Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-06 @ 5:41 PM
Study NCT ID:
NCT05347459
Status:
UNKNOWN
Last Update Posted:
2022-07-26
First Post:
2022-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Protective Effect of Newer Antidiabetic Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'C570240', 'term': 'empagliflozin'}, {'id': 'D000068896', 'term': 'Canagliflozin'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'C502994', 'term': 'saxagliptin'}, {'id': 'D000069476', 'term': 'Linagliptin'}, {'id': 'D000077597', 'term': 'Vildagliptin'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D011759', 'term': 'Pyrrolidines'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-24', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reduced serum inflammatory markers in intervention group', 'timeFrame': '1 Year'}], 'primaryOutcomes': [{'measure': 'Prevention of decline in cognitive function associated with type 2 diabetes', 'timeFrame': '1 Year', 'description': 'Slowed reduction of the Montreal Cognitive Assessment Battery Score'}], 'secondaryOutcomes': [{'measure': 'Better cognitive performance in the intervention group at baseline', 'timeFrame': '1 Year', 'description': 'Higher Montreal Cognitive Assessment Battery Score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The proposed study aims to:\n\n1. Explore the cognitive protective effects of SGLT2 inhibitors and DPP-4 inhibitors in patients attending diabetic clinics in Alexandria\n2. Examine the possible relationship of such effects with the systemic inflammatory and metabolic status in these patients\n3. Undertake a network analysis to elucidate the potential pathways linking the observed protective effects, if any, with the observed changes in inflammatory or metabolic parameters', 'detailedDescription': 'The investigators propose to profile diabetic patients taking SGLT2 inhibitors and DPP-4 inhibitors using different parameters and compare them to others on more traditional anti-diabetic therapy. Regression and comparative statistics will be used to determine whether the targeted drug classes offer a benefit in terms of cognitive function. If a trend (or correlation) is determined, a bioinformatic approach will be adopted to perform a network analysis including the targets of these drug classes and pathways showing in datasets of the inflammatory or metabolic parameters altered by the drug. This network analysis is intended to provide further mechanistic insight into the pathways involved in the observed drug action.\n\nThe patients targeted will be divided into the following groups:\n\n1. Diabetic patients treated with metformin and DPP-4 inhibitors and/or SGLT2 inhibitors\n2. Diabetic patients treated with metformin only\n\nThis will be in addition to a group of healthy non-diabetic controls to serve as a baseline reference.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic patients receiving care in diabetes ambulatory clinics in Alexandria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetic Patients\n* Age (≥50 Years)\n* Ability to understand and cooperate with study procedures\n\nExclusion Criteria:\n\n* Diagnosed dementia\n* Use of possible or known cognition impairing drugs in the last three months'}, 'identificationModule': {'nctId': 'NCT05347459', 'briefTitle': 'Cognitive Protective Effect of Newer Antidiabetic Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Investigating the Protective Effect of Newer Antidiabetic Drugs on Cognitive Decline in Diabetic Patients', 'orgStudyIdInfo': {'id': 'DIAB-DRUG-COG-FUN-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'New Antidiabetic', 'description': 'Type 2 diabetic patients receiving SGLT2 inhibitors and/or DPP-4 inhibitors with metformin', 'interventionNames': ['Drug: Dapagliflozin', 'Drug: Empagliflozin', 'Drug: Canagliflozin', 'Drug: Sitagliptin', 'Drug: Saxagliptin', 'Drug: Linagliptin', 'Drug: Vildagliptin']}, {'label': 'Traditional Antidiabetic', 'description': 'Type 2 diabetic patients treated with metformin'}, {'label': 'Control', 'description': 'Healthy non-diabetic patients'}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'description': 'usual and customary doses for type 2 diabetes management', 'armGroupLabels': ['New Antidiabetic']}, {'name': 'Empagliflozin', 'type': 'DRUG', 'description': 'usual and customary doses for type 2 diabetes management', 'armGroupLabels': ['New Antidiabetic']}, {'name': 'Canagliflozin', 'type': 'DRUG', 'description': 'usual and customary doses for type 2 diabetes management', 'armGroupLabels': ['New Antidiabetic']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'description': 'usual and customary doses for type 2 diabetes management', 'armGroupLabels': ['New Antidiabetic']}, {'name': 'Saxagliptin', 'type': 'DRUG', 'description': 'usual and customary doses for type 2 diabetes management', 'armGroupLabels': ['New Antidiabetic']}, {'name': 'Linagliptin', 'type': 'DRUG', 'description': 'usual and customary doses for type 2 diabetes management', 'armGroupLabels': ['New Antidiabetic']}, {'name': 'Vildagliptin', 'type': 'DRUG', 'description': 'usual and customary doses for type 2 diabetes management', 'armGroupLabels': ['New Antidiabetic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Shams T Osman, BPharm', 'role': 'CONTACT', 'email': 's-shams.mostafa@alexu.edu.eg', 'phone': '+201096900070'}, {'name': 'Ahmed F El-Yazbi, PhD', 'role': 'CONTACT', 'email': 'ahmed.fawzy.aly@alexu.edu.eg', 'phone': '+201155881772'}], 'facility': 'Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Shams T Osman, BPharm', 'role': 'CONTACT', 'email': 's-shams.mostafa@alexu.edu.eg', 'phone': '+201096900070'}, {'name': 'Ahmed F El-Yazbi, PhD', 'role': 'CONTACT', 'email': 'ahmed.fawzy.aly@alexu.edu.eg', 'phone': '+201155881772'}], 'overallOfficials': [{'name': 'Ahmed F El-Yazbi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Pharmacology and Therapeutics, Alexandria University'}, {'name': 'Labiba El-Khordagui, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Pharmaceutics, Alexandria University'}, {'name': 'Noha A Hamdy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor of Clinical Pharmacy, Alexandria University'}, {'name': 'Amr El-Feky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor of Internal Medicine, Alexandria University'}, {'name': 'Shams T Osman, BPharm', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instructor of Clinical Pharmacy, Alexandria University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data will be come available after publication and remain available indefinitely', 'ipdSharing': 'YES', 'description': 'After publication a link will be provided for a data repository folder', 'accessCriteria': 'Anyone who wishes to access the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ahmed El-Yazbi', 'investigatorAffiliation': 'Alexandria University'}}}}