Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-02 @ 9:33 AM
Study NCT ID:
NCT03685357
Status:
UNKNOWN
Last Update Posted:
2018-09-27
First Post:
2018-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Idiopathic Parkinson's Disease and Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood Samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-25', 'studyFirstSubmitDate': '2018-09-22', 'studyFirstSubmitQcDate': '2018-09-24', 'lastUpdatePostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "UPDRS (Unified Parkinson's Disease Rating) Scale)", 'timeFrame': 'Baseline', 'description': "Association between glucose level and motor complication of L-dopa among Idiopathic , , Parkinson's patients using Unified Parkinson's Disease Rating Scale (UDPRS)., high scores mean worsen condition"}, {'measure': 'Oral Glucose Tolerance Test', 'timeFrame': '0, 0.5 hour , 1 hour, 1.5 hour , 2 hour', 'description': "Between Idiopathic Parkinson's patients and the Control group"}, {'measure': 'RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire)', 'timeFrame': 'Baseline', 'description': 'among Diabetic Patients, total score 13 , high scores mean worsen condition'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Observation']}, 'referencesModule': {'references': [{'pmid': '34804608', 'type': 'DERIVED', 'citation': "AwadAllah Elgnainy A, Hamed MI, Osman Mohamed W, Sabri NA. Investigation of the Possible Correlation between Idiopathic Parkinson's Disease and Diabetes Mellitus in Egyptian Patients: A Pilot Study. Neurol Res Int. 2021 Nov 12;2021:2838669. doi: 10.1155/2021/2838669. eCollection 2021."}]}, 'descriptionModule': {'briefSummary': "Correlation between Idiopathic Parkinson's disease and diabetes mellitus in Egyptian Elderly Patients", 'detailedDescription': '1. Record RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire) total score difference between Group 1 and Group 2 .\n2. Oral glucose tolerance test will be performed and compared between Group 3 and Group 4.\n3. Association between glucose level and motor complication of L-dopa among Idiopathic Parkinson\'s patients using Unified Parkinson\'s Disease Rating Scale (UDPRS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Egyptian Elderly', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diabetic Patients\n2. Idiopathic Parkinsonism\n\nExclusion Criteria:\n\n1. Secondary Parkinsonism due to stroke, trauma and encephalitis.\n2. Drug induced Parkinsonism.'}, 'identificationModule': {'nctId': 'NCT03685357', 'briefTitle': "Correlation Between Idiopathic Parkinson's Disease and Diabetes Mellitus", 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': "Investigation of the Possible Correlation Between Idiopathic Parkinson's Disease and Diabetes Mellitus in Egyptian Elderly Patients", 'orgStudyIdInfo': {'id': 'AinShamsUni Afnan'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Idiopathic Parkinson's", 'description': "Oral glucose tolerance test\n\nThe Unified Parkinson's Disease Rating Scale (UDPRS)."}, {'label': 'Diabetics receive sulphonylurea group', 'description': 'Record RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire) total score'}, {'label': 'Diabetics on sulphonylurea and metformin', 'description': 'Record RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire) total score'}, {'label': 'Healthy', 'description': 'Record RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire) total score\n\nOral glucose tolerance test'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Afnan Elgnainy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AinShams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Afnan Elgnainy', 'role': 'CONTACT', 'email': 'Afnan.elgnainy@pharma.asu.edu.eg', 'phone': '01061840761'}], 'overallOfficials': [{'name': 'Afnan Elgnainy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AinShams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Al-Azhar University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master student, teaching assistant of Clinical Pharmacy', 'investigatorFullName': 'Afnan Awad-Allah Elgnainy', 'investigatorAffiliation': 'Ain Shams University'}}}}