothyroidism and hyperthyroidism\n3. Diabetes mellitus\n4. moderate to severe liver or kidney disease\n5. body mass index less than 30'}, 'identificationModule': {'nctId': 'NCT04043702', 'briefTitle': 'Combination of Topiramate and Empagliflozin is Considered a Good Option for the Treatment of Obesity', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health and Population, Egypt'}, 'officialTitle': 'Combination of Topiramate(Conviban) and Empagliflozin(Jardiance) is Considered a Good Option for the Treatment of Obesity', 'orgStudyIdInfo': {'id': '12345678'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'on topiramate', 'description': '"topiramate", "conviban®" group vs no treatment ( control group).', 'interventionNames': ['Drug: The intervention being studied']}, {'label': 'on empagliflozine', 'description': '"empagliflozine", "jardiance®" vs no treatment ( control group).', 'interventionNames': ['Drug: The intervention being studied']}, {'label': 'on topiramate plus empagliflozine', 'description': "all patients' vs no treatment ( control group).", 'interventionNames': ['Drug: The intervention being studied']}, {'label': 'no treatment', 'description': "all patients' vs no treatment ( control group).", 'interventionNames': ['Drug: The intervention being studied']}], 'interventions': [{'name': 'The intervention being studied', 'type': 'DRUG', 'otherNames': ['"empagliflozine", "jardiance®")', '"topiramate", "conviban®"'], 'description': 'Intervention Other Names have not been specified', 'armGroupLabels': ['no treatment', 'on empagliflozine', 'on topiramate', 'on topiramate plus empagliflozine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11759', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Mahmoud Younis', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'mahmoud younis, M.S', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'egyptian ministry of health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Health and Population, Egypt', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'mahmoud younis', 'investigatorAffiliation': 'Cairo University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-09-17', 'type': 'RELEASE'}, {'date': '2019-10-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'mahmoud younis, Principal Investigator, Cairo University'}}}}