Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-27 @ 5:05 AM
Study NCT ID:
NCT06148259
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2023-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SGLT Inhibitors Versus DDP4 Inhibitors and Prostate in Patient With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'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': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-19', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-11-19', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in prostate volume', 'timeFrame': 'one year', 'description': 'The delta change in prostate volume as measured by Ultrasound'}, {'measure': 'Change in prostate symptoms', 'timeFrame': 'one year', 'description': 'As indicated by change in the International prostate score system'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The study aims to compare the effect of two different classes of anti- diabetes medications on prostate volume and symptoms in elderly patients with diabetes mellitus', 'detailedDescription': 'The study aims to compare the effect of two different classes of anti- diabetes medications on prostate volume and symptoms in elderly patients with diabetes mellitus The study compares sodium glucose cotransporter 2 inhibitors to Dipeptidyl peptidase 4 inhibitors in elderly patients with type 2 diabetes mellitus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Male patients with benign prostatic hyperplasia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diabetes and benign prostatic hyperplasia should be on monotherapy with either SGLT inhibitor or DDP4 inhibitors\n\nExclusion Criteria:\n\n* unable to consent to the blood sampling or ultrasound Any other diabetes control measure other than SGLT inhibitors or DDP 4 inhibitors'}, 'identificationModule': {'nctId': 'NCT06148259', 'briefTitle': 'SGLT Inhibitors Versus DDP4 Inhibitors and Prostate in Patient With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Comparison of Two Novel Anti Diabetes Medications Classes as Regard Prostate Symptoms in Patient With Diabetes', 'orgStudyIdInfo': {'id': 'N-136-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium glucose cotransporter 2 inhibitors', 'description': 'patients with diabetes treated with sodium glucose cotransporter 2- Dapagliflozin', 'interventionNames': ['Other: International prostate symptom score', 'Diagnostic Test: Assessment of prostate volume', 'Other: Pittsburgh sleep quality Index', 'Diagnostic Test: Glycated hemoglobin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dipeptidyl peptidase 4 inhibitors', 'description': 'patients with diabetes treated with Dipeptidyl peptidase 4 inhibitor-sitagliptin', 'interventionNames': ['Other: International prostate symptom score', 'Diagnostic Test: Assessment of prostate volume', 'Other: Pittsburgh sleep quality Index', 'Diagnostic Test: Glycated hemoglobin']}], 'interventions': [{'name': 'International prostate symptom score', 'type': 'OTHER', 'description': 'Questionnaire of 8 questions to be administered to all patients about prostate symptoms', 'armGroupLabels': ['Dipeptidyl peptidase 4 inhibitors', 'Sodium glucose cotransporter 2 inhibitors']}, {'name': 'Assessment of prostate volume', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurements using ultrasound', 'armGroupLabels': ['Dipeptidyl peptidase 4 inhibitors', 'Sodium glucose cotransporter 2 inhibitors']}, {'name': 'Pittsburgh sleep quality Index', 'type': 'OTHER', 'description': 'Questionnaire to assess quality of sleep', 'armGroupLabels': ['Dipeptidyl peptidase 4 inhibitors', 'Sodium glucose cotransporter 2 inhibitors']}, {'name': 'Glycated hemoglobin', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measures control of diabetes', 'armGroupLabels': ['Dipeptidyl peptidase 4 inhibitors', 'Sodium glucose cotransporter 2 inhibitors']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo university hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Tarek Abdelaziz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University Kasr Alainy Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of Internal medicine and nephrology', 'investigatorFullName': 'Tarek Samy Abdelaziz', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}