Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT03437902
Status:
COMPLETED
Last Update Posted:
2018-05-16
First Post:
2018-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012431', 'term': 'Rutin'}, {'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D044948', 'term': 'Flavonols'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-15', 'studyFirstSubmitDate': '2018-02-10', 'studyFirstSubmitQcDate': '2018-02-15', 'lastUpdatePostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxidative stress marker (MDA) and antioxidant capacity (SOD) in diabetic patients', 'timeFrame': 'Two months', 'description': 'Effect of Rutin and vitamin C combination or vitamin C alone on oxidative stress marker (MDA) and on antioxidant capacity (SOD) in diabetic patients after 8 weeks of treatment.'}, {'measure': 'Insulin resistance in diabetic patients .', 'timeFrame': 'Two months', 'description': 'Effect of Rutin and vitamin C combination or vitamin C alone on insulin resistance in diabetic patients before i and after treatment for 8 weeks .'}, {'measure': 'Lipid profile in diabetic patients (TC,TG,HDL-c,LDL-c).', 'timeFrame': 'Two months', 'description': 'Impact of Rutin and vitamin C combination or vitamin C alone on lipid profile in diabetic patients (TC,TG,HDL-c,LDL-c).'}], 'secondaryOutcomes': [{'measure': 'Quality of life of diabetic patients and this will be evaluated by using Quality of Life Questionnaire (Short Form 36 questions (SF-36)) .', 'timeFrame': 'Two months', 'description': 'The effect of Rutin and vitamin C combination on quality of life of diabetic patients before and after treatment for 8 weeks and this will be evaluated by using Quality of Life Questionnaire (Short Form 36 questions (SF-36)) .'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'Rutin', 'Vitamin C', 'oxidative stress', 'Insulin resistance', 'lipid profile'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '31987106', 'type': 'DERIVED', 'citation': 'Ragheb SR, El Wakeel LM, Nasr MS, Sabri NA. Impact of Rutin and Vitamin C combination on oxidative stress and glycemic control in patients with type 2 diabetes. Clin Nutr ESPEN. 2020 Feb;35:128-135. doi: 10.1016/j.clnesp.2019.10.015. Epub 2019 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the effect ofRutin and Vitamin C combination in comparison with vitamin C alone on the oxidative and antioxidative status , insulin resistance and lipid profile in type 2 diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • Patients' age 35 years or older having type 2 diabetes mellitus.\n\n * Patients taking oral diabetic medications (Sulfonylurea) not taking Insulin.\n * Able to understand and willing to sign a written informed consent document\n\nExclusion Criteria:\n\n* • Pregnant and breast feeding females\n\n • use of vitamin supplements containing vitamin C or other antioxidants.\n* patients with renal or hepatic failure.\n* patients taking insulin as antidiabetic treatment"}, 'identificationModule': {'nctId': 'NCT03437902', 'briefTitle': 'Impact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of the Impact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'PHCL39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rutin C group', 'description': 'patients will receive Rutin 60 mg in combination with vitamin C 160 mg three times daily in addition to usual antidiabetic treatment for 8 weeks..', 'interventionNames': ['Dietary Supplement: Rutin in combination with Vitamin C']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin C group', 'description': 'patients will receive vitamin C 500 mg once daily in addition to usual antidiabetic treatment for 8 weeks.', 'interventionNames': ['Dietary Supplement: Vitamin C']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'patients will receive their usual antidiabetic treatment only for 8 weeks.'}], 'interventions': [{'name': 'Rutin in combination with Vitamin C', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Rutin and Vitamin C will be supplied as tablets containing 60 mg Rutin and 160 mg Vitamin C. The use of Rutin and Vitamin C will be under the trade name of RUTA C 60 ® manufactured by KAHIRA PHARM.\\& CHEM. IND. Company', 'armGroupLabels': ['Rutin C group']}, {'name': 'Vitamin C', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Ascorbic acid'], 'description': 'Vitamin C will be supplied as capsules containing500 mg of Vitamin C. The use of Vitamin C will be under the trade name of C-Retard ® manufactured by HIKMA Quality Company.', 'armGroupLabels': ['Vitamin C group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'sara R Ragheb, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'sara ramzy ragheb', 'investigatorAffiliation': 'Ain Shams University'}}}}