Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT03137316
Status:
COMPLETED
Last Update Posted:
2017-05-02
First Post:
2017-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Secondary Hyperparathyroidism Among Patients With Diabetic Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 437}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2017-04-28', 'studyFirstSubmitQcDate': '2017-05-01', 'lastUpdatePostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intact parathyroid level', 'timeFrame': 'within 1 hour from attending in the clinic', 'description': 'intact parathyroid level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Secondary Hyperparathyroidism', 'Diabetic Nephropathies']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the prevalence of secondary hyperparathyroidism among patients with diabetic nephropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '437 diabetic patients were enrolled in this study from 864 diabetic patients who attended diabetes and nephrology outpatient clinics in our tertiary care hospital in Jeddah from Jan 2014 to Feb 2017.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\[1\\] Age was above 18 years, \\[2\\] Patient had diabetic nephropathy which was diagnosed based on the presence of urinary albumin/creatinine ratio (uACR) ≥ 30 mg/gm ± 24 hours' urinary protein measurement ≥ 300 mg/day\n\nExclusion Criteria:\n\n* \\[1\\] patients were already receiving cinacalcet and/or \\[2\\] patients had undergone neck surgery for parathyroidectomy."}, 'identificationModule': {'nctId': 'NCT03137316', 'briefTitle': 'Prevalence of Secondary Hyperparathyroidism Among Patients With Diabetic Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Prevalence of Secondary Hyperparathyroidism Among Patients With Diabetic Nephropathy', 'orgStudyIdInfo': {'id': 'BN-0418'}}, 'armsInterventionsModule': {'interventions': [{'name': 'intact parathyroid hormone level', 'type': 'DIAGNOSTIC_TEST', 'description': 'obtain intact parathyroid hormone level from patients records.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'collaborators': [{'name': 'New Jeddah Clinic Hospital', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Internal Medidicne Department- Faculty of Medicine', 'investigatorFullName': 'Mahmoud Hamada imam', 'investigatorAffiliation': 'Benha University'}}}}